Description
On behalf of my client I am seeking for a QA Manager for their International Quality team based in Zürich region, Switzerland. The successful candidate will primarily focus on supporting the Senior Manager QA and will ensure that the external Contract Manufacturer are working in compliance with Regulatory Quality Policies and Procedures.Additional responsibilities include:
- Manage CMs to contractual obligations relative to the Quality Agreement, assuring products continuously meet pre-defined regulatory requirements.
- Primary Quality Assurance point of contact for a given contract site or product.
- Review and approve completed production batch records, Standard Operating Procedures, Work Instructions and Forms as applicable
Disposition drug substance, drug product or packaged goods
Review and approve Non Conformances and CAPA's and Initiate and own QA Non Conformances and CAPA's as needed. - Review and approve change control records, initiate and own QA
- Oversee and manage implementation of new or revised specifications and test methods at the Contract Sites ensuring all filing compliance requirements are met.
- Communication of site performance, which includes presenting Quality metrics to the Leadership Teams as needed.
- Participate in global Quality initiatives ensuring as needed
- Organize and manage Business Review
- Interaction with Client`s Global Compliance organization and Regulatory authorities during inspections at contract manufacturing sites.
PREFERRED QUALIFICATIONS:
- Minimum 5 years of experience in QA
- Master's degree in science or equivalent
- Fluency in English
- Strong interpersonal skills and team player as well as good negotiation and resolution skills.
- Good communication and presentation skills.
- Fluency in English, German and/or Italian preferred.
If you believe you are a suitable candidate for this position please dont hesitate to get in touch with me and send me your updated CV in word format on or give me a call on
Looking froward hearing from you.