Recipharm
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
Company Overview Recipharm is a leading Contract Development and Manufacturing Organisation (CDMO) employing over 5,200 employees worldwide. Recipharm provides manufacturing services of pharmaceuticals in various dosage forms, including, sterile fill & finish, oral solid dosage and biologics; clinical trial material development and manufacturing services; and, pharmaceutical product development. Its biologics segment, ReciBioPharm, works with customers to develop and commercialise advanced therapy medicinal products (ATMPs): pre‑clinical to clinical and commercial development and manufacture for new biological modalities, encompassing technologies based on live viruses and viral vectors, live‑microbial biopharmaceutical products, nucleic acid‑based mRNA and plasmid DNA production. Recipharm manufactures several hundred different products for customers ranging from big pharma to smaller research and development companies. It operates development and manufacturing facilities in France, Germany, India, Israel, Italy, Portugal, Spain, Sweden and the US and is headquartered in Stockholm, Sweden.
#J-18808-Ljbffr
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
Company Overview Recipharm is a leading Contract Development and Manufacturing Organisation (CDMO) employing over 5,200 employees worldwide. Recipharm provides manufacturing services of pharmaceuticals in various dosage forms, including, sterile fill & finish, oral solid dosage and biologics; clinical trial material development and manufacturing services; and, pharmaceutical product development. Its biologics segment, ReciBioPharm, works with customers to develop and commercialise advanced therapy medicinal products (ATMPs): pre‑clinical to clinical and commercial development and manufacture for new biological modalities, encompassing technologies based on live viruses and viral vectors, live‑microbial biopharmaceutical products, nucleic acid‑based mRNA and plasmid DNA production. Recipharm manufactures several hundred different products for customers ranging from big pharma to smaller research and development companies. It operates development and manufacturing facilities in France, Germany, India, Israel, Italy, Portugal, Spain, Sweden and the US and is headquartered in Stockholm, Sweden.
#J-18808-Ljbffr