Team Lead Quality Drug Product Operations

Team Lead Quality Drug Product Operations

Location: Framingham, MA

About the job

We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families.

Our Team:

The purpose of this position is to oversee quality assurance for the clinical injectables manufacturing (CIM) team in Framingham as well as drug substance (DS) and drug product (DP) release for the genomic medicines unit (GMU) and DP release for CIM.

We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve peoples lives. Were also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?

Main responsibilities:

• Take the lead overseeing the Framingham Clinical Injectables Manufacturing (CIM) team, developing and coaching talents for optimal engagement and performance

• Responsible for the batch release process of biologics drug product and the genomic medicines unit (GMU)

• Maintain positive relationships with stakeholders by responding promptly to inquiries, requests and complaints

• Engineering and validation tasks related to facility, utilities, and equipment

• Responsible for QA oversight of deviations, CAPA, self-inspection, Quality Alerts, product complaints, and change controls

• Knowledgeable of proper Aseptic operations and Annex 1 adherence

• Oversee the visual inspection and acceptable quality limit (AQL) of the final drug product

• Support and participate pre-approval inspection (PAI) activities

• In-depth knowledge of quality regulations and guidelines applicable to R&D pharmaceutical activities

• Excellent interpersonal, communication, and facilitation skills since this position requires frequent direct interaction with and appreciation for the relationship side of our R&D partners, CMOs, CLOs.

• Must be familiar with all processes associated with batch releases (review of batch records, COAs, COCs, CAPAs, deviations, change controls, etc.), quality agreements, and audits

• Knowledgeable on current regulatory guidance or requirements (i.e., ICH Q9, Annex 3, Annex 13, Annex 16, Eudralex Vol 4 GMPs specific to ATMPs)

• Thorough understanding of contamination control and sterility assurance regulatory requirements and industry best practices

• Able to identify, escalate, and manage quality alerts and other critical investigations. To rapidly and properly assess safety, identity, strength, purity, quality (SISPQ)

About you

• Master's degree in science or engineering with 8 years of relevant experience, OR bachelor's degree in science or engineering with 10 years of relevant experience

• Demonstrated expertise in pharmaceutical cGMP, ICH, FDA, and EMA regulations

• Strong background in Drug Product manufacturing regulations and guidance

• Proven experience in Chemistry Manufacturing Controls (CMC) and regulatory dossier preparation

• Thorough understanding of R&D processes, specifically in CMC-related fields

• Fluent English proficiency (written and verbal)

• Advanced technical writing and communication capabilities

• Demonstrated project management experience in complex, multicultural environments

• Track record of cross-functional collaboration with Development, Manufacturing, Engineering, Digital, Quality, Procurement, and Regulatory Affairs teams

% Remote working and % of travel expected: Up to 40% Remote working and Responsible for travel to various contract facility sites as needed for CMO relationship/production management and/or Person in Plant, 20% travel, Domestic and International.

Why Choose Us?

• Bring the miracles of science to life alongside a supportive, future-focused team.

• Discover endless opportunities to grow your talent and drive your career, whether its through a promotion or lateral move, at home or internationally.

• Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.

• Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks gender-neutral parental leave.