Quality Assurance Operations Manager

Responsibilities

• Serve as a Quality Operations leader providing quality oversight and support for GMP manufacturing operations, ensuring compliance with regulatory requirements, company procedures, and quality standards.
• Perform and approve batch disposition decisions for raw materials, intermediates, and drug products, ensuring timely and compliant product release.
• Lead comprehensive review and approval of batch production records, laboratory records, and associated GMP documentation to ensure accuracy, completeness, and adherence to cGMP requirements.
• Manage quality records including deviations, CAPAs, change controls, investigations, and other quality system records, ensuring timely closure and effective resolution.
• Provide quality oversight of aseptic manufacturing operations, ensuring adherence to contamination control strategies, aseptic techniques, and GMP behaviors.
• Partner closely with Manufacturing, Quality Control, Supply Chain, Validation, and Technical Operations to proactively identify and resolve quality and compliance issues.
• Participate in quality review boards and cross-functional governance meetings, providing risk-based recommendations and quality leadership.
• Author, review, revise, and approve SOPs, work instructions, specifications, and quality system documents.
• Support inspection readiness activities and participate in regulatory inspections, customer audits, and internal audits.
• Drive continuous improvement initiatives focused on compliance, efficiency, quality metrics, and operational excellence.
• Support onboarding, training, mentoring, and development of Quality Operations team members.

Qualifications & Skills

• Bachelor's degree in a scientific discipline (Biology, Chemistry, Biochemistry, Biotechnology, or related field) required.
• Minimum of 5–7 years of Quality Assurance experience in a regulated pharmaceutical, biotechnology, or cell and gene therapy environment.
• One to three years of supervisory or management experience preferred.
• Demonstrated leadership abilities with experience coaching, mentoring, and developing team members.
• Basic understanding of Cell and Gene Therapy manufacturing processes and quality systems preferred.
• Experience supporting Quality Assurance activities within manufacturing, quality control, and/or quality systems operations.
• Familiarity with applicable regulatory requirements, industry guidance documents, and quality standards.
• Effective interpersonal skills with the ability to collaborate across cross-functional teams.
• Excellent organizational skills and attention to detail.
• Able to prioritize multiple tasks and manage competing deadlines in a fast-paced environment.
• Strong verbal and written communication skills.
• Strong analytical and problem-solving skills.
• Proficiency with Microsoft Office Suite and quality management systems (e.g., electronic document management systems, deviation and change control systems).