Yours Responsibilities

- Serve as the QA expert for assigned biological products.

- Oversee the quality of assigned Clinical and Commercial CMOs, including compliance and performance monitoring.

- Manage quality throughout the lifecycle of assigned projects, from development and process/method validation/transfer to registration and commercialization.

- Make batch disposition decisions after thoroughly reviewing batch documentation.

- Collaborate with the other departments for batch confirmation and certification in relevant markets.

- Maintain and control Product Batch records and databases.

- Manage and approve deviations, OOS, investigations, CAPAs, and Change Controls promptly.

- Conduct quality reviews of stability data for products under their scope.

- Establish and maintain Quality and Technical Agreements with assigned Clinical and Commercial CMOs.

- Support the maintenance of the Quality Management System, focusing on biologics-related SOPs.

- Perform internal and external audits as a qualified auditor, review and approve responses, and ensure CAPA follow-up with concerned CMOs.

- Provide QA support to the RA-CMC group for regulatory submissions and follow-ups.

- Implement Quality Risk Management to identify and mitigate risks related to product quality, safety, and GMP compliance of the assigned CMO.

- Interpret and implement GMP, general regulatory requirements, and Quality systems regulations in manufacturing.

Your Qualifications:

- Master's degree in natural or applied sciences (Pharmacy, Chemistry, Biotechnology, Engineering).

- Minimum 5 years of experience in Quality Operations for pharmaceuticals.

- Expertise in manufacturing and testing biotechnology products.

- Experience overseeing Contractor Quality.

- In-depth knowledge of cGMP and regulatory requirements

- Proven ability to write technical documents, such as APQR.

- Track record in project management as a project team member, able to contribute to multiple ongoing projects.

- Knowledge of technical transfer requirements for Biologics.

- Strong interpersonal skills.

- Excellent verbal and written communication skills, with a well-structured communication and presentation ability.

- Commitment to continuous improvement.

- Results-oriented, with skills in negotiation, empathy, diplomacy, and common sense.

- Fluent in written and spoken English (company language).

- Willing to travel up to 20%.