{"id":2669422,"url":"https://alion.io/job/amylyx-associate-director-commercial-quality-control","title":"Associate Director, Commercial Quality Control","company":{"id":2594505,"name":"Amylyx","domain":"amylyx.com","url":"https://alion.io/company/amylyx","size_band":"51-200","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Greenhouse","truth_index":{"grade":"A","score":95,"open_postings":3,"ghost_share":0,"stale_share":0,"repost_share":0,"time_to_fill_p50_days":67,"computed_at":"2026-11-03T05:54:40Z"}},"role":"Early Careers","role_family":"Early Careers","seniority":"head","employment_type":null,"work_mode":"remote","remote_scope":"stated_countries","remote_scope_basis":"posting_text","remote_working_hours":null,"hiring_geo_confidence":"inferred","locations":["Cambridge, United States"],"countries":["US"],"hiring_countries":["US"],"hiring_countries_total":1,"salary":{"min":171000,"max":192000,"currency":"USD","period":"year","gross":null,"usd_annual":192000},"salary_estimate":null,"experience_years_min":8,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"CAPA","optional":false},{"name":"GMP","optional":false},{"name":"Wolfram","optional":false}],"status":"closed","first_seen_at":"2026-10-05T15:40:35Z","employer_posted_date":"2026-10-06","last_verified_at":"2026-11-03T13:45:52Z","board_verified":false,"closed_at":"2026-11-03T13:45:52Z","days_open":28,"trust":{"level":"not_scored","repost_count":null,"flags":[],"days_open":28},"description":"Amylyx has an audacious mission to usher in a new era for treating diseases with high unmet needs. Where others see challenges, we see opportunities that we pursue with urgency, rigorous science, and unwavering commitment to the communities we serve. We are a clinical-stage company currently focused on post-bariatric hypoglycemia (PBH), Wolfram syndrome, and amyotrophic lateral sclerosis (ALS).\nOur mission is powered by our people. Our core values - be audacious, be curious, be authentic, be engaged, and be accountable - creating a culture of caring. Amylyx has assembled an experienced team ready to take action because the communities we serve have no time to wait. If you share our passion and are determined to tackle some of medicine’s toughest problems, we encourage you to read the opportunity below and apply.\nThe Opportunity\nThe Quality Operations team is expanding and looking to hire an Associate Director of Quality Control reporting to the Senior Director of QC/AD. This individual will be responsible for commercial readiness and ongoing commercial QC operations. This position is a key QC leader responsible for advancing an inspection-ready, globally compliant commercial QC team within a fully outsourced manufacturing and testing network. The ideal candidate will be a motivated, organized, self-starter, willing to actively collaborate cross functionally and excited about the potential to deliver therapies to patients in need.\nResponsibilities\nLead and manage Amylyx’ commercial QC function across external CMOs and CTLs supporting commercial raw material, drug substance, drug product and finished drug product in-process, release and stability testing.\nMonitor quality and operational performance of external testing partners through governance, metrics, trend reviews, deviation/investigation and CAPA oversight\nProvide oversight of commercial stability programs, including protocol governance, pull schedule adherence, data review and trending, shelf-life support, annual stability commitments, comparability assessments, and post-approval stability requirements.\nManage commercial specification lifecycle activities, including implementation of approved specifications, post-approval revisions, change assessments, market-specific requirements, comparability impacts, and coordination with Regulatory Affairs and external partners.\nEnsure effective lifecycle management of commercial analytical methods, including validation maintenance, transfer, verification, method performance monitoring, troubleshooting, and change implementation across outsourced laboratories.\nAuthor, review, and approve commercial QC-related documents, including specifications, stability protocols and reports, method transfer and validation documents, SOPs, technical assessments, annual product quality review inputs.\nCollaborate cross functionally with Manufacturing, Supply Chain, Regulatory Affairs, Analytical Development, and Quality Assurance to support commercial lot release, global market supply, process changes, comparability assessments, and regulatory filing commitments.\nManage one direct report initially, with responsibility for building and expanding the QC commercial team over the following year\nRequirements\nBachelors or MS in chemistry or biochemistry or related discipline with at least 8+ years of experience with 6+ years of industry experience within Quality Control.\nExperience supporting commercial GMP products is required.\nDemonstrated knowledge of USP, EP, JP, cGMP, ICH, data integrity, global market release expectations, and inspection readiness requirements for commercial QC operations.\nExpertise with commercial method transfer, validation maintenance, verification, performance monitoring, and troubleshooting across contract testing laboratories and manufacturing partners.\nExperience supporting commercial stability programs, including shelf-life support, data trending, protocol governance, annual commitments, and post-approval stability requirements.\nInvolvement with commercial specification implementation, justification, market-specific requirements, lifecycle management, post-approval revisions, and change implementation.\nHighly collaborative team player with strong communication skills and the ability to drive internal and external commercial execution.\nPrior experience managing and developing people; track record of building high performing teams\nAbility to prioritize responsibilities and multi-task in a fast-paced environment with changing priorities \nWork Location and Conditions\nAt Amylyx, we proudly support remote work opportunities within the United States. However, due to business considerations related to health insurance coverage and state tax regulations, we are unable to hire employees who reside and/or work in certain states. Currently, we are not considering applicants from Alaska, Arizona, Hawaii, Michigan and Tennessee.\nYou will be expected to travel to our corporate location in Cambridge, MA several times a year and attend other company-related events as necessary and requested.\nYou must have access to work in setting which enables meeting all requirements of the role (including privacy, reliable internet access, phone, ability to video conference, etc.) at your remote location.\nCompensation\nThe pay range posted below represents our good faith estimate of compensation for this role, based on market data and internal benchmarks. The final offer may vary depending on a candidate’s experience, skills, and qualifications, as well as considerations of internal equity.\nEstimated Pay Range\n$171,000—$192,000 USD\nTo stay connected with us, follow Amylyx Pharmaceuticals on LinkedIn.\nTo return to our website please click here.\nAmylyx Pharmaceuticals is an Equal Opportunity Employer that does not discriminate on the basis of actual or perceived race, color, creed, religion, national origin, ancestry, citizenship status, age, sex or gender (including pregnancy, childbirth, pregnancy-related conditions, and lactation), gender identity or expression (including transgender status), sexual orientation, marital status, military service and veteran status, physical or mental disability, genetic information, or any other characteristic protected by applicable federal, state, or local laws and ordinances. Amylyx’s management team is dedicated to this policy with respect to recruitment, hiring, placement, promotion, transfer, training, compensation, benefits, employee activities, access to facilities and programs, and general treatment during employment. Accommodations are available for candidates who require them in our selection process. If you need an accommodation, please let your Amylyx Talent Acquisition contact know.\nIt is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. 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