Manager, Quality Assurance at ZYLIDAC BIO LLC – Emeryville, California

Zylidac Bio LLC is seeking a highly motivated Quality Assurance Manager. The QA Manager will lead and oversee all aspects of Quality Assurance Function within a Biologics CDMO. The role ensures that manufacturing, testing and development activities for biologics products comply with cGMP, regulatory requirements and internal quality standards. The QA Manager will serve as a Key Partner to Operations, QC, Regulatory Teams, ensuring high quality deliverables for clients. The position will report directly to the Director of QA. This exciting opening offers the candidate the opportunity to be a part of a professional, customer-focused, pharmaceutical company with a competitive salary and full benefits package.

Responsibilities

• Develop, implement and maintain QA policies, procedures and systems in compliance with cGMP, ICH, FDA and EMA regulations
• Review and approve batch records, deviation reports, CAPAs, change controls, validation protocols and reports and other quality documentation
• Perform batch releases for raw materials, drug substances and drug product and intermediates
• Provide QA support for manufacturing operations on the floor
• Conduct internal audits and support external audits and inspections (Clients, regulatory agencies) and inspection readiness.
• Collaborate with manufacturing, QC to ensure process and product quality from development through commercial supply.
• Support tech transfers and new product introductions by ensuring QA oversight of documentation, qualification and validation activities
• Monitor and report on Key quality metrics, driving continuous improvement initiatives across organization.
• Stay current with regulatory changes, industry best practices, and emerging trends in biologics manufacturing and quality

QUALIFICATIONS – SKILLS & REQUIREMENTS:

• Strong knowledge of cGMPs, ICH guidelines, FDA, EMA and other regulatory standards
• Experiences with cell culture fermentation, Purification and aseptic processing preferred.
• Strong communication and interpersonal skills with ability to influence cross-functional teams
• Proficiency in electronic QMS and Document Control systems

Key Competencies:

• Strategic thinking and decision-making in a highly regulated environment.
• Attention to detail and problem-solving skills
• Ability to manage multiple priorities in a fast-paced environment
• Commitment to foster a culture of Compliance, Continuous improvement and Quality Excellence

EDUCATION & EXPERIENCE:

• Bachelor’s or Master’s degree in life sciences or related field
• Minimum 7-10 years of experience in QA in a biologics manufacturing site