Senior Director of US Quality Assurance

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.

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.

Join our dynamic team at Integrated Resources Inc. as a Senior Lead Quality Assurance Analyst, where you will play a crucial role in ensuring the highest quality of our software products. In this leadership position, you will oversee QA processes, mentor team members, and collaborate with cross-functional teams to enhance our testing strategies.Your expertise will guide the development of test plans, execution of test cases, and the implementation of best practices in QA methodologies. We are looking for a passionate individual who thrives in a fast-paced environment and is committed to delivering exceptional software quality.

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.

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.

Join our dynamic team at Integrated Resources, Inc. as a Quality Assurance Specialist. In this pivotal role, you will be responsible for ensuring the quality and performance of our software products through meticulous testing and analysis. You will collaborate closely with development teams to identify issues, recommend improvements, and verify that all features meet our high standards before release.

As a Software Quality Assurance Engineer at Nuclera, you will play a crucial role in ensuring the highest quality standards of our innovative software solutions. You will be responsible for developing and executing test plans, identifying bugs, and collaborating with cross-functional teams to improve our software development processes.

Join Nuvalent as a Manager in GMP Quality Assurance, where you will play a pivotal role in ensuring the highest quality standards in our manufacturing processes. You will lead a dynamic team, working collaboratively to uphold compliance with regulatory requirements and internal protocols. Your expertise will contribute to our mission of delivering innovative therapies to patients.

Join our dynamic team at Integrated Resources Inc. as a Quality Assurance Documentation Associate! In this pivotal role, you will be responsible for ensuring the accuracy and quality of our documentation processes. Your keen attention to detail and commitment to excellence will help us maintain high standards in our quality assurance practices.

Office location: Cambridge, UK – This is a hybrid role that will require some working days from our Cambridge office, with the specific schedule to be coordinated with your line manager. Candidates should be located within a reasonable commuting distance or be willing to relocate as necessary.Are you an experienced QA Analyst with a passion for open-world gameplay systems and a commitment to enhancing high-quality player experiences?As a Quality Assurance Analyst on RuneScape: Dragonwilds, you will play an integral role in ensuring the stability, performance, and enjoyment of our expansive open-world survival crafting game. You will collaborate closely with developers, designers, and producers to test complex gameplay systems, proactively identifying quality risks, and ensuring that new features perform as intended across various platforms.Your responsibilities will include taking ownership of feature testing, mentoring junior team members, and continuously refining our QA processes. This position is perfect for someone with console and PC testing experience who is adept at navigating the challenges of open-world QA and eager to enhance their technical and collaborative abilities. Key Responsibilities:Develop a comprehensive understanding of new and evolving features while providing insightful feedback on design and quality aspects.Design and implement structured test plans across gameplay systems, including survival mechanics, AI, crafting, exploration, and environmental interactions.Document and communicate defects clearly and concisely, providing actionable insights along with steps to reproduce, severity levels, and potential impacts.Engage in test strategy discussions to evaluate system interactions, identify coverage gaps, and address quality risks.Conduct various testing types, including functional, regression, compatibility, and performance testing on both console and PC builds.Contribute to the assessment and enhancement of QA tools and workflows.Analyze defect trends and test outcomes to pinpoint patterns or coverage deficiencies.Work closely with development teams to clarify feature intentions, verify fixes, and ensure quality alignment.Provide informed contributions to bug triage and task prioritization discussions based on testing impacts and player experiences.Mentor and support junior testers informally, sharing knowledge and reviewing testing outputs.Maintain and update test documentation and knowledge bases, identifying gaps as necessary.Take ownership of testing for specific features or systems, diligently tracking progress and reporting risks.Build specialized expertise in selected gameplay or technical areas, establishing yourself as a go-to QA contact for those systems.

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.

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.

Join our dynamic team as a Program Manager in Research & Development Quality Assurance. In this pivotal role, you will oversee the quality assurance processes within the realm of Good Clinical Practice (GCP). Your expertise will be crucial in ensuring that our R&D initiatives meet the highest standards of quality and compliance.As a Program Manager, you will lead cross-functional teams, drive project timelines, and implement effective quality assurance strategies. This position is ideal for a proactive leader who thrives in a fast-paced environment and is passionate about delivering exceptional results in clinical research.

Scholar Rock is a pioneering biopharmaceutical firm dedicated to discovering, developing, and delivering transformative therapies for individuals afflicted by serious diseases that lack adequate treatment options. Renowned for its expertise in the biology of the transforming growth factor beta (TGFβ) superfamily, the company is committed to advancing innovative treatments where protein growth factors are essential. Over the last decade, Scholar Rock has built a robust pipeline aimed at enhancing the standard of care for conditions such as neuromuscular diseases, cardiometabolic disorders, cancer, and other illnesses where growth factor-targeted therapies can make a significant impact. Scholar Rock has distinguished itself as the sole company to demonstrate clinical proof of concept for a muscle-targeted therapy in spinal muscular atrophy (SMA). This dedication to exploring fundamentally novel therapeutic strategies is bolstered by the extensive application of a proprietary platform that has yielded innovative monoclonal antibodies to selectively modulate protein growth factors with remarkable precision. By leveraging cutting-edge scientific advancements in areas that have historically been underserved by conventional treatments, Scholar Rock strives daily to open new avenues for patients. To learn more about our approach, visit us at ScholarRock.com and follow us on @ScholarRock and on LinkedIn.Position Overview:The Senior Director of Healthcare Professional Marketing (US) will assume a pivotal leadership role in orchestrating the preparation and execution of Scholar Rock's inaugural U.S. commercial launch. This position is responsible for formulating and implementing the U.S. healthcare professional (HCP) marketing strategy and tactical execution for apitegromab, the first and only muscle-targeted therapy for spinal muscular atrophy (SMA).This individual will lead the U.S. HCP brand strategy from launch through commercialization, ensuring distinct differentiation, compelling scientific communication, and impeccable execution across all channels. Collaboration with U.S. commercial, medical, market access, and patient services teams will be essential to deliver a cohesive launch.In addition to U.S. leadership responsibilities, this role will provide limited ex-U.S. support (~10%), concentrating on strategic alignment, communication, and knowledge sharing with regional and local teams to ensure a consistent core HCP strategy while considering local requirements. This is a high-impact, high-visibility role that demands strategic thinking, strong leadership, and an unwavering commitment to advancing patient care.

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.

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.

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.

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.