Director, Quality Control

Watertown, MA | Onsite

About the Role

The Director, Quality Control reports to the Senior Director, Quality (Watertown Site Quality Head) and is responsible for providing site-level Quality Control strategy and ensuring the successful operation of the Quality Control function at the Watertown (WTN) site. This role oversees raw material, stability, environmental monitoring (EM), in-process, and release testing programs. The ideal candidate is a hands-on, innovative leader with strong experience in QC laboratory operations within a GxP-regulated, fast-paced and customer focused manufacturing environment. This role directly manages a team of QC professionals.

Main Tasks & Responsibilities

  • Plan and oversee QC laboratory operations, including people management, team development, and ensuring client and manufacturing timelines are met while adhering to the defined QC budget.
  • Build, develop, and lead a team of QC analysts and scientists through effective planning, mentoring, directing, and coordination of GMP testing activities.
  • Schedule raw material, in-process, release, and stability testing to support the manufacturing schedule.
  • Coordinate outsourced laboratory testing and develop strategies to bring testing in-house when appropriate.
  • Serve as a subject matter expert in QC testing assays, including both traditional and molecular methodologies.
  • Interact with auditors, regulatory inspectors, and clients during site visits and tours.
  • Develop and maintain a comprehensive Environmental Monitoring (EM) and utilities monitoring and trending program.
  • Coordinate assay validation design and execution, including writing qualification protocols, coordinating execution, and authoring concise technical reports.
  • Maintain the integrity of laboratory work areas, including equipment maintenance and calibration, safety, and cleanliness in compliance with established Quality standards.
  • Communicate and enforce laboratory quality requirements to all personnel working in the laboratory and ensure compliance with GMP expectations.
  • Create, analyze, verify, and approve QC data, results, reports, and Certificates of Analysis (COAs).
  • Generate, revise, and review specifications, SOPs, and other QC laboratory and testing documentation.
  • Lead Out-of-Specification (OOS), Out-of-Trend (OOT), and Deviation investigations related to the QC laboratory and ensure effective corrective and preventive actions (CAPAs) are implemented.
  • Lead and facilitate onboarding, training, and ongoing competency development of QC analysts to ensure adherence to laboratory practices and GMP requirements.
  • Prepare and deliver performance reviews, coaching, and performance improvement plans where needed.
  • Lead the configuration and implementation of the site LIMS platform in partnership with IT and the broader Quality organization.
  • Partner with Quality Assurance, MSAT, Manufacturing, and Site Leadership to drive continuous improvement, inspection readiness, and right-first-time performance across QC operations.

Skills & Experience

  • B.S. or M.S. in a scientific discipline required; Ph.D. preferred.
  • Minimum of 12–15+ years of progressive Quality Control experience in biologics or GMP-regulated manufacturing environments.
  • Director- or Senior Manager-level leadership experience required, with direct people management responsibility.
  • Strong experience with cGMP and Quality Systems, including OOS investigations, deviations, change control, and CAPAs.
  • Experience with traditional microbiology techniques; anaerobic microbiology experience is a plus.
  • Strong experience with analytical and microbiological assay validation, method transfer, and lifecycle management.
  • Technical writing experience for investigations, protocols, reports, and regulatory-ready documentation.
  • Experience with Environmental Monitoring (EM), utilities monitoring, and contamination control programs.
  • Prior experience with LIMS implementation and use preferred.
  • Excellent written and verbal communication skills with the ability to interface effectively with clients, auditors, and cross-functional teams.
  • High attention to detail, strong organizational skills, and the ability to manage multiple priorities in a fast-paced environment.
  • Strong data analysis skills with the ability to generate metrics and drive corrective actions.
  • Demonstrated ability to foster teamwork, accountability, innovation, transparency, and continuous improvement.
  • Proven ability to manage timelines, coordinate work schedules, and drive operational excellence within a QC organization.

Base Salary Range: $190,000 – $225,000 annually

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