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

Associate Director, CMC Quality & Inspection Readiness

Vertex Pharmaceuticals Inc (US)

Vertex Pharmaceuticals Inc. seeks an Associate Director, CMC Quality Compliance and Inspection Readiness in Boston. You will own inspection readiness for external sites, drive continuous improvement of quality programs, and lead cross-functional teams to address risks and CAPAs. The role emphasizes collaboration with operations and external sites, regulatory knowledge, and Lean/six sigma experience, with hybrid-eligible work arrangements and travel up to 20% internationally. #J-18808-Ljbffr Vertex Pharmaceuticals Inc (US)

Vacancy posted 4 days ago
Similar jobs that could be interesting for youBased on the Associate Director, CMC Quality & Inspection Readiness in Boston, MA vacancy
  • Job DescriptionGeneral Summary:The Associate Director, CMC Quality Compliance and Inspection Readiness, is responsible for inspection readiness and compliance of external sites including evaluating, improving, and monitoring commercial level quality compliance and quality... 
    Suggested
    Full time
    Summer work
    Remote work
    Flexible hours
    2 days per week

    Vertex Pharmaceuticals

    Boston, MA
    4 days ago
  • Amylyx Pharmaceuticals, Inc. is seeking an Associate Director, Quality Operations to provide end-to-end quality...  ...involves authoring and reviewing IND CMC submissions, managing quality systems, supporting regulatory inspections, and collaborating with internal #J-1880... 
    Suggested
    Remote job

    Amylyx Pharmaceuticals, Inc.

    Cambridge, MA
    1 day ago
  • $160k - $180k

    Associate Director GMP Quality Reporting to the Head of GMP Quality, you will oversee...  ...You will collaborate with CMC, Regulatory, and Supply...  ...during internal and regulatory inspections. This role will be based...  ...pre‑approval inspection readiness for NDA/commercial launch... 
    Suggested
    Work experience placement
    Work at office
    Flexible hours

    Olema Oncology

    Boston, MA
    4 days ago
  • $172k - $194k

     ...assembled an experienced team ready to take action because the...  ...responsible for providing CMC quality oversight of drug substance...  ...We anticipate hiring the Associate Director, Quality Operations in September...  ...or other regulatory agency inspections. Required Qualifications... 
    Suggested
    Contract work
    Local area
    Remote work

    Amylyx Pharmaceuticals, Inc.

    Cambridge, MA
    1 day ago
  • Job DescriptionGeneral Summary:The CMC Quality Compliance Director is responsible for inspection readiness and compliance of internal and external sites including evaluating...  ...and compliance including processes and associated governance across all GMP areas. This position... 
    Suggested
    Full time
    Work experience placement
    Summer work
    Remote 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 activities, development of personnel...  ...with study teams and functions for proactive inspection readiness across assigned programs.Provides inspection support... 
    Full time
    Work experience placement
    Summer work
    Remote work
    Flexible hours
    Day shift
    2 days per week

    Vertex Pharmaceuticals

    Boston, MA
    2 days ago
  • Vertex Pharmaceuticals Incorporated is seeking a CMC Quality Compliance Director to lead inspection readiness and drive global quality governance across GMP areas. You will shape strategies, partner with cross-functional teams, and ensure scalable programs for current... 

    Vertex Pharmaceuticals Incorporated

    Boston, MA
    4 days ago
  • $153.9k - $230.9k

     ...DescriptionGeneral/Position SummaryThe Associate Director - Shift Quality Operationsis an advanced technical...  ..., including formulation, filling, inspection, and supporting activities as...  ...appropriately.Support batch disposition readiness through review of manufacturing... 
    Full time
    Summer work
    Flexible hours
    Shift work

    Vertex Pharmaceuticals

    Boston, MA
    1 day ago
  • $180k - $195k

     ...and key opinion leaders. For more information, please visit Reporting to the Head of Quality, Seaport Therapeutics is seeking an experienced Associate Director, Quality Assurance CMC to manage GMP quality assurance activities supporting clinical development programs,... 

