Quality Assurance Manager

7 dagen geleden

Lelystad, Nederland Biosynth Voltijd

We take great pride in our vast range of chemical and biochemical products, and our high standards are maintained through great people, who share our values, and want to do the very best job possible, every day.

We acknowledge the important part our team members, who are based over three continents, play in our continued success.

**Main Purpose of the Job**

***

This role involves overseeing the entire local quality assurance program, ensuring product safety and efficacy, and maintaining compliance with industry and Biosynths global standards. The Quality Assurance Manager is a part of the global quality team and plays a pivotal role in Biosynths constant strive for quality improvement.

Focus is on GMP.

**Role and Responsibilities**
- Lead and manage quality assurance processes ensuring efficient and effective operation.
- Steer the quality performance throughout the company to maintain a fully valid GMP environment.
- Develop, implement, and oversee quality assurance policies and procedures.
- Plan, manage and conduct internal and external audits.
- Ensure compliance with industry standards, regulatory requirements, and company quality objectives.
- Drive investigations into customer complaints, non-conforming products, and deviations.
- Coordinate with production and QC teams for compliance and quality improvement initiatives.
- Facilitate international collaboration with other global QA teams for global quality assurance consistency.
- Develop and implement training programs for quality assurance and compliance for staff.
- Ensure ongoing adherence to local, national, and international standards and legislation.
- Oversee and enhance quality assurance protocols, focusing on both the production process and customer engagement processes, ensuring high standards are maintained and continually improved.
- Active contribution in the global harmonization processes and documentation of all Biosynth GMP sites
- Implementation of ISO 13485 standard
- Contribution to validation activities of electronic QMS

**Requirements**:
- PhD in Organic Chemistry
- Previous experience in a Quality Assurance managerial role, specifically in the life sciences or pharmaceutical Industry is essential
- Demonstrated success in managing audits and maintaining compliance with regulatory authorities such as the EPA, USDA, FDA, and other relevant organizations.
- In-depth knowledge of quality standards and regulations ISO 9001 and GMP
- Excellent communication and interpersonal skills in combination with assertiveness
- Excellent organizational skills
- Attention to detail
- Pragmatic working attitude
- Efficient and eloquent writing skills
- Ability to work under pressure and meet deadlines, while maintaining a positive attitude.
- Experience managing a quality team would be preferred
- Knowledge of ISO 13485 would be desirable

**About us**

Biosynth® is an innovative life sciences reagents, custom synthesis and manufacturing services company headquartered in Staad, Switzerland. We are by scientists, for scientists, securing supply chains with consistent quality, across the globe. As a trusted supplier, manufacturer and partner to the pharmaceutical, life science and diagnostic industries, as well as food, agrochemical and cosmetic customers, we have facilities on three continents and a rapid global distribution network. Our main production laboratories are located in Switzerland, the UK, Slovakia and China, with peptide and antibody production in the US, the Netherlands. Bioconjugation projects are carried out in Germany, Enzyme projects are based in Austria and biological IVD reagents in Ireland.

Together with 4 sites; one in the US, 2 in the UK and the Lelystad site (formerly Pepscan) these form the peptide division, with a complete range of peptide products and services.

Biosynths custom peptide production uses state-of-the-art instruments at facilities in Lelystad (NL), Gardner (MA, USA) and Louisville (KE, USA). Complex peptides can be produced according to GMP for clinical trials and are always produced at ISO9001 standards.

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