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

Global CAPA & Deviations Manager - Quality Systems

Integrated Resources Inc

A specialized healthcare solutions provider located in Lexington, MA is seeking an experienced Deviations/CAPA Manager. The role involves managing global event management processes and ensuring compliance with GMP regulations. Ideal candidates will have at least 5 years of quality experience, a Bachelor’s degree in a science field, and ASQ certification. This position demands strong expertise in deviation systems and a collaborative approach across teams. #J-18808-Ljbffr

Vacancy posted 12 hours ago
Similar jobs that could be interesting for youBased on the Global CAPA & Deviations Manager - Quality Systems in Lexington, MA vacancy
  •  ...Deviations/CAPA Manager Quality Systems IV Contract Integrated Resources, Inc., is led by a seasoned team with combined decades in the industry. We deliver...  ...and steadily grow. About Client: Client is the leading global biotechnology company focused on serving people with... 
    Suggested
    Contract work

    Integrated Resources

    Lexington, MA
    11 hours ago
  •  ...Scholar Rock is a late-stage global biopharmaceutical company...  ...and motivated Director of Quality Systems and GxP Compliance. Reporting...  ...Support global Quality Management System (QMS) transition from...  ...processes (change control, deviations, CAPAs, complaints, audits, document... 
    Suggested

    Scholar Rock

    Cambridge, MA
    2 days ago
  • $130k - $150k

     ...Description We are looking for an experienced Quality Assurance professional to join our team as Manager, Quality Systems supporting our novel target identification...  ...audit activities. Assist in managing Deviation, CAPA, Change Control programs as needed. Assist... 
    Suggested
    Work at office
    Local area
    Flexible hours

    TScan Therapeutics

    Waltham, MA
    10 days ago
  • $122k - $150k

     ...and experiences to join our team. What You’ll Do: The Manager of GxP Quality Systems will support Quality Management System processes,...  ...Responsibilities: Track and support closure of Quality Events (e.g., Deviations, CAPAs, etc.) Support management of GxP training program,... 
    Suggested
    Full time
    Local area
    Flexible hours
    3 days per week

    Kailera Therapeutics, Inc.

    Waltham, MA
    2 days ago
  •  ...patients’ lives. About the role The Manager, Quality Systems is a hands‑on, execution‑focused...  ...and core QMS workflows, including Deviation Management, CAPA, Product Quality Complaints, Change...  ...systems. Maintain compliance with global regulatory expectations including FDA... 
    Suggested
    Work at office
    Local area

    Zevra Therapeutics, Inc.

    Boston, MA
    11 hours ago
  • $125k - $155k

     ...execution. What's the opportunity? The Quality Systems Manager at Parabilis Medicines is responsible for...  ...Quality Events: Manage workflows related to CAPAs (Corrective and Preventive Actions), Change Controls and Deviations and Investigations. Inspection Readiness... 
    Remote work
    Shift work

    Parabilis Medicines

    Cambridge, MA
    11 days ago
  • $186.49k - $278.88k

     ...The Director, Global Product Quality, GMP Processes is a strategic leadership role responsible...  ...role ensures that product quality systems are aligned with Good...  ...related to product quality complaints, deviations, CAPA, and management reporting , ensuring timely and effective... 
    Temporary work
    Work at office
    Local area
    Flexible hours

    Otsuka America Pharmaceutical Inc.

    Boston, MA
    4 days ago
  •  ...Zenas is a clinical-stage global biopharmaceutical...  ...Sr. Director of Global Quality Assurance, Clinical Development...  ...including conducting, managing, and overseeing audits,...  ..., investigations, and CAPA's. Conduct on-site,...  ...key Quality Management System (QMS) programs,... 
    Remote work

    Zenas BioPharma

    Waltham, MA
    3 days ago
  • $115k - $145k

     ...Role Overview & Key Functions: Provide management-level leadership, business process ownership, Veeva Quality Suite system administration support, policy development...  ...processes and enabling Veeva workflows, including deviations, CAPA, change control, controlled documents,... 
    For contractors

