Manager, Quality Assurance Second Shift
About The Position
The Quality Assurance Manager will independently manage the Shop Floor Quality Assurance (SFQA) team on second shift, supporting process and technology introduction, compliance improvements, and manufacturing readiness for commercial production at a new manufacturing facility. The facility is intended to expand manufacturing capacity and includes end-to-end processing of drug substance and drug product, including biotech culture growth, harvest, lyophilization, product inspection, and quality control laboratories. The role provides end-to-end Shop Floor QA oversight for Production Support and Media, Drug Substance, and Drug Product throughout the project lifecycle. The position supports Second Shift (Evening Shift) and also helps prepare set-up activities for SFQA First Shift (Days). The manager works with Operations and Technical Operations Deviation Management groups and supports compliance with cGMP, applicable regulations, the company Quality Management System, and Durham Site policies and procedures.
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; OR a master’s degree in one of these disciplines, plus three years of such experience.
- At least two years of experience in aseptic manufacturing or another clean room environment.
- At least one year in 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, with the ability to manage multiple priorities.
- Demonstrated ability to work in fast-paced, complex environments and escalate appropriately.
- Skills listed as required: analytical problem solving, analytical thinking, cGMP compliance, decision making, detail orientation, driving continuous improvement, key performance indicators (KPI), people leadership, quality auditing, quality control systems, quality documentation, quality management standards, quality management systems (QMS), root cause analysis (RCA), and supplier quality management.
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 skills in planning, scheduling, and time management.
- 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 Shop Floor Quality Assurance team on second shift.
- Lead Shop Floor QA support for Production Support and Media, Drug Substance, and Drug Product throughout the project lifecycle.
- Ensure Shop Floor QA activities comply with cGMP, regulations, and the company 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 set-up activities for SFQA First Shift (Days).
- Support Operations and Technical Operations Deviation Management groups with event assignments, classifications, investigations, corrective and preventative actions, reviews, and approvals through current Quality Systems, such as CLUE and SAP.
- Promote a “Safety First,” “Quality Always” environment, including participation 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 (AOP) and Batch Record Review (BRR) workstreams for the SFQA area.
- Make decisions guided by policies and procedures that affect the team’s ability to meet performance objectives and metrics, consulting the next-level manager as needed on complex decisions.
- Sponsor and develop a high-performing organization culture by providing developmental support, coaching, and assistance to team members.
- Support compliance with Durham Site policies and procedures that promote Permanent Inspection Readiness (PIR).
Benefits
- Medical, dental, and vision healthcare and other insurance benefits for employees and family.
- Retirement benefits, including 401(k).
- Paid holidays, vacation, and compassionate and sick days.
- Eligible for annual bonus and long-term incentive, if applicable.
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What This Job Offers
Job Type
Full-time
Career Level
Manager
