Senior Director of Global Quality Control

Scholar Rock is a pioneering biopharmaceutical company dedicated to discovering, developing, and delivering transformative therapies for individuals battling serious diseases with significant unmet needs. Renowned as a global authority in the biology of the transforming growth factor beta (TGFβ) superfamily, our clinical-stage organization is passionately focused on advancing innovative treatments that are fundamentally reliant on protein growth factors. Over the last decade, we have cultivated a robust pipeline aimed at elevating the standard of care for neuromuscular diseases, cardiometabolic disorders, cancer, and various conditions where growth factor-targeted drugs can have a revolutionary impact. Scholar Rock proudly stands as the sole company to have demonstrated clinical proof of concept for a muscle-targeted therapy in spinal muscular atrophy (SMA). Our commitment to unlocking novel therapeutic avenues is driven by the extensive application of a proprietary platform that has developed unique monoclonal antibodies designed to modulate protein growth factors with remarkable precision. By leveraging cutting-edge science in disease areas that have traditionally been overlooked by conventional therapies, we strive each day to create new possibilities for patients. To learn more about our innovative approach, visit ScholarRock.com and follow us on Twitter and LinkedIn.Position Overview:We are actively seeking a highly experienced and driven Senior Director of Global Quality Control to join our team. This pivotal role reports directly to the Head of Global Quality and serves as the senior leader responsible for establishing and maintaining a scalable, phase-appropriate, and inspection-ready global QC strategy across a fully outsourced development and manufacturing network. The Senior Director will provide both strategic and technical leadership for Quality Control activities carried out through external contract laboratories, CMOs, and other testing partners, supporting drug substance, drug product, raw materials, in-process, release, and stability programs.

Relay Therapeutics is seeking a dynamic and experienced Director of Analytical Development and Quality Control to lead our analytical efforts in drug development. In this leadership role, you will oversee the development and implementation of analytical methods to support our innovative drug discovery pipeline. You will work closely with cross-functional teams to ensure optimal quality control processes and regulatory compliance.Your expertise will play a critical role in driving our mission to improve the lives of patients through cutting-edge therapies.

Scholar Rock is a pioneering biopharmaceutical entity dedicated to the discovery, development, and delivery of transformative therapies aimed at addressing significant unmet medical needs. As a recognized leader in the biology of the transforming growth factor beta (TGFβ) superfamily, and inspired by the structural resemblance of a scholar rock to protein formations, our clinical-stage company is devoted to advancing groundbreaking treatments that leverage protein growth factors. Over the last decade, we have established a robust pipeline designed to redefine the standard of care for conditions such as neuromuscular diseases, cardiometabolic disorders, and cancer, where growth factor-targeted therapies can make a substantial impact. Scholar Rock stands out as the sole organization demonstrating clinical proof of concept for a muscle-targeted therapy in spinal muscular atrophy (SMA). Our commitment to unlocking innovative therapeutic pathways is underscored by the extensive application of our proprietary platform, which has yielded novel monoclonal antibodies to selectively modulate protein growth factors. By harnessing cutting-edge scientific advancements in traditionally underserved disease areas, we strive each day to create new possibilities for patients. Discover more about our mission at ScholarRock.com and connect with us on @ScholarRock and LinkedIn.Position Overview:As Scholar Rock embarks on a pivotal phase with the impending launch of our inaugural commercial product, we are in search of a strategic and operationally-savvy Senior Director of Global Facilities. This role transcends purely administrative functions; we require a visionary builder who comprehends the intricacies of scaling infrastructure within a rapidly evolving biotech setting while adeptly navigating day-to-day operational challenges.With facilities strategically located worldwide and poised for future growth, you will be responsible for ensuring our environments are safe, compliant, efficient, and conducive to supporting both research and commercial initiatives. If you are a proactive self-starter who thrives in dynamic, transformative organizations and is eager to contribute significantly, this opportunity allows you to apply your expertise, learn extensively, and make a meaningful impact.

Join our dynamic team as a Quality Control Analyst II, where you will play a vital role in ensuring the highest standards of quality in our products. This position is ideal for detail-oriented individuals who are passionate about quality assurance and eager to contribute to the success of our projects.

We are seeking a dedicated and detail-oriented Quality Control Manager to join our dynamic team at Integrated Resources Inc. in Cambridge, Massachusetts. The ideal candidate will be responsible for ensuring the highest standards of quality across our products and services, implementing rigorous quality management systems, and leading a team of quality assurance professionals.As a Quality Control Manager, you will play a crucial role in driving continuous improvement initiatives and collaborating with cross-functional teams to enhance operational efficiency. Your expertise will help us maintain compliance with industry regulations and exceed customer expectations.

