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Quality Control Stability Manager Jobs in Massachusetts

Borg Design Inc

Quality Control Manager

Hudson, MA · On-site

Role Description As a Quality Control Manager at Borg Design Inc., you will be responsible for overseeing the quality of all machined parts produced by our team. This role is based in Hudson, MA and ...

Borg Design Inc

Quality Control Manager

Hudson, MA · On-site

Role Description As a Quality Control Manager at Borg Design Inc., you will be responsible for overseeing the quality of all machined parts produced by our team. This role is based in Hudson, MA and ...

Summit Careers Inc.

Quality Control Manager

Pittsfield, MA · On-site

$80K - $110K/yr

Quality Control Manager Job Overview Pay : $80,000- $110,000 We are seeking an experienced Quality Control Manager to lead and manage all quality operations throughout the manufacturing process. This ...

TransMedics

Manager Quality Control

Andover, MA · On-site

Overall management of quality control activities; oversee the development and implementation of robust systems and procedures to ensure evaluation, measurement and improvement of processes. * Manage ...

TransMedics

Manager Quality Control

Andover, MA · On-site

Overall management of quality control activities; oversee the development and implementation of robust systems and procedures to ensure evaluation, measurement and improvement of processes. * Manage ...

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Infographic showing various Quality Control Stability Manager job openings in Massachusetts as of August 2026, with employment types broken down into 67% Full Time, 22% Contract, and 11% Nights. Highlights an 100% In-person job distribution.

Manager, Quality Control Operations

Kiniksa Pharmaceuticals

Lexington, MA • On-site

Other

This job post has expired 2 days ago. Applications are no longer accepted.

Job description

Reporting to the Associate Director, Quality Control Stability and Trending, the Manager, Quality Control Operations will be responsible for day-to-day oversight of routine batch testing at contract and internal Kiniksa testing laboratories. This individual will be responsible for sample management, data review, management of reference standards, critical reagents, certificate of analysis generation and delivery of QC results. This role will collaborate with internal/external, multidisciplinary teams and external partners. 

This role is based in our Lexington, MA office and requires employees to be onsite five days per week.

Responsibilities (including, but not limited to):

  • Support Kiniksa's Quality Control programs for commercial and late-stage clinical drug products, including combination products 
  • Responsible for GMP reference standards including leading the qualification, requalification and inventory management across all laboratories
  • Participate on analytical teams to proactively support GMP routine operations
  • Coordinate shipping and sample management for all routine testing activities
  • Partner with contract testing labs to support routine release testing activities and ensure on time delivery of all batch testing including in-process, drug substance and drug product testing
  • Drive the timely completion of Quality System records associated with sample testing to improve reliability of test methods, facilitate change, and evaluate and prevent exceptions (change control, deviations, and CAPAs)
  • Author, review and approve related QC protocols, reports, and data. 
  • Review and approve laboratory data and results, assuring their traceability and integrity 
  • Generate Certificates of Analysis for product release, and other certificates of GMP testing 
  • Coordinate testing of Kiniksa samples at intern/external testing laboratories
  • Review, approve stability data, protocols, and reports as needed
  • Assure availability of critical reagents and other essential materials 
  • Manage GMP reserve sample program 
  • Drive process improvements and ensure inspection readiness (ISO, GMP alignment) for area of responsibility
  • Manage SOW and contracts for areas of responsibility
  • Participate in budget, track KPI metrics and additional tasks as required.

Stand Out Skills for Impact:

  • Strong expertise in GMP Quality Control operations for biologics, overseeing batch release testing, sample management, and data review to ensure product quality and compliance
  • Proven ability to manage end-to-end laboratory operations, including reference standards, critical reagents, stability programs, and coordination with internal labs and external CMOs
  • Deep knowledge of quality systems and compliance (deviations, CAPAs, change control), driving data integrity, traceability, and continuous improvement in QC processes
  • Effective cross-functional collaborator skilled in partnering with contract labs and internal teams, ensuring on-time delivery of testing, KPI performance, and inspection readiness

Qualifications and Experience:

  • 5+ years experience in Quality Control in GMP setting.  Experience in biologics required
  • BS in analytical chemistry, microbiology or related life sciences field 
  • Experience in routine GMP QC operations including reference standard management and review/release of QC testing data
  • Knowledge of analytical methodologies common for biologics analysis in addition to compendial testing.
  • Proven ability to manage projects and work with cross-functional teams comprised of internal and/or external contacts, including CMOs
  • Demonstrated strong written and verbal communication skills
  • Proven mindset of proactive continuous improvement
  • Efficient independent worker with ability to focus and drive for results
  • Strong organizational skills and attention to detail
  • Ability to work in a fast paced-environment and to handle multiple tasks
  • Strong commitment to compliance and ethical standards
  • Proficient with Microsoft Office suite (i.e., Word, PowerPoint, Excel, Outlook, SharePoint, etc.)
  • Ability to travel up to [5%]

Apply