Quality Assurance Documentation Associate

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.

Join Riverlane as the Director of Systems in Cambridge, UK. This is a full-time, permanent position with a hybrid working model.Compensation: £125,000 to £150,000, dependent on experience, along with bonus and equity options.We welcome applications from candidates with varying levels of experience. Salary offers will be tailored to individual backgrounds, including industry experience, transferable skills, and notable achievements.We are open to part-time applications for this role; please specify your preferred schedule in your cover letter.

Join Iterative Health as our Director of Compliance, where you will play a pivotal role in shaping our compliance strategy and ensuring adherence to regulatory requirements. This leadership position will involve developing and implementing compliance programs, monitoring compliance performance, and liaising with regulatory bodies. You will lead a team of compliance professionals and collaborate with various departments to cultivate a culture of compliance within the organization.

The Associate Director for Compliance and Title VI Coordinator plays a pivotal role in ensuring the University adheres to Title VI regulations and oversees the management of Title IX Hearings, Appellate Panels, NDAB Determination Panels, and cases under the University Committee on Rights and Responsibilities (UCRR) Fact-Finding Procedures. Reporting to the Director of the Office for Community Support, Non-Discrimination, Rights and Responsibilities (CSNDR) and the University Title IX Coordinator, this position collaborates closely with various stakeholders including the Title IX Hearing Chair and the Director of the Office for Dispute Resolution (ODR). The Associate Director provides leadership in the administration of UCRR Fact-Finding Procedures, working in conjunction with the University President and Faculty Panels. Key Responsibilities: Offer guidance and support to Hearing, Appellate, and Determination Panels, as well as local Title IX Resource Coordinators and personal advisors regarding applicable Policies and Procedures.Facilitate logistical arrangements for the University President or their designee, along with UCRR Faculty Panels.Oversee the intake process for all complaints filed under the NDAB, particularly those alleging discrimination based on Title VI protected characteristics.Prepare essential materials including summaries and notices for Hearing, Determination, and Appellate Panels.Lead the development of the Annual Report published by the Director of CSNDR, detailing complaints under the NDAB.Act as the primary liaison for communications and materials pertaining to various panels and stakeholders.Create and implement internal guidance and training resources for Hearing and Appellate Panels.

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.

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 Integrated Resources, Inc. as a Data Management Quality Associate, where you will play a crucial role in ensuring the integrity and quality of our data management processes. You will collaborate with cross-functional teams to enhance data accuracy and streamline operations.

We are seeking a dedicated and knowledgeable Senior Associate in Operational Excellence & Compliance to join our dynamic team at Integrated Resources Inc. In this pivotal role, you will contribute to enhancing our operational processes and ensuring compliance with industry regulations. You will collaborate with cross-functional teams to identify opportunities for improvement and implement best practices that drive operational efficiency.

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.

Role Overview Isomorphic Labs is seeking a Director of Computational Drug Design to join its Cambridge, MA site. This leader will shape computational chemistry strategy for both internal research and collaborative projects. The position sits within the Drug Design and Medical Research division, working closely with AI and machine learning specialists to advance the company’s drug design engine and accelerate new medicine development. About Isomorphic Labs Founded in 2021, Isomorphic Labs (IsoLabs) builds on the AlphaFold system, applying advanced AI to solve complex problems in human health. The team combines drug discovery expertise with machine learning to create predictive and generative models that speed up scientific discovery. The company’s mission is to design novel molecules, predict drug performance, and develop new treatments for challenging diseases by modeling biological systems with AI. Isomorphic Labs has developed an AI-driven drug design engine capable across various therapeutic areas and drug types. The organization continues to refine model architectures and expand capabilities, aiming to realize the promise of digital biology and ultimately eradicate disease through artificial intelligence. About the Computational Drug Design Team The Cambridge-based Computational Drug Design team brings together computational chemists focused on driving strategy, supporting both internal and partner projects. Close collaboration with AI/ML colleagues is central to the group’s work, ensuring the continued evolution of the Isomorphic Labs Drug Design Engine. The team values a supportive environment, ongoing learning, and professional development for every member.

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.

Join our dynamic team at Integrated Resources, Inc. as an Associate Director of Pharmacovigilance. In this pivotal role, you will oversee the safety and efficacy of pharmaceutical products, ensuring compliance with regulatory standards and advancing our commitment to patient safety.Your expertise in pharmacovigilance will guide our strategic initiatives, collaborating with cross-functional teams to enhance product safety and regulatory submission processes.