Scholar Rock is a leading biopharmaceutical firm dedicated to discovering, developing, and delivering transformative therapies for individuals suffering from serious diseases with significant unmet needs. As a pioneer in the understanding of the transforming growth factor beta (TGFβ) superfamily of proteins, we are named for the resemblance of a scholar rock to protein structures. Our clinical-stage organization is committed to advancing groundbreaking treatments where protein growth factors play a crucial role. Over the past decade, we have built a robust pipeline aimed at enhancing the standard of care for neuromuscular diseases, cardiometabolic disorders, cancer, and other conditions where growth factor-targeted treatments can have a profound impact. Scholar Rock stands out as the only company that has demonstrated clinical proof of concept for a muscle-targeted therapy in spinal muscular atrophy (SMA). Our dedication to pioneering innovative therapeutic approaches is driven by the extensive application of our proprietary platform, which has developed novel monoclonal antibodies to selectively modulate protein growth factors with remarkable precision. By leveraging advanced science in areas historically underserved by conventional therapies, Scholar Rock is consistently working to unlock new possibilities for patients. Discover more about our approach at ScholarRock.com and follow us on @ScholarRock and LinkedIn.Position Overview:We are in search of a highly skilled and driven Senior Director of US Quality Assurance to join our team. Reporting directly to the Head of Global Quality, this role will provide both strategic and operational leadership for US Quality Assurance. A strong emphasis will be placed on managing external partner governance, implementing quality risk management strategies, and establishing a scalable quality infrastructure to support our development through commercialization efforts.

Join our dynamic team as a Quality Assurance/Quality Control Specialist III. In this pivotal role, you will ensure the highest quality standards are maintained throughout our processes and products. As a QA/QC Specialist, you will be responsible for developing and implementing quality assurance programs, conducting audits, and collaborating with cross-functional teams to drive continuous improvement.

Amylyx Pharmaceuticals Inc. is on a bold mission to innovate the treatment landscape for diseases with significant unmet needs. Instead of viewing challenges as roadblocks, we embrace them as opportunities to advance solutions with urgency, scientific rigor, and a steadfast commitment to the communities we serve. As a clinical-stage company, we are currently addressing conditions such as post-bariatric hypoglycemia (PBH), Wolfram syndrome, and amyotrophic lateral sclerosis (ALS).Our mission thrives on the passion of our people. We embody core values of audacity, curiosity, authenticity, engagement, and accountability, fostering a culture of care. With a seasoned team ready to make impactful changes, we invite you to join us in this endeavor if you share our enthusiasm for tackling some of the most challenging issues in medicine.The OpportunityAmylyx Pharmaceuticals Inc. is seeking a seasoned Senior Director of Chemistry, Manufacturing, and Controls (CMC) to lead our CMC organization in the development of our pipeline, including Phase III synthetic peptide Avexitide and Phase I antisense oligonucleotide AMX0114. The CMC team partners with external CDMOs to implement robust, scalable, and compliant processes for clinical and commercial supply. This role may involve direct leadership or managing leads of internal matrix CMC Asset teams, serving as the CMC representative on Asset program teams. This leader will collaborate across functions to drive technical excellence and ensure CMC alignment with program objectives.The ideal candidate will exhibit strong strategic leadership while actively engaging in hands-on execution as needed. This position reports to the Senior Vice President of Global CMC and External Manufacturing.

We are seeking a highly skilled and experienced Director of Clinical Quality to join our dynamic team at Integrated Resources, Inc. In this pivotal role, you will be responsible for overseeing the clinical quality management systems, ensuring compliance with regulatory standards, and driving continuous improvement in clinical processes.Your leadership will be vital in fostering a culture of quality and safety, collaborating with multidisciplinary teams to enhance patient outcomes and operational efficiency.

Amylyx Pharmaceuticals is on a bold mission to revolutionize the treatment of diseases that have significant unmet needs. We view challenges as opportunities to pursue with urgency, scientific rigor, and an unwavering commitment to the communities we serve. As a clinical-stage company, we are dedicated to tackling complex conditions including post-bariatric hypoglycemia (PBH), Wolfram syndrome, and amyotrophic lateral sclerosis (ALS).Powered by our dedicated team, our core values—be audacious, be curious, be authentic, be engaged, and be accountable—foster a caring culture. We are seeking passionate individuals who are eager to confront some of medicine’s most pressing challenges. If you are ready to take action, we invite you to explore the opportunity below and apply.The OpportunityThe Senior Director of Market Insights is a pivotal leadership role that will drive the comprehensive insights strategy to facilitate U.S. commercialization and global expansion. As the strategic owner of the insights function, you will ensure the integration of market intelligence, analytics, and evidence generation into corporate decision-making throughout the product lifecycle.Reporting to the Vice President of Commercial Operations, you will be a key advisor to both commercial and executive leadership, shaping strategies with insights that guide launch readiness, lifecycle management, and portfolio prioritization. This role requires adeptness at both strategic and operational levels, building scalable frameworks to support a multi-asset, multi-market organization.

