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
- 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:
- 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
At ten23 we believe in self-responsibility and mutual trust. Therefore we will provide our employees as much flexibility as possible and limit any bureaucracy to a minimum whilst ensuring compliance with all applicable laws.
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
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 ...
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
- 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:
- 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
At ten23 we believe in self-responsibility and mutual trust. Therefore we will provide our employees as much flexibility as possible and limit any bureaucracy to a minimum whilst ensuring compliance with all applicable laws.
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
View more
View less