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 at our Lelystad site (the Netherlands), 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 drug substance (peptides)..

Role and Responsibilities

• Lead and manage quality assurance processes ensuring efficient and effective operation.
• Approving or rejecting, as they see fit, starting materials, packaging materials, and intermediate, bulk and finished products.
• Evaluating batch records
• Approving specifications, sampling instructions, test methods and other quality control procedures; and ensuring that all necessary testing is carried out;
• Ensuring the qualification and maintenance of facility and equipment;
• Ensuring that the appropriate validations are done, according to industry standards and regulatory requirements.
• 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 including adherence to local, national, and international legislation.
• 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 site QA teams for global quality assurance consistency; including an active contribution in the global harmonization processes and documentation of all Biosynth GMP sites Develop and implement training programs for quality assurance and compliance for staff.
• Contribution to validation activities of electronic QMS

Requirements

• MSc. or Ph.D. 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 IGJ, EPA, USDA, FDA, and other relevant organizations.
• In-depth knowledge of with quality standards and regulations ISO 9001 and GMP
• Good level of computer proficiency (MS Office applications).
• 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, 2 in the US and 2 in the UK, the Lelystad site (formerly Pepscan) forms the peptide division, with a complete range of peptide products and services.

The Biosynth peptide division (www.biosynth.com/peptides) offers an array of capabilities, from phage display lead discovery to lead-optimization and production facilities for R&D- to GMP-grade peptides, including libraries and neoantigen vaccines. These services are built on proprietary technologies and platforms. Among its patents is the CLIPS™ technology, which locks peptides into their active conformations. It has built unrivalled expertise in complex, constrained, multimeric, and other special peptides.