Biologics QA Senior Manager (Project)

Roles and Responsibilities

• Work with the biologics management team to maintain a robust biologics quality systems.

• According to the requirements of contracted manufacturing process technology transfer, review relevant documents such as new product introduction evaluation, co-line production evaluation, process procedures, quality standards, batch production records, bill of materials, sampling plans, etc., to ensure the correctness, completeness, and consistency of document content.

• Oversight the production in CMO, including but not limited to, GMP pre-production readiness check, on-site inspections during production, as well as necessary quality verifications after production, to promptly identify and communicate issues and/or risks.

• Review the relevant records of batch production after execution, ensure the completeness, correctness, and consistency of the records, and complete the review records.

• Assess the materials related to the project and the certification status of material suppliers to ensure compliance with regulatory requirements.

• Participate in and review deviation investigations related to production to ensure thorough investigation.

• Review changes related to production, ensuring that change impact assessments are comprehensive and actions are reasonable and effective.

• As a project QA representative, conduct quality assessment and quality review to quality events, including but not limited to, deviations, change controls, product complaint, storage/shipping temperature excursions.

• Maintain, monitor and report key biologics quality performance indicators, as appropriate

• Coordinate quality internal audit

• Participate in CMO quality audit

• Maintain the quality agreement with CMO and ensure the operation compliance with assigned quality agreement

• Coordinate team to conduct regulatory and guidance gap assessment, ensuring compliance

• Maintain good communication with internal and external parties.

• Other related duties as assigned

Education and Qualification

• Bachelor's degree or above in pharmaceutical sciences, life sciences, biology, biotechnology chemistry, chemical engineering, or related majors

• A minimum experience of 8 years in pharmaceutical or biotechnology in quality assurance

• NMPA/FDA/EU GMP Know-how and understanding of ICH guidelines

• Experienced with tools usage like Veeva, Trackwise

• Experienced with quality assurance activities for biological investigational medicine products and commercial products production is required

• Experienced with supplier/CMO audits

• Participated in NMPA/FDA/EMA audits as QA representative

• Quality risk based, phase appropriate and continues improved mindset for quality systems management

• Strong follow-up， coordination and independent problem-solving abilities

• Fluent oral and written communication skills to effectively communicate, collaborate and positive interactions with peers and stakeholders