Director of Quality Assurance and Compliance

7 days ago

London, Greater London, United Kingdom Barrington James Full time
Job Title: Director of Quality Assurance and Compliance

Barrington James is seeking an experienced and strategic-minded Director of Quality Assurance and Compliance to lead our UK QA team.

Job Summary

We are a leading Contract Development and Manufacturing Organization (CDMO) committed to delivering high-quality services to our global pharmaceutical and biotech clients. We specialize in providing end-to-end solutions from development through commercialization, with a strong focus on regulatory compliance, innovation, and customer satisfaction.

Key Responsibilities
  • Leadership & Team Management:
    • Lead, mentor, and develop a team of 7 QA professionals, fostering a culture of continuous improvement and high performance.
    • Provide strategic direction to the UK QA team, aligning with global QA objectives and regulatory requirements.
  • Quality Assurance:
    • Ensure all operations within the UK site comply with GMP and GLP standards, maintaining the highest levels of product quality and safety.
    • Oversee the implementation and maintenance of robust quality systems to ensure compliance with applicable regulations and industry best practices.
  • Quality Audits:
    • Plan, conduct, and oversee internal and external quality audits to assess compliance with regulatory requirements and identify areas for improvement.
    • Collaborate with regulatory agencies, clients, and internal teams to prepare for and respond to audits and inspections.
  • Data Transformation:
    • Lead data transformation initiatives to enhance quality processes, leveraging technology and data analytics to improve efficiency and accuracy.
    • Ensure the integrity and reliability of quality-related data across all operations.
  • Quality Management System (QMS):
    • Manage and continuously improve the QMS, ensuring it supports the organization's strategic goals and complies with regulatory standards.
    • Develop and implement quality policies, procedures, and metrics to drive continuous improvement and operational excellence.
  • Regulatory & Client Liaison:
    • Serve as the primary point of contact for regulatory bodies and clients on all QA-related matters.
    • Ensure timely and effective communication with stakeholders, addressing any quality issues or concerns.
Requirements
  • Bachelor's degree in a relevant scientific discipline.
  • Minimum of 10 years of QA experience in the pharmaceutical or biotech industry, with at least 5 years in a leadership role.
  • Extensive knowledge of GMP, GLP, and regulatory requirements.
  • Proven track record in managing quality audits, QMS, and data transformation initiatives.
  • Commitment to continuous improvement and innovation in quality processes.

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