Associate Director Quality Assurance

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Job Description

The Associate Director, Quality Assurance provides strategic leadership and oversight of the site Manufacturing Operations to ensure compliance with the applicable regulations such as: FDA regulations (21 CFR Parts 210, 211, and 820 as applicable), EU GMP, and ISO 13485 standards.

This role is accountable for Quality oversight across the manufacturing process of formulation, filling, triton and Cascade Water Sterilization process (CWS). The position supports and oversight contamination control strategies, risk-based decision-making, and sustainable compliance culture, while enabling operational excellence and supply continuity.

The Associate Director acts as a key member of the site quality leadership team, driving quality strategy, regulatory readiness, and continuous improvement initiatives aligned with global and site objectives.

Works collaboratively with Manufacturing, Supply Chain, EHS, Engineering, and other cross-functional teams.

Job Responsibilities:

Operations Quality Oversight

• 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
  • Ensure timely disposition decisions based on sound risk assessment and regulatory requirements.
  • Drive increased Quality presence on the shop floor to ensure real-time compliance and issue resolution.
  • 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.
• Leads the development and documentation of structured, data-driven analyses to support root cause identification, decision-making, and continuous improvement initiatives.
• Serves 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.
• Serves as a Subject Matter Expert (SME) in leading and documenting comprehensive, data-driven situational analyses to support strategic decision-making, regulatory compliance, and continuous improvement initiatives.

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…