Sr. Manager, Quality Assurance

Job Responsibilities

• Ensure adherence to cGMP requirements (21 CFR 210/211, 820 as applicable), EU GMP, and ISO standards.
• Provide independent Quality oversight of manufacturing operations, including:
• In-process controls and testing
• Batch record review and approval
• Timely disposition decisions based on sound risk assessment and regulatory requirements
• Ensure production and process controls are aligned with validated states and lifecycle requirements
• Ensure all investigations, CAPA, deviations, change control, complaints, in your area of responsibility are effectively implemented, sustainable, and inspection-ready
• Maintain proactive and effective communication with R&D, Design, Regulatory Affairs, and Pharma stakeholders.

Compliance, Risk Management & Continuous Improvement

• Drive risk-based decision-making using quality risk management principles.
• Analyze trends across investigations, complaints, and process performance to identify systemic issues and drive improvements.
• Lead the development and documentation of structured, data-driven analyses to support root cause identification, decision-making, and continuous improvement initiatives.
• Serve as the QA Subject Matter Expert (SME) during internal and external regulatory inspections, ensuring accurate representation of quality systems and compliance posture.
• Ensure effectiveness of CAPAs through robust verification of effectiveness (VoE).
• Defines and anticipates data requirements, including non-standard datasets, and ensures the collection of robust, high-quality data to support the evaluation of complex issues and operational challenges.
• Leverages hypothesis-driven analysis and deep understanding of cause-and-effect relationships to evaluate complex processes, identify trends, and interpret data patterns.

Leadership & Talent Development

• Lead, coach, and develop a high-performing QA organization, ensuring appropriate capability across operations and quality systems.
• Establish clear accountability, drive ownership, urgency, and execution discipline across the team.
• Develop succession plans and ensure organizational readiness to sustain compliance.
• Foster a culture of quality, transparency, and continuous improvement.

Business & Strategic Contribution

• Act as a key contributor to the quality site leadership team, aligning quality strategy with business objectives.
• Manage departmental budget, resources, and priorities to ensure effective deployment aligned with business needs and compliance risks.