Sign up to access all features of our service.
  • Job search
  • Favorites
  • Create a CV
    New
  • Salaries
  • Subscriptions

Remote Associate Director, Quality Operations (GMP/CMC QA)

Amylyx Pharmaceuticals, Inc.

Cambridge, MA
  • Remote job

Amylyx Pharmaceuticals, Inc. is seeking an Associate Director, Quality Operations to provide end-to-end quality oversight of clinical and development manufacturing processes. You will lead QA activities across production, testing, labeling, packaging, and distribution for non-commercial programs, ensuring compliance with GMP/GDP standards. The role involves authoring and reviewing IND CMC submissions, managing quality systems, supporting regulatory inspections, and collaborating with internal #J-18808-Ljbffr Amylyx Pharmaceuticals, Inc.

Vacancy posted 4 days ago
Similar jobs that could be interesting for youBased on the Remote Associate Director, Quality Operations (GMP/CMC QA) in Cambridge, MA vacancy
  • $160k - $200k

     ...is seeking an experienced Associate Director, GMP Quality Assurance Operations to be a key leader within...  ...in the office, and 1 day remote.Responsibilities (...  ...to):Lead and execute GMP QA activities for development...  ...closurePartner closely with CMC, Technical Operations, Analytical... 
    Remote work
    Work at office

    Kiniksa Pharmaceuticals

    Lexington, MA
    3 days ago
  • $175k - $225k

    Position: Associate Director, Quality Assurance - CMC Operations Location: Newark, CAJob Id:...  ...responsible for leading and managing QA activities, oversight, and support to Protagonist’s CMC team with GMP manufacturing. This individual will... 
    Suggested
    Full time
    Temporary work
    Work at office
    Flexible hours

    Protagonist Therapeutics

    Newark, CA
    1 day ago
  • $172k - $194k

     ...responsible for providing CMC quality oversight of drug...  ...stages. As the GMP quality expert, this...  ...anticipate hiring the Associate Director, Quality Operations in September 2026....  ...materials. - Provide QA review and approval...  ...we proudly support remote work opportunities... 
    Remote work
    Full time
    Contract work
    Local area

    Amylyx Pharmaceuticals

    Cambridge, MA
    1 day ago
  • $150k - $195k

     ...6800 Technical Operations Location: San Diego, USA- Remote Be a part of a...  ...Position Summary The Associate Director, Technical...  ...for managing Quality Control activities...  ...with GMP and international...  ...in Analytical, CMC, Quality, and Regulatory...  ...Assurance (QA) PAI readiness... 
    Remote work
    Contract work
    Temporary work

    Travere Therapeutics

    Columbus, OH
    12 hours ago
  • $182.07k - $235.62k

     ...improving the lives of patients for generations to come. The Associate Director, Quality Assurance - GMP Operations provides senior Quality leadership and direct quality...  ...Practices (GLPs).Demonstrates in-depth knowledge of QA principles, concepts, industry practices, and... 
    Suggested
    Full time
    Contract work
    For contractors
    Local area

    GILEAD Sciences

    Foster, CA
    21 hours ago
  • Amylyx Pharmaceuticals is seeking an Associate Director, Quality Operations to oversee GMP quality across drug substance, drug product, and finished products in...  ...activities with contract partners. The position focuses on QA oversight of manufacturing, testing, labeling,... 
    Contract work

    Amylyx Pharmaceuticals

    Cambridge, MA
    4 days ago
  • $94.6k - $141.8k

    Job DescriptionGeneral Summary:The Associate Director, GMP Operational Quality Assurance is a Quality leader and advanced...  ...of complex quality initiatives and QA oversight of external manufacturing...  ...be designated as: 1. Hybrid: work remotely up to two days per week; or select2... 
    Remote work
    Full time
    Contract work
    Summer work
    Flexible hours
    2 days per week

    Vertex Pharmaceuticals

    Boston, MA
    4 days ago
  • $156.6k - $234.8k

     ...Job DescriptionGeneral Summary:The Associate Director, GMP Operational Quality is responsible for oversight of team...  ...manufacturing facilities. Manages QA On The Floor and QA Walkthrough programs...  ...be designated as: 1. Hybrid: work remotely up to two days per week; or select2... 
    Remote work
    Full time
    Work experience placement
    Summer work
    Flexible hours
    Day shift
    2 days per week

    Vertex Pharmaceuticals

    Boston, MA
    21 hours ago
  • $160k - $180k

     ...beyond.About the Role >>> Associate Director GMP QualityAs the Associate Director, GMP Quality, reporting to the Head...  ...functional teams such CMC, Regulatory and Supply...  ...and Stability reports Operational oversight of Olema’s...  ...GMP / GMP QA role Experience with small... 
    Work experience placement
    Work at office
    Flexible hours