Join our dynamic team at Turner Townsend as a Cost/Senior Cost Controller in a collaborative hybrid working environment. We are looking for a skilled individual who is adept at managing project costs, ensuring financial accuracy, and providing insightful analysis to enhance decision-making.Your role will involve close collaboration with project teams, offering financial guidance and oversight to ensure projects are delivered on time and within budget. You will leverage your expertise in cost management to facilitate effective financial reporting and forecasting.

Join Flagship Pioneering Inc. as the Director/Senior Director of Compensation, where you will lead the strategic development and execution of our compensation programs. Your role will involve designing competitive compensation structures, ensuring alignment with industry standards, and driving initiatives that enhance employee engagement and performance. You will collaborate with senior leadership to shape compensation policies that reflect our commitment to attracting and retaining top talent.

Amylyx Pharmaceuticals is dedicated to revolutionizing the treatment of diseases with significant unmet needs. We embrace challenges as opportunities, driven by a sense of urgency, rigorous scientific methodology, and a steadfast commitment to the communities we serve. Our focus is on clinical-stage development for conditions such as post-bariatric hypoglycemia (PBH), Wolfram syndrome, and amyotrophic lateral sclerosis (ALS).Our mission thrives on our talented team, which embodies core values of audacity, curiosity, authenticity, engagement, and accountability — all of which foster a culture of care. Amylyx has curated a skilled workforce ready to act swiftly because the communities we support cannot afford to wait. If you are passionate about addressing some of the most challenging issues in medicine, we invite you to explore the opportunity below and apply.The OpportunityThe Associate Director of Computer System Validation (CSV) & Quality Compliance will provide enterprise-level leadership, strategic direction, and governance for the validation, lifecycle management, and continuous compliance of GxP-relevant computerized systems, particularly focusing on the Veeva Quality Suite. This position is pivotal in ensuring that our digital quality solutions and supporting systems comply with global regulatory standards (FDA, EMA, ICH, GAMP 5), safeguard data integrity, and maintain a sustainable, inspection-ready status across the organization.This role entails close collaboration with Quality, IT, Regulatory, Clinical, and business process owners to define system requirements, oversee new system implementations and significant enhancements, and promote harmonized, risk-based validation practices. Additionally, this position supervises quality compliance processes such as Change Control, Deviations, CAPA, and continuous improvement, ensuring timely resolutions, trend analysis, and effective governance through leadership of key forums, including Quality Management Review and cross-functional compliance meetings.

About Flagship Pioneering, Inc. Flagship Pioneering is at the forefront of innovation, dedicated to inventing and nurturing platform companies that have the potential to revolutionize human health, sustainability, and more. Since our inception in 2000, we have successfully launched over 100 companies that tackle some of the world's most pressing challenges, such as vaccinating billions against COVID-19, curing difficult diseases, enhancing human health, preventing illness, and improving agricultural resilience and sustainability. Our commitment to impactful innovation has earned us recognition on FORTUNE's 'Change the World' list, highlighting companies that make a significant social and environmental impact, and we have appeared on Fast Company's annual list of the World’s Most Innovative Companies. Position Summary: We are looking for a passionate and experienced individual to join our Communications and Public Affairs team as the Senior Director of Communications. In this role, you will spearhead the development and implementation of communications and branding strategies for a selection of companies within Flagship Pioneering's diverse portfolio. The ideal candidate will possess a robust background in biotech corporate communications and excel in a fast-paced, startup atmosphere. This is a remarkable opportunity to influence the trajectory of groundbreaking life sciences and technology firms across human health, agriculture, and AI sectors. This full-time role requires in-office presence four days a week in Cambridge, MA. Key Responsibilities: Provide strategic counsel to the founders and leadership of emergent Flagship companies (Flagship NewCos) in developing their brand, voice, foundational messaging, and overall communication strategies. Oversee brand development, visual identity, and website design for NewCos, collaborating with external agencies. Create and implement tailored, integrated communication strategies for company launches, encompassing all written content, media engagement, and social media components. Manage PR agency support as necessary. Develop and execute communication strategies for both NewCos and more established companies (Flagship GrowthCos), including milestone announcements, internal communications, social and digital media strategies, speaking opportunities, and issue management, in close collaboration with company leadership.

