Job Details
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 with manufacturing laboratories in Switzerland, the United Kingdom, Slovakia and China, and distribution centres in the United States, play, in our continued success.
Main Purpose of the Job
Biosynth is seeking an experienced Quality Assurance Manager for our peptide production and distribution hub. This position will be based out of Louisville, Kentucky. This role involves overseeing the entire quality assurance program, ensuring product safety and efficacy, and maintaining compliance with industry standards. The Quality Assurance Manager will be a part of our global quality team and will also oversee our Quality Business in Louisville, Kentucky, and Gardner, Massachusetts, playing a pivotal role in strategic planning for quality improvement.
Key Responsibilities
- Lead and manage quality assurance processes ensuring efficient and effective operation.
- Develop, implement, and oversee quality assurance policies and procedures across multiple US facilities.
- Conduct and supervise regular audits and inspections of production processes and products.
- Ensure compliance with industry standards, regulatory requirements, and company quality objectives.
- Drive investigations into customer complaints, non-conforming products, and production issues.
- Coordinate with production and QC teams for compliance and quality improvement initiatives.
- Analyze data to develop strategies for continuous improvement in the quality system.
- Manage regulatory compliance issues, including preparation and execution of audit plans.
- Oversee external audits of suppliers and contractors, ensuring adherence to quality standards.
- 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.
Candidate Requirements
- A degree in Biology, Chemistry, Biochemistry, or a related field. Advanced degree is preferred.
- Extensive experience in a quality assurance managerial role, specifically in the life sciences or pharmaceutical industry.
- Proven leadership skills with experience managing and developing a team.
- In-depth familiarity with quality standards and regulations (e.g., ISO, cGMP).
- Demonstrated success in managing audits and maintaining compliance with regulatory authorities such as the EPA, USDA, FDA, and other relevant organizations.
- Exceptional analytical, strategic planning, and problem-solving skills.
- Outstanding communication and interpersonal skills.
- Proficiency in Microsoft Office, quality management software. Experience with M-Files, LIMS systems and SAP is highly beneficial.
- Ability to work independently and collaboratively, managing multiple priorities in a dynamic environment.
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 UK and the Netherlands. Enzyme projects are based in Austria, bioconjugation projects in Germany and biological IVD reagents in Ireland.
Biosynth, is proud to be an equal opportunity employer. We value diversity and are committed to creating a workplace that reflects this commitment. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age or veteran status.
Recruitment agencies - we are unable to accept unsolicited CVs and communications from external recruiters. We do not engage with recruitment agencies to recruit for our roles.