    Olema Oncology

    San Francisco, CA
    4 days ago
  • $160k - $195k

     ...Facebook.Role Summary:The Associate Director, QA Operations serves as the QA technical...  ...continuous improvement of Quality Systems, procedures, policies, and metrics supporting GMP activities. Provides leadership...  ...programsCollaborates with CMC, Regulatory Affairs, and Project... 
    Contract work
    Work experience placement
    Local area
    Flexible hours

    Dyne Therapeutics

    Waltham, MA
    3 days ago
  • $150k - $195k

     ...patients.Position Summary:The Associate Director, Technical Operations (Small Molecule CMC) will provide technical...  ...partner closely with Quality, Regulatory Affairs,...  ...technical support for GMP quality management...  ...is expected to be 100% remote.Travere is an EEO/AA/Veteran... 
    Remote work
    Full time
    Contract work
    Temporary work

    Travere Therapeutics

    San Diego, CA
    4 days ago
  • $161k - $180k

     ...Associate Director, Quality Assurance Avenzo Therapeutics, Inc. ("Avenzo...  ...Practice (GMP) standards, regulatory...  ...Provide Quality Assurance (QA) oversight of contract...  ...Manufacturing, and Controls (CMC) teams and Contract...  ...Work Environment: Remote: Home office; expected... 
    Remote work
    Contract work
    Temporary work
    Work at office
    Local area
    Home office
    Monday to Thursday
    Flexible hours
    Night shift

    Avenzo Therapeutics

    United States
    4 days ago
  • $200k - $260k

     ...LinkedIn and X.   We are seeking a Director/Senior Director, GMP Quality Assurance Operations. You will be responsible for...  ...with growing supply demand. Lead QA input into CDMO selection,...  ...closure. Partner closely with CMC, Technical Operations, Analytical... 
    Contract work
    Temporary work
    Flexible hours

    Crescent Biopharma

    Waltham, MA
    15 days ago
  •  ...Pharmaceuticals is seeking a Manager, Quality Operations to provide GMP quality oversight of sterile drug product...  ...with GMP/GDP standards and leads QA activities across contracted partners...  ...readiness. The position supports NDA/CMC submissions, reviews batch records, and... 
    Remote job

    Amylyx Pharmaceuticals

    Cambridge, MA
    3 days ago
  • Olema Oncology is seeking an Associate Director, GMP Quality to oversee GMP activities for clinical and commercial products, including QA review of batch records and supplier compliance. This role partners with CMC, Regulatory and Supply Chain, and will be based in SF or... 

    Olema Oncology

    Cambridge, MA
    12 hours ago
  • Job DescriptionGeneral Summary:The Associate Director, CMC Quality Compliance and Inspection Readiness,...  ...and compliance programs for external operations. Works cross-functionally and cross-...  ...choose to be designated as: Hybrid: work remotely up to two days per week; or selectOn... 
    Remote work
    Full time
    Summer work
    Flexible hours
    2 days per week

    Vertex Pharmaceuticals

    Boston, MA
    2 days ago
  • $150k - $195k

     ...patients.Position Summary:The Associate Director, Quality Assurance - Technical, is...  ...activities as needed.Support QA and Travere Senior Management...  .... Direct experience in GMP Quality Assurance, Analytical...  ...role is expected to be 100% remote.Total Rewards Offerings:Travere... 
    Remote work
    Full time
    Contract work
    Temporary work
    Interim role

    Travere Therapeutics

    San Diego, CA
    2 days ago
  • $156k - $220k

     ...experienced and driven Associate Director of Global Quality to provide hands‑on...  ...ingredient (API) operations. This role carries accountability...  ...in ICH guidelines, GMP regulations, and the...  ...may be hybrid or remote, with preference for...  ...quality sections, CMC data, and site... 
    Remote work
    Full time
    Contract work
    Part time
    Local area

    Antheia, Inc.

