QA Manager Biologics

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von: AXEPTA SA | localité: LausanneN: AXEPTASA

 

Our client based in the canton of Vaud is currently seeking a Biologics QA Manager to strengthen their team following an increase in activity. This assignment will be for a minimum duration of 6 months due to the company's growth.

This person will oversee the quality of clinical and commercial manufacturing and testing activities at CMOs for assigned products (drug substance and drug product). They facilitate the transfer of biologic compounds from development to commercialization, collaborating closely with internal and external stakeholders.

 

QA Manager Biologics

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%.

 

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