The Opportunity: Join Relay Therapeutics as a Senior Medical Director, where you will be pivotal in propelling our clinical pipeline from IND to proof of concept and ultimately to registration. In this role, you will partner with senior medical staff to shape clinical strategies, design clinical trials, and ensure successful execution. Collaborating across various functions including clinical project management, regulatory affairs, clinical operations, biostatistics, data management, and medical writing, you will significantly contribute as Relay Therapeutics continues to advance product candidates into clinical settings. You will provide clinical leadership to R&D teams and closely collaborate with Development leadership. We are open to remote employees

We are seeking a seasoned Senior Lead Quality Assurance Analyst to join our dynamic team in Cambridge. In this pivotal role, you will lead QA initiatives, ensuring that our products meet the highest standards of quality and performance. You will collaborate closely with cross-functional teams to develop effective testing strategies and oversee the implementation of quality assurance processes.

Your Role at Lila Sciences Lila Sciences stands at the forefront of scientific innovation, operating as the world’s first scientific superintelligence platform and autonomous laboratory dedicated to life sciences, chemistry, and materials science. Our mission is to revolutionize the process of scientific discovery by seamlessly integrating AI into every facet of the scientific method, empowering researchers to address humanity’s most pressing challenges in health, climate change, and sustainability at unprecedented speed and scale. Position Overview As the Director/Senior Director of Applied AI, you will spearhead the establishment of our foundational Applied AI team, responsible for refining and adapting our AI models for practical product deployment. You will ensure their safe integration with diverse customer datasets and oversee the development of high-performance interfaces, including chat experiences and inference endpoints like gRPC, HTTP, and PCP servers. Reporting directly to the CTO, you will manage the complete roadmap from data acquisition to model deployment, collaborating closely with Research, Product, Software, Application, Safety, and Security teams to deliver models that are functional, quantifiable, and dependable. Key Responsibilities Lead and mentor a high-performing Applied AI team to produce exceptional scientific reasoning models for consumer applications. Manage an end-to-end model customization pipeline to generate impactful models from Lila’s base models for high-value applications, including inference, chat, and API integration. Develop a comprehensive evaluation framework to facilitate ongoing model enhancement and performance optimization. Collaborate with cross-functional teams to define project requirements, deliver customer proofs of concept (POCs), and transition successful pilots into scalable products. Establish technical standards, documentation, and incident response protocols for AI systems in production. Recruit, mentor, and foster a diverse and inclusive team environment. Qualifications for Success 8+ years of experience in applied machine learning or ML systems, with a minimum of 3 years in a leadership role; proven track record of deploying large language models (LLMs) into production. Extensive experience in fine-tuning and evaluating large-scale models for customer interactions. Production inference expertise, including familiarity with serving frameworks (Triton, vLLM, TGI, Ray, Kubernetes), GPU orchestration, caching, and observability. Strong understanding of data privacy and security best practices in multi-tenant systems. Preferred Qualifications Experience with instruction fine-tuning and optimization techniques. Proficiency in developing chat user experiences, implementing guardrails, tool/function calling, and managing long-context interactions.

We are seeking a highly skilled and detail-oriented Senior Associate specializing in Controlled Document Management to join our dynamic team. In this pivotal role, you will oversee the management, organization, and compliance of critical documentation, ensuring adherence to regulatory standards and internal protocols. Your expertise will contribute to maintaining the integrity and accessibility of essential documents across the organization.

Company Overview:Atavistik Bio is a leading, privately-held biotechnology firm at the forefront of developing groundbreaking precision allosteric therapeutics aimed at addressing significant unmet medical needs. With our innovative AMPS™ platform, we swiftly uncover functional cryptic pockets across various target classes, enhancing the speed of medicine development. Our growing portfolio of allosteric therapeutics shows promise for superior efficacy and tolerability, leveraging the unique advantages of allostery.Atavistik Bio is spearheaded by a team of seasoned drug hunters with extensive experience in bringing marketed small molecule therapies to fruition, backed by distinguished investors including The Column Group, Nextech Invest, Lux Capital, and Regeneron Ventures.Position Overview:We are on the lookout for a dynamic and strategic Senior Director of Toxicology to become a vital member of our development team. This role involves collaborating with a passionate group of adept scientists within a vibrant, rapidly evolving organization. Reporting directly to the Chief Scientific Officer, the successful candidate will oversee the design, execution, and analysis of all nonclinical safety studies essential for discovery, IND-enabling, and late-stage clinical development. This position will lead toxicology efforts across diverse programs, ensuring the delivery of high-quality data packages for regulatory submissions. Join us in shaping a pioneering toxicology function in an exhilarating clinical-stage environment.

Join Amylyx Pharmaceuticals, Inc. as the Senior Director of Patient Services, where you will lead initiatives aimed at enhancing patient experience and access to our innovative treatments. You will be responsible for developing and implementing strategic plans that prioritize patient needs, while collaborating with cross-functional teams to ensure the highest quality of services is delivered.