Quality Assurance Manager

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 Biosynth’s global standards. The Quality Assurance Manager is a part of the global quality team and plays a pivotal role in Biosynth’s constant strive for quality improvement.

• 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

• 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 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

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.

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.

Biosynth’s 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.

Application Question(s):

• Do you have previous experience of working as a Quality Assurance Officer in the Life Sciences/Pharmaceutical industry?

Education:

• Master's (Required)

Experience:

• Quality Assurance Manager: 2 years (Required)
• ISO9001 and GMP: 2 years (Required)

Work Location: In person