    Seaport Therapeutics

    Boston, MA
    3 days ago
  • Join to apply for the Associate Director, R&D Quality role at BioSpace We are seeking a highly motivated and experienced Associate Director...  ...follow‑through. The successful candidate will strengthen inspection readiness, harmonize processes and job aids, and enable data‑... 
    Work from home

    BioSpace

    Cambridge, MA
    2 days ago
  • $90k - $115k

    Associate Director, Global Quality (R&D) Pay Range: $90,000.00 - $115,000.00 per year Travel may be required. We are partnered with a biotechnology...  ...international regulatory standards while driving inspection readiness, vendor oversight, proactive risk governance, and... 
    Work experience placement
    Remote work
    Worldwide
    Shift work

    Skills Alliance Enterprise

    Cambridge, MA
    2 days ago
  • $200k - $217k

     ...experienced, strategic, and hands-on Associate Director, GMP Quality Drug Product to serve as the end-to...  ...successful qualification, audit readiness, manufacturing oversight, and quality...  ...systems, support global regulatory inspections and submissions, drive continuous compliance... 
    Full time
    Contract work
    For contractors

    Celea Therapeutics

    Boston, MA
    6 days ago
  • $160.6k - $240.8k

    Job DescriptionGeneral Summary:The Clinical Study Quality Lead (SQL), Associate Director is responsible for advanced quality assurance oversight...  ...action plans to mitigate risks, real-time study inspection readiness oversight, and collaboratively identifying and driving... 
    Full time
    Work experience placement
    Summer work
    Work at office
    Remote work
    Flexible hours
    2 days per week

    Vertex Pharmaceuticals

    Boston, MA
    2 days ago
  •  ...leading healthcare solutions provider is seeking an Associate Director, Clinical Program Quality Leader in Cambridge, MA. The candidate will provide...  ...oversight for clinical research programs, ensuring inspection readiness and GCP compliance. A minimum of 10 years in the... 
    Hourly pay

    US Tech Solutions

    Cambridge, MA
    2 days ago
  • $142.5k - $256.5k

    The RoleThe Associate Director, Quality Control Lab Automation Strategy & Digital Integration is responsible...  ...This includes supporting regulatory inspections, overseeing automation related...  ...value, compliance impact, technical readiness, resource capacity, and long-term... 
    Permanent employment
    Full time
    Work at office
    Work from home

    Moderna Therapeutics

    Norwood, MA
    16 hours ago
  • $160k - $195k

     ...follow us on X, LinkedIn and Facebook.Role Summary:The Associate Director, Quality Management Systems is a key member of the quality team responsible...  ...management and training ensuring these systems are inspection-ready, risk-based, and aligned with global regulatory... 
    Local area

    Dyne Therapeutics

    Waltham, MA
    4 days ago
  • $120 - $170 per hour

    Associate Director, Clinical Program Quality Leader Base pay range: $120.00/hr - $170.00/hr Location: Cambridge, MA (Hybrid - 2 days onsite in a week...  ...Development (MPD) with the overall goal of inspection readiness. Serves as a Strategic Quality Thought Partner to... 
    Temporary work
    For contractors
    Work at office
    Immediate start
    Night shift
    2 days per week

    US Tech Solutions

    Cambridge, MA
    2 days ago
  • Alnylam Pharmaceuticals seeks an Associate Director of Digital Quality Compliance to own and advance Quality digital capabilities. You will oversee...  ...lead cross-functional governance forums to enable inspection readiness and continuous #J-18808-Ljbffr Alnylam... 

    Alnylam Pharmaceuticals

    Cambridge, MA
    4 days ago
  •  ...Responsibilities: The Associate Director, Regulatory Affairs CMC will be responsible for...  ...documents for submission-readiness, to ensure that all...  ...guidelines. Ensures high-quality and on-time submissions,...  .... Support regulatory inspections and audits Navigate the... 

    Anagram Therapeutics, Inc.

