Vice President of Quality

4 weeks ago

London, UK, United Kingdom Hlx Life Sciences Full time

Hlx Life Sciences are working exclusively with an existing partner on a retained search for a Vice President of Quality in the UK. Please see further details below:


Job Summary:

The Vice President of Quality will be a pivotal leader within our partners organisation, a clinical-stage biotechnology company focused on the development of innovative ATMP's. The VP of Quality will oversee the entire Quality function, ensuring compliance with global regulatory standards and delivering high-quality products from preclinical stages through clinical development and commercial launch. The successful candidate will build and scale the quality management systems (QMS) to support the company’s growth, while fostering a culture of quality and operational excellence.


This role requires a seasoned leader with deep expertise in GMP, GLP, and GCP environments, as well as the regulatory requirements surrounding advanced therapies. The VP of Quality will collaborate cross-functionally, working closely with R&D, Manufacturing, Regulatory Affairs, and Clinical Operations to ensure that all activities meet regulatory and quality standards.


Key Responsibilities:

Quality Leadership and Strategy:

  • Lead the development, implementation, and continuous improvement of the company’s Quality vision, strategy, and goals to support the development and commercialization of cell and gene therapy products.
  • Build and manage the Quality Assurance (QA), Quality Control (QC), and Compliance functions.
  • Partner with executive leadership to establish strategic priorities related to quality operations and regulatory compliance.

Quality Management Systems:

  • Oversee the development, maintenance, and scaling of robust Quality Management Systems (QMS) to ensure compliance with regulatory standards (FDA, EMA, ICH, and other global agencies).
  • Ensure compliance with Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and Good Clinical Practices (GCP) across all stages of product development.
  • Ensure appropriate validation and qualification activities are performed, including facilities, equipment, processes, and computer systems.

Regulatory Compliance and Inspection Readiness:

  • Provide strategic oversight for all quality-related aspects of regulatory filings (e.g., IND, BLA, MAA) and inspections.
  • Lead the company’s preparations for regulatory agency inspections and audits (FDA, EMA, etc.), and ensure continued inspection readiness.
  • Drive the organization’s response to inspection findings and implement corrective and preventive actions (CAPA) as necessary.

Quality Assurance and Control:

  • Ensure robust oversight of quality assurance and control activities across internal and external manufacturing and testing sites.
  • Establish quality metrics and KPIs to monitor performance and drive continuous improvement.
  • Lead efforts to review, approve, and release clinical trial materials (CTM) and future commercial products.

Cross-functional Collaboration:

  • Collaborate with the R&D, Manufacturing, Regulatory, and Clinical teams to ensure seamless integration of quality processes across the organization.
  • Provide input into product development and clinical trial design to ensure quality is embedded from the start.
  • Serve as a key advisor to the executive team, ensuring that quality is prioritized in decision-making and operational activities.

Leadership and Team Development:

  • Build, lead, and mentor a high-performing Quality team, driving a culture of accountability and operational excellence.
  • Promote continuous learning and development of team members, ensuring the Quality organization is prepared to support growth and scale.


Qualifications:

  • Education: Bachelor’s degree in life sciences, biotechnology, engineering, or a related field. Advanced degree (MS, PhD, or MBA) preferred.
  • Experience:
  • 15+ years of experience in the biopharmaceutical or biotechnology industry, with a focus on Quality Assurance, Quality Control, or Regulatory Affairs.
  • Significant experience with cell and gene therapy products, or other advanced therapies is strongly preferred.
  • Proven leadership experience in a clinical-stage or commercial-stage biotech or pharmaceutical company.
  • Expertise in FDA, EMA, and ICH regulations, particularly related to GMP, GCP, and GLP for advanced therapies.


Apply now to find out more

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