Quality Assurance Manager

Job Title:

Quality Assurance Manager Job Description This role leads and supports quality assurance and quality control activities for biologics manufacturing, with a strong focus on testing, method development, and robust quality systems. The Quality Assurance Manager reviews and supports batch records, investigations, CAPAs, change controls, and batch disposition activities for both internal manufacturing and external contract manufacturing partners. This position plays a key role in ensuring GMP compliance, maintaining a strong quality management system, and contributing to the development and implementation of QC methods that will support multiple clinical-stage molecules.

• Support quality control activities, including product testing, stability control, and analytical method development for biologics.
• Perform detailed batch record reviews for internal manufacturing operations to ensure compliance with GMP and internal quality standards.
• Review batch records and quality documentation from external contract manufacturing organizations (CMOs) and provide oversight to ensure adherence to quality and regulatory requirements.
• Help perform and document investigations related to deviations, nonconformances, and quality events, ensuring thorough root cause analysis and effective corrective and preventive actions (CAPAs).
• Assist with batch disposition activities by reviewing data, documentation, and quality records to support timely and compliant release decisions.
• Support and help maintain the quality management system (QMS), including quality procedures, records, and data review processes.
• Contribute to the development, review, and implementation of QC methods, ensuring they are robust, compliant, and suitable for ongoing use by the quality team.
• Assist with change control activities, including initiation, impact assessment, documentation, and implementation of changes to processes, methods, or systems.
• Collaborate closely with QC departments and internal analytical development/quality control (AD/QC) teams to ensure alignment on testing strategies, data review, and quality expectations.
• Provide quality oversight for CMOs by reviewing quality data, documentation, and performance, and by supporting effective communication and issue resolution.
• Support biologics and drug manufacturing operations by ensuring that quality requirements are clearly defined, communicated, and followed.
• Contribute to the continuous improvement of quality processes, documentation practices, and data review activities.
• Act as an individual contributor with managerial-level responsibility for quality activities, without direct people management, while influencing cross-functional teams through strong communication and collaboration.

• 1015 years of experience working in a quality capacity within the life sciences or biopharmaceutical industry.
• Bachelors degree (BS) in a life science discipline.
• Extensive experience in quality assurance (QA) and quality control (QC) roles, supporting biologics or drug manufacturing companies.
• Strong experience in GMP (Good Manufacturing Practice) environments and quality management systems (QMS).
• Hands-on experience with batch record review for internal manufacturing operations.
• Proven experience in managing and overseeing CMOs, including review of their batch records and quality documentation.
• Demonstrated experience with investigations, root cause analysis, and corrective and preventive actions (CAPA).
• Experience with change control processes in a regulated environment.
• Familiarity with QC method development and method review for biologics.
• Strong skills in data review and documentation practices within a regulated quality environment.
• Excellent communication skills with the ability to work effectively with a variety of stakeholders.
• Demonstrated ability to work hard, collaborate well, and maintain positive working relationships across teams.

• Experience supporting multiple biologic molecules at clinical stages, including stage II development.
• Experience in stability control and related quality activities for biologic products.
• Experience working closely with internal QC and analytical development teams.
• Ability to contribute to the design and implementation of QC methods that will be used long term by the quality organization.
• Strong organizational skills and attention to detail when reviewing data, documentation, and quality records.
• Ability to operate as an individual…