Associate Director of Quality Assurance

Job Title:
Associate Director of Quality Assurance

Job Overview:
The Associate Director of Quality Assurance will lead quality assurance activities in a fast-paced, GMP-regulated manufacturing environment. This role is responsible for driving a culture of quality, compliance, and operational excellence while ensuring inspection readiness and adherence to regulatory standards. The ideal candidate will combine strong leadership, technical expertise, and collaboration skills to guide QA operations across multiple shifts, support audits, and partner with cross-functional teams to deliver safe and high-quality products.

Job Responsibilities:

• Lead and manage a QA Operations team across three shifts to ensure resource alignment with production timelines and quality standards.

• Oversee compliance with cGMP, FDA, EMA, and other regulatory requirements while maintaining inspection readiness.

• Serve as a primary point of contact during audits, identifying and addressing quality gaps to support continuous improvement.

• Mentor, train, and develop QA staff on gowning, contamination controls, aseptic processes, and equipment verification.

• Prioritize and coordinate QA resources to balance production demands with product quality assurance.

• Collaborate with Operations to support on-the-floor batch record review, corrections, and process improvements.

• Develop and manage room and line clearance processes for formulation, aseptic filling, and packaging areas.

• Lead and oversee deviation investigations using root cause analysis and risk mitigation tools to resolve issues and prevent recurrence.

• Partner with EH&S and Operations to ensure safety compliance and enforcement of SOPs and quality standards.

• Utilize paper-based and electronic systems (Veeva, SCADA, BMS, CMMS, LIMS, etc.) to maintain data integrity and accurate documentation.

• Stay current with regulatory trends and industry best practices to strengthen quality and compliance strategies.

Qualifications:

• Bachelor’s degree in a scientific discipline such as Chemistry, Biology, Biochemistry, or Microbiology required.

• Minimum of 8 years of quality assurance experience in aseptic biopharmaceutical manufacturing.

• At least 5 years of proven leadership or supervisory experience.

• Hands-on experience with isolator-based aseptic processing.

• Expert knowledge of contamination controls, drug product manufacturing processes, and risk-based decision-making for product quality.

• Strong knowledge of FDA, EMA, and other regulatory authority requirements for quality and operations.

• Proficiency with computerized operational systems (SCADA) and reporting/analysis software (Word, Excel, Visio, JMP, Minitab).

• Advanced degree preferred.

• Certifications in risk management, quality process analysis, technical writing, and/or quality investigation a plus.

• Experience with Lean, Six Sigma, or continuous improvement principles preferred.