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Director of QA
2 months ago
Job Title: Director of Quality Assurance (QA)
Location : United Kingdom (On-site)
I am partnered with a growing 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.
Job Overview:
We are seeking an experienced and strategic-minded Director of Quality Assurance (QA) to lead our UK QA team. This role is pivotal in ensuring that our operations comply with Good Manufacturing Practice (GMP) and Good Laboratory Practice (GLP) standards. The Director of QA will be responsible for overseeing quality audits, managing data transformation initiatives, and maintaining an effective Quality Management System (QMS). The successful candidate will have a strong background in QA within the pharmaceutical or biotechnology sectors, with proven leadership abilities to guide and develop a team of 7 QA professionals.
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.
GMP & GLP Compliance:
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.
Qualifications & Experience:
Bachelor's degree in a relevant scientific discipline; advanced degree preferred.
Minimum of 10 years of QA experience in the pharmaceutical or biotechnology 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.
Strong leadership, communication, and interpersonal skills, with the ability to influence at all levels of the organization.
Experience in a CDMO environment is highly desirable.
Key Competencies:
Strategic thinking with the ability to develop and execute QA plans that align with business goals.
Excellent problem-solving skills and attention to detail.
Ability to work in a fast-paced, dynamic environment, managing multiple priorities effectively.
Commitment to continuous improvement and innovation in quality processes.
