Manager, Quality Assurance Second Shift

MSD•Durham, NC

5d•$96,200 - $151,400•Onsite

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 will include end-to-end drug substance and drug product processing, 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 & Media, Drug Substance, and Drug Product throughout the project lifecycle. It ensures work proceeds in compliance with cGMP, regulations, and the company’s Quality Management System. The position also supports first-shift setup activities, operational and technical operations deviation management, site safety and quality programs, Aseptic Observer Program and Batch Record Review workstreams, and permanent inspection readiness. The manager makes decisions affecting team performance objectives and metrics, consulting the next-level manager on complex matters, and develops team members through coaching and developmental support.

Requirements

Bachelor’s degree in chemical engineering, biochemical engineering, biological systems engineering, biology, biochemistry, chemistry, or a related life science or engineering discipline, and five years of experience in the pharmaceutical industry or a highly regulated industry; OR a master’s degree in one of these fields and 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, with the ability to manage multiple priorities.
Demonstrated ability to work in fast-paced, complex environments and escalate appropriately.
Skills listed: analytical problem solving, analytical thinking, cGMP compliance, decision making, detail orientation, driving continuous improvement, key performance indicators, people leadership, quality auditing, quality control systems, quality documentation, quality management standards, quality management systems, root cause analysis, 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 a Shop Floor QA team 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 preventative actions, reviews, and approvals through quality systems such as CLUE and SAP.
Support and maintain 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 and Batch Record Review 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 proactively providing developmental support, coaching, and assistance to team members.
Support compliance with Durham Site policies and procedures that promote Permanent Inspection Readiness.