    Unavailable

    Newton, MA
    1 day ago
  • $130k - $150k

     ...JOB SUMMARY The Quality Control Technical Services (QCTS) team manages the lifecycle of analytical...  ..., and computer systems validation. The Manager...  ...Quality Agreements and global regulatory expectations...  ...documentation including deviations, CAPAs, and change controls related... 
    Live in
    Immediate start
    Visa sponsorship

    Genezen

    Lexington, MA
    18 days ago
  • $196k - $230k

     ...Role Summary The Director, Quality Management Systems is a quality leader responsible for designing, scaling, and advancing a global Quality Management System (QMS) that supports Dyne...  ...Identifiessystemic quality risks and ensurestimely CAPA development, closure, and effectiveness... 
    Local area

    Dyne Tx

    Waltham, MA
    11 hours ago
  •  ...to the Director, Quality Assurance, the Quality...  ...Compliance Manager is responsible for...  ...management, quality system performance, and operational...  ...cGMP, GxP, and global regulatory...  ...root cause analysis, CAPA development, trending...  ..., including deviations, change controls,... 
    Temporary work
    Work at office
    Local area
    Immediate start
    Remote work
    3 days per week

    Viridian Therapeutics, Inc.

    Waltham, MA
    3 days ago
  • $110k - $165k

     ...Overview Rhythm is a global, commercial-stage...  ...Rhythm is looking for a Manager Quality Assurance (QA) to play...  ...regulated quality management systems, including document...  ..., change control, deviations/complaints, and corrective...  ...preventative actions (CAPAs). Facilitates the... 
    Contract work
    Work at office

    Rhythm Pharmaceuticals

    Boston, MA
    21 days ago
  • $143k - $175k

     ...Senior Manager, Global Supply Chain Waltham, Massachusetts At Kailera, we are bold, authentic...  ...Assist with change controls and deviations as needed Support temperature excursion...  ...as required Support the IRT System Leads as necessary with regards to user... 
    Full time
    Local area
    Flexible hours
    3 days per week

    Kailera Therapeutics

    Waltham, MA
    2 days ago
  • Looking for a GCP Quality expert to work on implementing...  ...documentation, and management of GCP quality events, including deviations, potential serious breaches, CAPAs, change actions,...  ...and commercial systems supporting GCP compliance with US and global regulations (FDA,... 

    Monte Rosa Therapeutics

    Boston, MA
    4 days ago
  • $124.63k - $179.22k

     ...The Manager/Sr. Manager Training & Quality Systems will report to the Director Quality Systems and be responsible for the GxP Quality Training program at Eyepoint. This position will require the ability to build strong relationships with partner groups who support GLP... 

    Initial Therapeutics, Inc.

    Watertown, MA
    11 hours ago
  • $270k - $300k

     ...Senior Director, R&D Quality (GCP–GLP–GvP) is a key...  ...appropriate compliance with global GxP regulations,...  ..., quality agreements, CAPA management, and ongoing performance...  ...through a robust deviation and CAPA management process...  ...of clinical data systems and platforms (e.g., EDC... 
    Contract work
    Temporary work
    Work at office
    Local area
    Flexible hours

    Crescent Biopharma

    Waltham, MA
    9 days ago
  •  ...in providing unique, accessible, and high-quality medications, Azurity leverages its...  ...description: Job Type: Full-Time The Manager, Documentation Management plays a leadership...  ...and inspection-ready Quality Management System (QMS) within a regulated pharmaceutical environment... 
    Full time
    Live in
    Work at office
    Work from home

    Azurity Pharmaceuticals - US

    Woburn, MA
    18 days ago
  • $170k - $180k

     ...SUMMARY The Senior Manager, QA Computer System Validation (CSV) is responsible...  ...in accordance with global regulatory requirements,...  ...management, periodic review, deviation management, and CAPA. * Drive the shift from...  ...patient safety, product quality, and data integrity. *... 
    Full time
    Work at office
    Flexible hours
    Shift work
    3 days per week

    bluebird bio

    Somerville, MA
    3 days ago
  • $145k - $195k

     ...office. SUMMARY Manage Quality Approval (qualification)...  ...and lead investigations, deviations, change controls, and CAPAs, especially those involving...  ...custody / chain-of-identity systems Strong...  ...influence skills to support global, cross-functional clinical... 
    Full time
    Work at office
    Flexible hours
    3 days per week