    Natick, MA
    21 hours ago
  •  ...Job Description Job Description Description: The Director/Associate Director, Quality Management Systems, reporting directly to the Senior Director...  ...responsibilities. Ensuring these systems are inspection-ready, risk-based, and aligned with global regulatory expectations... 
    Work experience placement
    Work at office
    Remote work
    Night shift

    Corbus Pharmaceuticals Inc

    Norwood, MA
    7 days ago
  • $155k - $214k

    About This Role:As the Associate Director, Global Quality Risk Management, you will be at the forefront of Biogen’s commitment to quality excellence...  ...forums.Prepare materials for health authority inspections and external audits pertaining to risk-based decisions.... 
    Full time
    Temporary work
    Local area

    Biogen Idec

    Cambridge, MA
    2 days ago
  • $190k - $230k

     ...Job Description Job Description Associate Director/Director, Technical Quality – Solid Biosciences Charlestown, MA or Remote (US) Solid Biosciences...  ...into actions required for improvement. Act as an inspection lead and/or liaison for regulatory inspections... 
    Temporary work
    Remote work
    Flexible hours

    Solid Biosciences

    Charlestown, MA
    7 days ago
  • $213.6k - $320.4k

     ...DescriptionPosition Summary:The Senior Director, Global Quality Systems holds a pivotal...  ...for evolution ensuring readiness and sustainability for...  ...into operating standards, inspection readiness, compliance and excellenceLead...  ...preclinical, clinical, and CMC processes, with... 
    Full time
    Contract work
    Work experience placement
    Summer work
    Remote work
    Flexible hours
    2 days per week

    Vertex Pharmaceuticals

    Boston, MA
    2 days ago
  • $142.5k - $256.5k

     ...industry.Reporting to the Director, Regulatory...  ...Management (RIM), the Associate Director, Regulatory...  ...Regulatory Operations, CMC, Labeling, Quality, Enterprise Data,...  ...capabilities.Lead business readiness activities...  ...data integrity and inspection readiness.Serve as the... 
    Permanent employment
    Full time
    For contractors
    Work at office
    Work from home

    Moderna Therapeutics

    Cambridge, MA
    3 days ago
  • $153.6k - $241.34k

    Associate Director, Clinical & Quality Process Compliance Location: Cambridge, MA - Hybrid (not remote). Relocation benefit available. Job Description...  ...audit program, hosting or leading regulatory inspections, investigations, and remediation activities on a global... 
    Temporary work
    Local area
    Relocation package

    BioSpace

    Boston, MA
    2 days ago
  •  ...Position Summary The Associate Director, Medical Safety is responsible...  ...Biostatistics, and Manufacturing/Quality. Responsibilities...  ...coordination with Clinical and CMC/Manufacturing teams...  ...UPESI handling Support inspection readiness and participate in internal... 
    Full time
    Work at office
    Remote work

    CRISPR Therapeutics

    Boston, MA
    3 days ago
  • $136.51k - $204.77k

     ...Job Title: Associate Director, CMC Lead Introduction to role: Are you ready to lead early-stage CMC strategy that turns precision radioconjugate science into...  ...strategy; guide and contribute to authoring high-quality documentation and data packages for IND/IMPD submissions... 
    Hourly pay
    Temporary work
    Boston, MA
    17 days ago
  • $155.4k - $233k

    ## Program Quality Associate Director, AssuranceApplylocations: Boston, MAtime type: Full timeposted on: Posted Todaytime...  ...closure of CAPAs* Support organizational readiness for internal, external, and regulatory inspections or assessments* Collaborate with the Director... 
    Summer work
    Remote work
    Flexible hours
    2 days per week

    Jobleads-US

    Boston, MA
    3 days ago
  • $94.6k - $141.8k

    Job DescriptionGeneral Summary:The Associate Director, GMP Operational Quality Assurance is a Quality leader and advanced technical resource responsible...  ...alignment with current regulatory expectationsDrive Quality readiness for major development milestones including IND/IMPD... 
    Full time
    Contract work
    Summer work
    Remote work
    Flexible hours
    2 days per week

    Vertex Pharmaceuticals

    Boston, MA
    1 day ago
  • Responsibilities: Define and execute the IT solutions roadmap for CMC digital transformation. Oversee implementation and lifecycle...  ...Ensure GxP/data integrity/global regulatory compliance and audit readiness. Drive operational excellence for CMC systems (e.g., Empower, SoftMax... 
    Flexible hours

    Alnylam Pharmaceuticals

    Cambridge, MA
    16 hours ago

Do you want to receive more vacancies?

Subscribe and receive similar vacancies to Associate Director, CMC Quality & Inspection Readiness. Be the first to apply!