QA Manager (Pharma)

Mission Description:

This position will operationally lead and engage in technical and Quality investigations related to product Quality issues to determine root cause of the underlying issue and appropriate CAPA plan to mitigate and resolve the Quality issue.

This position will write and prepare Quality investigations in close collaboration with Technical experts and External Manufacturing organizations. The incumbent will have to present and explain the investigation at Senior Management Committees to allow Management to taking a managerial decision on a given issue.

Where such issues may lead to product recall from the market the position will take an active role in the recall execution team with preparation of recall related documents and recall execution follow-up with involved parties.

Mission responsibilities:

- Lead Quality investigation
- Request and access regulatory and technical information related with the products (internal and external)
- Prepare and write Quality and Technical Assessment documents
- Support for the preparation of technical meeting at Senior Management level Recall Committee meeting
- Prepare presentation and present issue at above meetings
- Prepare documentation for the recall execution
- Participate and lead recall execution team including document preparation, response to questions from authorities in the scope of recall execution, and reconciliation at related vendors
- Participate to meetings with stakeholders to update status of hot topics and maintain track tool update

Specific professional/technical expertise and key skills required:

- About 10 - 15 years' experience working in the pharmaceutical/biologics industry in a GMP Quality position with a profound knowledge and understanding of Quality management and operational GMP (manufacturing and/or quality control) experience
- Experience and knowledge about European Good Manufacturing Practices
- Good pharmaceutical technical understanding and expertise enabling to review and judge upon technical documents and technical problems related to manufacturing and analytical testing of pharmaceutical drug products
- A QA critical mind set on reviewing documents
- Fluent and confident use of English language verbally and in writing
- Must be knowledgeable in several areas of the global pharmaceutical industry, including the interpretation and practical application of applicable regulations. Has good background knowledge of the pharmaceutical industry from a business and technical perspective.
- Ability to completely work autonomously for the assigned project activities
- Must possess excellent interpersonal, verbal, and written communication skills at all levels internally and externally especially at senior management levels.
- Must be skilled and experienced in operating across cultures and in a multi-cultural environment
- Project management experience is nice to have