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 Incorporated

Vertex Pharmaceuticals Incorporated is seeking an Associate Director to lead CMC Quality Compliance and Inspection Readiness. You will drive inspection readiness for external operations, collaborate across functions, and guide risk assessments and CAPA closures to sustain quality excellence. The role requires a scientific degree and 8+ years of experience, with travel up to 10–20% and a hybrid work arrangement allowing remote or on-site days. #J-18808-Ljbffr Vertex Pharmaceuticals Incorporated

Vacancy posted 5 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
    14 hours ago
  • 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... 
    Suggested

    Vertex Pharmaceuticals Inc (US)

    Boston, MA
    5 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
    2 days ago
  •  ...seeking an experienced Senior Manager/Associate Director, Quality Control to lead Quality Control...  ...quality control checks on the CMC sections of regulatory submissions...  ...external laboratories, FDA/EMA inspections, and inspection readiness is preferred. Strong experience... 
    Suggested
    Temporary work
    Work at office
    Remote work
    2 days per week

    Xenon Pharmaceuticals Inc.

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

     ...every single day. If you’re ready to be part of a tenacious,...  ...beyond About the Role As the Associate Director, GMP Quality , reporting to the Head of...  ...functional teams such CMC, Regulatory and Supply Chain...  ...necessary Support Pre-Approval Inspection readiness for NDA /... 
    Suggested
    Work experience placement
    Work at office
    Flexible hours

    Olema Oncology

    Cambridge, 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... 
    Contract work
    Local area
    Remote work

    Amylyx Pharmaceuticals

    Cambridge, MA
    2 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
    3 days 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... 
    Full time
    Work experience placement
    Summer work
    Remote work
    Flexible hours
    2 days per week

    Vertex Pharmaceuticals

    Boston, MA
    14 hours 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
    5 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
    2 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
    3 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
    3 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
    3 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
    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
    3 days 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
    14 hours 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
    1 day ago
  •  ...The Associate Director of Regulatory Affairs CMC will be responsible for developing, implementing and advising on...  ...global basis. During health authority inspections, the Associate Director of...  ...President of Regulatory Affairs and Quality Assurance and is located in Cambridge... 

    Voyager Therapeutics, Inc.

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

    Anagram Therapeutics, Inc.

    Natick, MA
    2 days ago
  • The Director/Associate Director, Quality Management Systems, reporting directly to the Senior Director, Head of Quality, will be responsible for...  ...Management responsibilities. Ensuring these systems are inspection-ready, risk-based, and aligned with global regulatory... 
    Work experience placement
    Work at office
    Night shift

    Corbus Pharmaceuticals

    Norwood, MA
    5 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
    3 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
    3 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
    14 hours 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
    3 days ago
  • $160k - $240k

     ...Opportunity Overview As an Associate Director, Device Development, you...  ...of device strategy across CMC, regulatory, clinical, and...  ...interaction challenges Quality, Risk & Regulatory Own Design...  ...and ensure compliance and inspection readiness Serve as SME for design... 
    Work at office

    Rhythm Pharmaceuticals

    Boston, MA
    2 days ago
  • $195k - $330k

     ...impact:Drive end-to-end CMC program management for...  ...product, analytical, quality, regulatory, and...  ...transfer, and commercial readiness activities for oral solid...  ...CMC experience; Sr. Director level requires commensurate...  .../GLP compliance, and inspection readiness.Proven... 

    Kymera Therapeutics

    Watertown, MA
    1 day 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
    23 days ago
  • $140k - $210k

    Associate Director, Regulatory Starting Material Description...  ...the Vice President, CMC, this role will serve...  ...commercial manufacturing readiness. This individual will...  ...Regulatory Affairs, Quality, and external...  ...expertise during regulatory inspections and audits related to... 
    Full time
    Contract work
    For contractors
    For subcontractor
    Work at office

    Centessa Pharmaceuticals

    Boston, MA
    3 days ago
  •  ...Manager Clinical Trial (open to Associate Director level) About Draig...  ..., regulatory, and internal quality standards. As a core member...  ...regulatory, safety, biostats, CMC, commercial) to design and...  ...quality, data integrity, and inspection readiness. Proven leadership and stakeholder... 

    Draig Therapeutics

    Boston, MA
    1 day 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!