Job Opportunities in Switzerland
July 31, 2024
Bachem Holding AG
Vionnaz
OTHER
Vice President Quality Assurance & Quality Control (f/m/d)
Bachem is a leading, innovation-driven company specializing in the development and manufacture of peptides and oligonucleotides. With over 50 years of experience and expertise Bachem provides products for research, clinical development and commercial application to pharmaceutical and biotechnology companies worldwide and offers a comprehensive range of services. Bachem operates internationally with headquarters in Switzerland and locations in Europe, the US and Asia. The company is listed on the SIX Swiss Exchange. For further information, see www.bachem.com.
To lead our Quality team, we are looking for a Vice President QA & QC (f/m/d) for our production site in Vionnaz (Valais/Wallis, Switzerland).
As the VP of QA & QC, you will play a pivotal role in ensuring the highest standards of quality and compliance across all aspects of our pharmaceutical operations. You will lead a team of experienced quality assurance professionals and leaders. You will collaborate closely with cross-functional teams to maintain and enhance our quality systems.
Your responsibilities:
Your profile:
Would you like to drive innovation together with us?
We look forward to receiving your complete application documents via our application portal.
Learn more about the Bachem Group and get inspired by our exciting work environment at our location in Vionnaz!
As the VP of QA & QC, you will play a pivotal role in ensuring the highest standards of quality and compliance across all aspects of our pharmaceutical operations. You will lead a team of experienced quality assurance professionals and leaders. You will collaborate closely with cross-functional teams to maintain and enhance our quality systems.
Your responsibilities:
- Overall responsibility for the development and implementation of the vision and strategy, as well as the budget for the quality function.
- Manage existing high-performing Quality organization and its capabilities, including providing mentorship and professional development coaching.
- Develop and oversee the implementation of comprehensive GXP quality assurance strategies to ensure compliance with regulatory requirements, industry standards, and company policies.
- Provide support to the GMP quality leaders, fostering a culture of excellence, accountability, and continuous improvement.
- Establish and manage an internal program for quality and regulatory inspections and audits.
- Oversee the design, implementation, and maintenance of robust quality management systems, including document control, deviation management, CAPA (Corrective and Preventive Action), and change control.
- Lead regulatory inspections, audits, and quality assessments, ensuring readiness and compliance with Swissmedic, FDA, and other regulatory agencies.
- Drive quality risk management initiatives, identifying and mitigating potential risks to product quality, safety, and regulatory compliance.
- Collaborate with cross-functional teams, including Research & Development, manufacturing, supply chain, and regulatory affairs, to ensure alignment and integration of quality assurance processes throughout the product lifecycle.
- Provide strategic guidance and support for product quality issues, deviations, investigations, and recalls, as needed.
- Stay abreast of evolving regulations, industry trends, and best practices in quality assurance and proactively implement necessary changes in collaboration with the global functions to maintain compliance and drive continuous improvement.
Your profile:
- Doctorate degree or Master’s degree in chemistry, pharmaceutical or biotech
- 7+ years’ Experience in Quality Assurance and GMP manufacturing environment
- Experience with GMP document control, validation, qualification and calibration
- Experience in the GMP regulated environment (EU-, US-, Swiss GMP regulations), preferably with processes involved in validation, manufacturing, release and distribution
- Strong skills in coordinating cross-departmental teams and negotiating. Able to interact effectively with people at all levels of the organization, supporting with a solution- and service oriented attitude.
- Strong organizational skills with a conscientious and structured way of working and with ability to successfully manage workload and timelines
- Very good communication skills (both written and oral)
-
Very good knowledge of French and English (oral and written expression)
Desirable
- Skilled in quality events management systems (e.g. QEM Master Control, Trackwise)
- Affinity to work with GMP-relevant IT Systems (e.g. LIMS, SAP) to achieve compliance in the management of GMP-relevant operations
- Skilled in risk management Know-how in data integrity and audit-trail review topics
- A dynamic and rapidly growing work environment with internal development opportunities
- Flexible working hours with home office days and an option for obtaining additional vacation days through workload reduction
- Employee development through numerous internal and external training opportunities
- 60% coverage of pension fund contributions by Bachem AG as well as option for extra-mandatory pension provision with our Pension Plan Plus
- Access to the Swibeco benefits platform with discounts from external partners
Would you like to drive innovation together with us?
We look forward to receiving your complete application documents via our application portal.
Learn more about the Bachem Group and get inspired by our exciting work environment at our location in Vionnaz!
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