Sr Manager, QA Operations

Emergent BioSolutions • Canton, MI

22h

About The Position

The Senior Manager, Quality Assurance Operations provides senior leadership and oversight of GMP Quality Assurance Operations at a vaccine Drug Substance manufacturing site, ensuring compliant execution of manufacturing activities and effective implementation of site quality systems in alignment with Site Quality Management expectations and global Quality standards. This role is accountable for real time QA oversight of manufacturing operations, lifecycle management of deviations, CAPAs, change controls, validation activities, and risk management, while operating as a key Quality decision-maker independent of Production, consistent with CGMP requirements. The position partners closely with QA Compliance and Supplier Quality, Quality Control, and Site Quality Management to ensure effective inspection readiness, audit support, risk escalation, and Quality Management Review (QMR) execution. The Sr. Manager supports internal and external projects, including technical transfers, supplier and partner interactions, and network initiatives, and is expected to cross train within the Quality Unit to ensure continuity of critical quality responsibilities. This role directly contributes to sustaining a state of control, regulatory confidence, and a strong quality culture across site operations.

Requirements

• Bachelor’s degree in Biological Sciences, Chemistry, Engineering, or a related scientific discipline required.
• 8–10+ years of progressive GMP Quality experience within pharmaceutical or biotechnology manufacturing.
• Demonstrated experience supporting biologics or vaccine Drug Substance operations.
• Proven leadership of QA Operations and Quality Systems in a regulated manufacturing environment.
• Prior experience supporting regulatory inspections, internal audits, and inspection readiness activities.
• Experience supporting technical transfers, validation activities, and cross functional quality initiatives.
• Previous people leadership experience is required.
• Strong working knowledge of CGMP regulations, industry guidance (FDA, EMA, ICH), and phase-appropriate quality expectations.
• Demonstrated ability to assess risk, interpret complex data, and make sound quality decisions in a fast-paced manufacturing environment.
• Excellent written and verbal communication skills, including the ability to present complex quality topics to senior leadership.
• Influential leader capable of operating effectively in a cross-functional, matrixed organization.
• Ability to critically review and approve SOPs, validation documents, investigations, protocols, and regulatory responses.
• Strong organizational skills with the ability to manage multiple priorities simultaneously.
• Proficiency with MS Office applications (Word, Excel, PowerPoint) and electronic quality management systems (eQMS).

Nice To Haves

• Advanced degree preferred.

Responsibilities

• Provide senior QA oversight for GMP manufacturing operations, ensuring controls are implemented and executed in accordance with approved procedures and regulatory requirements.
• Maintain robust QA presence on the floor, supporting real time decision making, logbook review, batch documentation review, and issue resolution.
• Ensure Quality remains independent of production while enabling compliant execution.
• Lead and oversee Deviations, CAPAs, Change Controls, Effectiveness Checks, and other site quality systems in accordance with SOP040945 and global procedures.
• Ensure timely, high quality investigations using sound root cause analysis and risk-based decision making.
• Review and approve complex investigations, including manufacturing deviations, OOS/OOT events, and excursions.
• Apply Quality Risk Management (ICH Q9) principles to assess, escalate, and mitigate quality and compliance risks.
• Support site and corporate Quality Risk assessments and ensure alignment with Site Quality Management expectations.
• Identify adverse trends and partner with QA Compliance to ensure appropriate escalation to senior management.
• Provide QA oversight and approval for qualification and validation protocols, reports, and deviations for facilities, utilities, equipment, processes, QC methods, and computerized systems.
• Ensure validation activities align with regulatory expectations and site control strategy.
• Support internal audits and regulatory inspections by ensuring QA Operations processes, records, and personnel are inspection ready.
• Participate as a Subject Matter Expert during regulatory inspections and audits, supporting responses and remediation activities in partnership with QA Compliance.
• Ensure operational readiness for FDA (CBER), global health authorities, and partner audits.
• Develop, trend, and present Key Performance Indicators (KPIs) supporting Quality Management Review (QMR).
• Provide operational quality insights to support assessment of process performance, product quality trends, and state of control.
• Communicate quality performance to site and corporate Quality leadership.
• Lead, coach, and develop QA Operations personnel, ensuring proper training, qualification, and performance management.
• Promote cross-training within the Quality Unit to support continuity of quality responsibilities.
• Foster a culture of accountability, engagement, and continuous improvement.
• Provide QA Operations leadership for technology transfer activities, lifecycle changes, and introduction of new or modified processes.
• Support internal and external partnerships by ensuring Quality requirements are integrated into execution and risk is appropriately managed.
• Collaborate with Supplier Quality and Compliance functions to ensure operational impacts from supplier or partner activities are properly assessed.

Benefits

• Eligibility for additional incentive compensation, including merit increases, annual bonus, and/or long-term incentives in the form of stock options.
• Comprehensive benefits package.

What This Job Offers

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