    Genetix Biotherapeutics

    Somerville, MA
    1 day ago
  •  ...The Quality Manager/Senior Quality Manager is responsible for all aspects...  ..., change control, NCRs and CAPAs / SCARs, and ensuring compliance...  ...and maintenance of Quality Systems and documentation, including...  ...and quality management (deviations, NCR, Change control etc.) of... 
    Contract work
    Work experience placement
    Work at office
    Local area
    2 days per week

    scPharmaceuticals

    Burlington, MA
    12 hours ago
  •  ...Manager of Quality Assurance Summary: The Manager of Quality Assurance...  ...function and a quality management system which supports clinical...  ...and disposition. Manage Deviation and Change Control programs....  ...Corrective and Preventive Action ("CAPA") activities and processes.... 
    Temporary work
    For contractors
    For subcontractor
    Flexible hours

    KMR Search Group

    Boston, MA
    5 days ago
  •  ...Title: Director, Site Quality (GLP) Division/...  ...operations, laboratory systems, and regulated study programs...  ...with the Quality Management System (QMS) for all things...  ...: Document control, CAPA, deviation management, change...  ...Documents, ICH E6 (GCP), and global regulatory... 

    Dash Bio

    Waltham, MA
    4 days ago
  • $186k - $200k

     ...process. Assoc. Director, Quality - Commercial...  ...executed in compliance with global regulatory...  ...etc.) Change Controls, Deviations, and CAPAs Ensure transfers align...  ...support GMP quality Systems, including deviations...  ...review, CPV, OOS/OOT management, and stability programs... 
    Work at office
    Remote work
    Worldwide

    Kiniksa Pharmaceuticals

    Lexington, MA
    11 hours ago
  • $213k - $240k

     ...Director, Clinical Quality Assurance...  ...and related quality systems supporting clinical...  ...inspection readiness for global health authority...  ...support for clinical deviations, protocol...  ...root cause analysis, CAPA development, effectiveness...  ..., trending, and management visibility for... 
    Remote work

    Oruka Therapeutics

    Waltham, MA
    2 days ago
  • $190k - $232.8k

     ...the central nervous system (CNS) to address...  ...Director, Clinical Quality Assurance leads GCP...  ...-based strategies; managing audits, inspections...  ...oversight; and ensuring global regulatory...  ...audits Oversee deviations, quality issues (QIs), CAPAs, effectiveness checks... 
    Local area
    Flexible hours

    Dyne Therapeutics Inc

    Waltham, MA
    5 days ago
  • $252k - $269k

     ...Clinical Quality Assurance Senior Leader This...  ...ensure compliance across global clinical trials....  ..., implements and manages risk-based quality systems, collaborates across...  ..., and ensure timely CAPA development and closure...  ...of site deviations, protocol noncompliance... 
    Full time
    Contract work
    Local area
    Worldwide
    Shift work

    Alkermes

    Waltham, MA
    2 days ago
  •  ...Scholar Rock is looking for a Director of Quality Systems and GxP Compliance in Cambridge, MA. This is a leadership role overseeing quality...  ...systems. The successful applicant will drive quality management initiatives to prepare for commercial operations while supporting... 

    Scholar Rock

    Cambridge, MA
    1 day ago
  • $107.2k - $160.8k

     ...experienced Validation Manger, Quality Assurance to join...  .... The Validation Manager, Quality Assurance is...  ...production equipment, utility systems, analytical...  ...activities comply with global regulatory requirements...  ..., protocols, reports, deviations, and change controls... 
    Flexible hours

    Mariana Oncology

    Watertown, MA
    5 days ago
  • $285k - $350k

     ...Role The Head of Quality Assurance is...  ...appropriate Quality systems and governance frameworks...  ...commercial product lifecycle management. The Head of Quality...  ...with applicable global regulations and to...  ...resolution of deviations, investigations, CAPAs, change controls, and... 
    Fixed term contract

    Treeline Biosciences

    Watertown, MA
    2 days ago

Do you want to receive more vacancies?

Subscribe and receive similar vacancies to Global CAPA & Deviations Manager - Quality Systems. Be the first to apply!