We are looking for a
Quality Assurance & Regulatory Affairs Manager
Incumbent is responsible for the release of raw materials and finished products in a due term. In addition incumbent is responsible for maintaining the deviation/CAPA process as well as complaint handling system to ensure a systematic reporting of non-conformities and product problems and initiate appropriate investigations.
Responsible for the market release process (technical release) and responsible for the storage of technical release documentation as well as retention samples
Responsible for handling nonconfrorming products
Responsible for complaint handling process
Support handling of complaints and any other technical problems.
Responsible for QA follow-up of laboratory investigations (OOS) in collaboration with QC Manager
Participation in internal audit-program functioning as internal auditor.
Responsible for the product-related nonconformity handling process and the related CAPA subsystem
Responsible for the evaluation and approval of product-related changes
Follow-up of corrective actions which have been identified in non-conformity reports or audits and to improve processes within the QA department.
Supports the proper implementation and documentation of all product-related changes.
Incumbent is responsible to motivate his subordinates in a safe and healthy working environment in his department.
The incumbent shall have a good knowledge of the current applicable version of ISO 13485. He / She shall be familiar with the European Directive 98/79/EC, European Regulation IVR 2017/746 as well as CFR (Code of Federal Regulations) Title 21, part 820 and part 660 subpart D.
A bachelor's or master's degree in pharmacy, biology, pharmacology clinical medicine or related life science is required
Languages: German, english & french
Minimum of 7 years' experience in the biotech or pharmaceutical industry, with at least 3 years in Regulatory
Experience in leading and managing teams, setting clear direction, holding people accountable and fostering a collaborative team environment
Candidates must have thorough knowledge and understanding of pharmaceutical/biological product development and regulatory requirements for product development
Experience working within the regulatory affairs & quality assurance
Experience interfacing with regulatory agencies and proven skill at developing and implementing successful global regulatory strategies
Demonstrated experience in working with multiple stakeholders
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