    Edison, CA
    2 days ago
  •  ...corporate, and commercial operations. About the Role:...  ...Senior Manager/Associate Director, Quality Control to lead Quality...  ...control checks on the CMC sections of regulatory...  ...In collaboration with QA, manage internal...  ...CMOs, participate in remote audits, and perform on... 
    Remote work
    Full time
    Temporary work
    Work at office
    2 days per week

    Xenon Pharmaceuticals

    Needham, MA
    1 day ago
  • Travere Therapeutics in San Diego, CA is seeking an Associate Director, Technical Operations (Small Molecule CMC) to provide technical oversight of API development...  ...with Travere CDMOs. This role partners with Quality, Regulatory Affairs, Clinical, and Supply Chain to... 
    Remote job

    Travere Therapeutics

    Columbus, OH
    1 day ago
  • $157.2k - $298.8k

     ...businesses, world-class operations and investments in...  ...an open position as the Quality Assurance Manager for the...  ...products and services. The QA Manager partners...  ...relevant experience; OR Associate’s degree / Technical School...  ...as on-site, hybrid or remote.The salary range for this... 
    Remote work
    Temporary work
    Work experience placement
    Work at office
    Flexible hours

    Raytheon

    East Hartford, CT
    2 days ago
  • $153.9k - $230.9k

     ...DescriptionGeneral/Position SummaryThe Associate Director - Shift Quality Operationsis an advanced technical...  ...and oversight for manufacturing operations conducted across assigned shifts for...  ...ResponsibilitiesQuality OversightProvide shift-based QA oversight for aseptic manufacturing... 
    Full time
    Summer work
    Flexible hours
    Shift work

    Vertex Pharmaceuticals

    Boston, MA
    4 days ago
  • Olema Oncology is seeking an Associate Director, GMP Quality to oversee GMP activities for clinical and commercial...  ...The role requires collaboration with CMC, Regulatory, and Supply Chain...  ...strong background in FDA-regulated GMP QA, NDA/BLA submissions, and quality systems... 

    Olema Oncology

    San Francisco, CA
    2 days ago
  • $164k - $200.75k

     ...metabolic dysfunction-associated steatohepatitis (MASH)...  ...scientific excellence, operational rigor, and...  ...in the right way.Leads Quality change control governance...  ...expectations. Partners with CMC / MSAT, Supply Chain,...  ...or related)10-12 years GMP QA / QMS with change control... 
    Minimum wage
    Full time
    Local area
    Flexible hours

    Madrigal Pharmaceuticals

    Conshohocken, PA
    3 days ago
  • $212.15k - $240k

     ...targets.Position OverviewThe Director, Quality Operations will report to the Senior...  ...controls, deviations, and other GMP-related processes are...  ...external documentation related to QA operations. Regulatory...  ...needed. Assist in updating CMC sections of regulatory and quality... 

    Immunome

    Bothell, WA
    1 day ago
  • $153.6k - $230.4k

     ...another applicable GMP guidelines and internal...  ...to identify QA risks at CMO's and...  ...Supports technically the operational activities which...  ...Responsible for working with Quality Leaders in each...  ...Affairs - CMC, Pharmacovigilance,...  ...approval of documents associated with validation or... 
    Contract work

    Daiichi Sankyo

    Basking Ridge, NJ
    2 days ago
  • $150k - $195k

     ...staffingfuture.comPosition Summary:The Associate Director, Technical Operations - Drug Product, is responsible...  ...in Technical Operations, Quality, Regulatory CMC, Clinical, and Supply Chain. This...  ...support for quality systems governing GMP manufacturing including deviations... 
    Remote work
    Work experience placement

    Planet Pharma

    San Diego, CA
    2 days ago
  • $164.5k - $222.5k

    Associate Director, Early Development Quality Lead, R&D QAOverview The Early Development Quality Lead is responsible for the strategic quality oversight of...  ...located within the US and can be hybrid, onsite, or remote. Key ResponsibilitiesSets the strategic quality oversight... 
    Remote work
    Full time
    Temporary work
    Work experience placement
    Local area
    Flexible hours

    Alnylam Pharmaceuticals

    Cambridge, MA
    4 days ago
  •  ...is seeking a highly experienced leader for the Quality team to drive gRNA, mRNA, and LNP analytical methodologies and GMP testing. This role partners with Research, Process...  ...‑vivo gene medicines and to shape the program CMC strategy. The candidate will lead cross‑... 

    Editas Medicine

    Cambridge, MA
    2 days ago
  •  ...Title: Associate Director, Quality Operations – Lab QA Location: Flexible, US If you are interested in the below position...  ...of Lab QA, Manufacturing QA, and GMP/GDP Compliance functions, and this...  ...responsible for supporting all Biologics CMC programs in compliance with... 
    Contract work
    Flexible hours

    TG Therapeutics Inc

    Raleigh, NC
    2 days ago

Do you want to receive more vacancies?

Subscribe and receive similar vacancies to Remote Associate Director, Quality Operations (GMP/CMC QA). Be the first to apply!