QA Visp Site Lead everyone
Visp - Switzerland
Job Summary
About Us
ten23 health is a human-centric and sustainable strategic partner of choice for the pharmaceutical industry and biotech start-ups for the development manufacture and testing of tomorrows medicines. We support our clients in developing differentiated stable usable and safe injectable treatments for patients.
Your mission
We are seeking a dynamic and highly experienced Head of Quality & GMP Operations to lead and evolve our Quality Management Systems (QMS) and ensure unwavering compliance within our manufacturing environment. This pivotal role requires a seasoned quality leader who can not only manage complex quality processes but also drive cultural transformation build high-performing teams and strategically align quality with business objectives.
Your responsibilities will include
Your responsibilities will include
- Lead the development optimization and remediation of robust Quality Management Systems (QMS) in alignment with global GMP regulations (FDA EMA ICH).
- Expertly manage core quality processes including deviations CAPAs change control document management and comprehensive audit readiness.
- Apply deep understanding of aseptic processing principles environmental monitoring cleanroom behaviours and sophisticated contamination control strategies to ensure product integrity.
- Champion and lead significant cultural and operational transformation initiatives within the quality function and across the organization.
- Build reshape and continuously foster a strong quality culture within a dynamic and fast-paced environment.
- Drive accountability for quality and compliance across all cross-functional teams extending beyond the Quality Assurance department.
- Create and champion an environment where compliance goals are seamlessly integrated with and actively support broader business objectives.
- Mentor coach and develop Quality Assurance professionals fostering a high-performing and engaged team.
- Work collaboratively and effectively with manufacturing technical operations and supply chain teams understanding and supporting their operational priorities while consistently upholding stringent quality standards.
- Capable of engaging influencing and communicating effectively at all organizational levels from floor staff to executive leadership.
- Transparent persuasive and adept at leading through influence skilfully managing resistance and building crucial buy-in for new systems tools and ways of working.
- Drive efficiency by simplifying and streamlining QA processes without compromising compliance or effectiveness.
- Make informed data-driven decisions understand when escalation is necessary and apply sound risk management principles to QA decision-making and process optimization.
Your profile
We are looking for someone with:
- Proven experience in a GMP-regulated environment is essential.
- Demonstrated leadership in building optimizing or remediating Quality Management Systems (QMS) in line with global GMP regulations (FDA EMA ICH).
- Strong track record managing end-to-end quality processes including deviations CAPAs change control document management and audit readiness.
- Deep understanding of aseptic processing principles environmental monitoring cleanroom behaviours and contamination control strategies.
- Exceptional leadership skills with a proven ability to drive cultural and operational transformation.
- Demonstrated ability to build and foster a strong quality culture.
- Highly collaborative with strong experience working closely with manufacturing tech ops and supply chain teams.
- Excellent communication negotiation and influence skills capable of engaging diverse stakeholders.
- A strategic thinker with a pragmatic approach to problem-solving and process improvement.
- Strong analytical skills capable of making data-driven decisions and applying risk management effectively.
Why us
We offer a dynamic environment where you can contribute meaningfully collaborate with exceptional minds and unlock your full potential.
Heres what sets ten23 apart:
Heres what sets ten23 apart:
- A valuable and impactful career development opportunity in an inspiring environment
- Flexible working arrangements and environment with an open culture and diverse workforce
- The opportunity to work with and learn from highly qualified and experienced employees
- Our learning and self-developing culture offers a wide range of training options
- Competitive pension fund plan annual bonus and other financial and non-financial benefit
Contact
For more information and clarification please connect Amrith () from our Talent team!
About us
While most applicants fall short of 100% qualifications we embrace diverse perspectives and encourage applications from all qualified candidates regardless of background. Women & underrepresented groups we see you!
Join Us & Make a Difference! ten23 champions equal opportunity and is committed to diversity and inclusion.
Learn about ten23
Join Us & Make a Difference! ten23 champions equal opportunity and is committed to diversity and inclusion.
Learn about ten23
Key Skills
About Company
The partner of choice for the pharmaceutical industry and biotech start-ups for the development, manufacture, and testing of tomorrow’s medicines.