Manager, Quality Assurance Second Shift

MSD • Durham, NC

4d

About The Position

The Quality Assurance Manager will direct Shop Floor Quality Assurance (SFQA) B160 at a new manufacturing facility built to expand production capacity. The facility will support end-to-end processing of drug substance and drug product, including biotech culture growth, harvest, lyophilization, product inspection, and quality control laboratories. The role supports process and technology introduction, compliance improvements, and manufacturing readiness for commercial production, with a focus on Shop Floor QA oversight during the second (evening) shift.

Reporting to the Quality Assurance Organization, the manager independently leads the second-shift Shop Floor QA team, providing end-to-end support for Production Support & Media, Drug Substance, and Drug Product throughout the project lifecycle. The role ensures compliance with cGMP, applicable regulations, and the Company’s Quality Management System, and supports first-shift setup activities. It also supports operational and technical operations deviation management, site safety and quality routines, aseptic observation and batch record review workstreams, team development, and permanent inspection readiness.

Requirements

• Bachelor’s degree in chemical engineering, biochemical engineering, biological systems engineering, biology, biochemistry, chemistry, or a related life science or engineering discipline, plus five years of experience in the pharmaceutical industry or a highly regulated industry; alternatively, a master’s degree in one of these fields plus three years of such experience.
• At least two years of experience in aseptic manufacturing or another cleanroom environment.
• At least one year of people management or equivalent direct leadership experience.
• Strong contemporary knowledge of relevant current good manufacturing practices (cGMPs), regulations, and current industry trends.
• Effective decision-making, problem-solving, and communication skills.
• Ability to manage multiple priorities.
• Demonstrated ability to work in fast-paced, complex environments and escalate appropriately.

Nice To Haves

• GMP quality experience with media, biological drug substance, and drug product.
• Strong background in cGMP document review and approval.
• Strong background in cGMP compliance standards, including QMS, EHS, and site SOPs.
• Independent, self-directed planning, scheduling, and time-management skills.
• Experience with Quality Risk Management.
• Experience with Deviation Management.
• Experience with Kneat, Veeva Vault, MEDS, SAP, Electronic Batch Records (MES), Trackwise, and GLIMS.
• Root Cause Analysis and problem-solving experience using MPS/LSS tools, including demonstrated proficiency in MPS 8-Step Problem Solving.
• Proficiency with Microsoft Excel, Word, PowerPoint, and Teams.

Responsibilities

• Independently manage the second-shift Shop Floor Quality Assurance team.
• Lead the Shop Floor QA team in providing end-to-end QA support for Production Support & Media, Drug Substance, and Drug Product throughout the project lifecycle.
• Ensure Shop Floor QA activities comply with cGMP, regulations, and the Company’s Quality Management System, including batch record review, process and aseptic observations, critical site review, critical alarm management, and environmental monitoring incursion or excursion response.
• Support and prepare setup activities for first-shift Shop Floor QA.
• Support Operations and Technical Operations Deviation Management groups with event assignments, classifications, investigations, corrective and preventive actions, reviews, and approvals using quality systems such as CLUE and SAP.
• Promote a “Safety First,” “Quality Always” environment and participate in site GEMBAs for safety and quality compliance.
• Escalate and collaborate on quality and compliance issues through established site Tiers.
• Lead and support the Aseptic Observer Program and Batch Record Review workstreams for the SFQA area.
• Make decisions guided by policies and procedures that affect the team’s performance objectives and metrics, and consult the next-level manager as needed on complex decisions.
• Sponsor and develop a high-performing organization culture by providing team members with developmental support, coaching, and assistance.
• Support compliance with Durham Site policies and procedures that promote Permanent Inspection Readiness.

Benefits

• Medical, dental, vision healthcare, and other insurance benefits for employees and families.
• Retirement benefits, including 401(k).
• Paid holidays, vacation, and compassionate and sick days.
• Eligibility for an annual bonus and long-term incentive, if applicable.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager