Mantell Associates is partnered with a biopharmaceutical company developing novel cellular and biologics therapeutics for unmet clinical needs. They are seeking a Director of Quality Systems to lead the QA strategy for the company.

Director of Quality Systems – Responsibilities:

• Develop quality policies, annual goals, and objectives in alignment with company goals and objectives
• Establish and maintain risk-based and fit-for-purpose quality management system (QMS) ensuring effective implementation, which is managed and continuously improved to sustain compliance with internationally recognized standards
• Establish and manage departmental goals compatible with corporate objectives and program milestones
• Provide expertise for Manufacturing, Development, Clinical and other internal departments to develop processes/procedures related to quality assurance activities for GXP (GTP, GMP, GLP and GCP) compliance and ensure compliance in all areas
• Develop processes and procedures for the selection and management of third-party service providers (e.g., contract manufacturers, testing laboratories) to ensure expectations for quality and compliance are documented and met
• Develop, implement and maintain quality systems for lot release, training and tracking discrepancies, investigations, audits, change control, etc.
• Manage the controlled document system; review and approve operating procedures for GXP operations
• Direct the supplier quality program to ensure R&D, manufacturing, and service providers are classified for risk
• Conduct supplier audits and assessments
• Establish quality agreements with critical suppliers
• Host regulatory inspections and coordinate responses to findings

Director of Quality Systems – Requirements:

• 10+ years of pharmaceutical or biotechnology experience and broad range of knowledge in quality assurance, quality control, and regulatory, preferably with cell based-therapeutics
• BA/BS/PhD in life sciences or related field
• Advanced degree desirable, but not required
• Experience implementing quality assurance systems in a GMP environment, and direct experience with vendor audits and inspections
• Extensive knowledge of GXP compliance regulations and industry
• Strong leadership and management
• Demonstrated ability to successfully lead team and develop employees
• Excellent communication skills (verbal, written, and presentation) that facilitate strategy deployment to all levels of the organization
• Demonstrated ability to partner/collaborate with other functional group to achieve business objectives

Mantell Associates is a specialist Pharmaceutical and Life Science headhunting firm. For more information on this opportunity, contact us at +44 (0)20 3854 7700.

Tagged as: Quality