Riverlane seeks a Director of IT Infrastructure to lead technology operations at its Cambridge, UK headquarters. This permanent, full-time position offers a hybrid work arrangement and a salary range of £100,000 to £130,000 depending on experience. Role overview This senior leadership role oversees all aspects of IT at Riverlane, from managing corporate systems to optimizing high-performance computing (HPC) infrastructure. The Director will shape IT strategy, execute plans, and collaborate with engineering, operations, security, and finance teams to ensure infrastructure remains secure, scalable, and aligned with company growth. What you will do Lead and refine Riverlane's IT strategy, policies, and roadmap to support company objectives and security needs. Manage and improve corporate IT systems, including endpoint management, identity and access management (IAM), collaboration tools, SaaS platforms, and networking. Direct IT procurement, oversee vendor relationships, and optimize software licensing across all platforms. Establish and maintain IT support processes to ensure high availability and responsiveness for a team of scientists and engineers. Develop and manage Riverlane’s information security framework, covering policies, risk management, access controls, and compliance with standards such as ISO 27001. Compensation Salary: £100,000 to £130,000 DOE

Harvard University is hiring an Associate Director of Strategic Sourcing in IT to shape the university’s approach to acquiring technology resources. This position guides procurement strategy, leads sourcing projects, and works with IT teams to secure solutions that fit Harvard’s evolving needs. What you will do Direct strategic sourcing projects for IT products and services Negotiate contracts and oversee supplier partnerships Work with IT departments to understand their requirements and align procurement activities Promote efficiency and support innovation in technology sourcing Role impact This role contributes to Harvard’s mission by ensuring the university has access to dependable and effective technology. Decisions made in this position will influence operational efficiency and help foster ongoing innovation across campus.

Harvard University is seeking an innovative and strategic Associate Director of Research to lead groundbreaking research initiatives. The ideal candidate will possess a deep understanding of research methodologies, strong leadership skills, and a passion for academic excellence. This role involves collaborating with faculty and students to enhance research output and drive impactful scholarship.

Join Steritech as a Food Safety and Compliance SpecialistLocation: Cambridge, OntarioSteritech is a leader in food safety and quality assurance, serving as a trusted partner to some of the most recognized brands across various sectors including manufacturing, food service, retail, and hospitality. Our mission is to empower clients to deliver the safest and healthiest experiences to their customers. As part of the Rentokil Terminix family, we uphold the highest standards in food safety and compliance.Your Future Starts Here! At Steritech, we are dedicated to fostering a culture of continuous learning and professional growth. With a majority of our management team having advanced from specialist roles, we believe in nurturing talent from within. Joining our team means embarking on a career path filled with opportunities for advancement. We equip you with the necessary tools, resources, and mentorship to ensure your success, as we recognize that your achievements contribute to our collective success.As a Food Safety & Compliance Specialist, you will partner with clients in the hotel, restaurant, and grocery sectors to ensure adherence to brand standards, food quality, and exceptional service.Key Responsibilities:Conduct thorough assessments to evaluate compliance with regulatory, industry, and proprietary standards.Monitor food preparation and cooking practices to uphold food safety and sanitation standards.Collaborate with clients to identify and address the root causes of discrepancies in assessments while developing corrective action plans.Educate and guide clients on creating a safer and healthier workplace for their employees and customers.Willingness to travel up to 50% of the time by car and/or plane, approximately 10 overnight stays per month.

AbbVie is seeking a highly skilled Associate Director to lead our Safety Operations Portfolio. This pivotal role involves overseeing safety operations while ensuring compliance with regulatory requirements. The ideal candidate will possess exceptional leadership skills and a strong background in pharmacovigilance.Join our dynamic team and contribute to advancing healthcare solutions that enhance patient safety and improve health outcomes. This is an exciting opportunity for professionals looking to make a meaningful impact in the pharmaceutical industry.

The Opportunity:Relay Therapeutics is in search of an experienced and strategic regulatory leader to join our expanding regulatory team. In this pivotal role, you will define and implement groundbreaking regulatory strategies aimed at accelerating the development and approval of our innovative pipeline. As the global regulatory lead for relevant project teams, you will develop and execute comprehensive strategies for developmental programs. You will also be the primary liaison with the FDA, leading cross-functional teams to ensure successful domestic and international regulatory submissions, including IND, CTA, NDA, and MAA submissions.Your Role:Collaborate closely with regulatory, research, and development teams to design and implement innovative regulatory strategies for our dynamic programs, including both non-clinical and clinical regulatory strategies tailored to specific products.

Company Overview Fulcrum Therapeutics is an innovative clinical-stage biopharmaceutical organization dedicated to enhancing the quality of life for patients suffering from genetically defined rare diseases that exhibit a significant unmet medical need. Our proprietary product engine is adept at identifying drug targets capable of modulating gene expression to address the underlying causes of gene misexpression. We are currently advancing our flagship asset, FTX-6058 (pociredir), a small molecule engineered to elevate fetal hemoglobin expression for the treatment of sickle cell disease and beta thalassemia. Position Summary The Associate Director of Clinical Science will collaborate closely with the Executive Medical Director and VP of Clinical Development to provide critical support across one or more Clinical Project Teams at Fulcrum Therapeutics. This role is pivotal in ensuring the effective design and execution of Clinical Development Plans, focusing on crafting cost-efficient clinical trials that fulfill the needs of both internal and external stakeholders. The successful candidate will assume responsibility for the scientific oversight of clinical studies, working in partnership with study program leadership and cross-functional team members. This includes the interpretation and communication of clinical trial data, which are crucial for high-quality regulatory submissions. Key responsibilities encompass contributing to the design and execution of company-sponsored clinical trials at all developmental phases, analyzing clinical trial data, and facilitating internal and external communications regarding project plans and progress. The Associate Director will also be involved in safety monitoring and mitigation strategies, as well as making significant contributions to regulatory submissions, publications, and communications of clinical data.