Director, GMP Quality Compliance (Pharmaceutical Auditor)

Job description

Job Summary:

The Director, GMP Quality Compliance position requires a strong leader as part of the Quality team to lead MEI Pharma's GMP Quality Compliance function. The Director of GMP Quality Compliance will serve as a strategic and tactical quality professional in managing GMP compliance related to contract organizations and internal processes encompassing Good Manufacturing Practices (GMPs) and Good Distribution Practices (GDPs) . This position plays a significant role in support of the vendor management program and other related activities including, but not limited to, inspection readiness, inspection management, internal audits, external audits, and due diligence. The Director of GMP Quality Compliance is responsible for ensuring oversight of compliance with FDA, EMA, and PMDA regulations and ICH guidelines applicable to GMPs and GDPs, industry best practices and internal policies and procedures. The Director of GMP Quality Compliance will be responsible for surveillance of industry trends and changing regulations and will provide ownership and oversight of continuous improvement of GMP compliance processes. The position will partner with the Manufacturing, Supply Chain, and Pharmaceutical Sciences organizations to provide strategic GDP and GMP compliance oversight for all MEI Pharma programs and internal operations.

Management Scope: Requires management of FTEs and Contractors.

Role & Responsibilities (include but not limited to):

• Lead MEI Pharma's GMP Compliance function while promoting a culture of quality by collaborating across all departments and levels of management to accomplish company objectives.
• Lead the GMP inspection management program, including pre-approval inspection readiness of vendors and suppliers, internal inspection readiness activities, inspection conduct, and preparation of responses to health authorities.
• Lead the GMP external audit program including development, maintenance and execution of the annual GMP audit plan. Partner externally to build/maintain relationships and perform effective audits of GMP vendors [contract manufacturing (CMO), laboratory (CTL), contract packaging and labeling, clinical supply depots, distribution (3PL), starting material and excipient suppliers, and computer service organizations], and ensure responses are acceptable and audits are closed in a timely manner.
• Lead the GMP internal audit program and collaborate internally to execute routine, risk-based monitoring and auditing of relevant internal GMP business activities and ensure compliance with applicable regulations, guidelines, policies and internal procedures; identify potential areas of compliance vulnerability and risk; oversee the implementation of corrective action/preventive action plans as necessary; and generate reports on monitoring, auditing and risk assessment for the business.
• Ensure that all audit observations are communicated to stakeholders, tracked and remediated in compliance with internal policies as well as with all applicable regulatory requirements.
• Facilitate the MEI Pharma field alert, recall, or product withdrawal processes and associated committees.
• Perform GMP training of internal company employees.
• Drive continuous improvement efforts and support the development and implementation of the Quality Plan to ensure MEI Pharma quality objectives are met.
• Assess new and emerging regulations and inspection trends for impact on GMP activities and apply changes in a fit for purpose manner to MEI's Quality Management System and practices.
• As required, provide performance reviews, development plans and set goals for department staff in alignment with company goals.
• This position requires travel up to 25%.

Qualifications:

• Demonstrates initiative and proactively provides collaborative support to the operational teams as a credible communicator.
• Must have excellent communication skills, a high degree of professionalism, and ability to work with limited direction to follow through with specific tasks. Continuously demonstrates a positive, 'can do' and collaborative attitude.
• Strong oral and written communicator; detail-oriented with a commitment to accuracy. Ability to plan and organize work in an efficient manner, multi-task and shift priorities quickly while working under time constraints.
• Skilled in developing collaborative internal and external relationships with experience in building teams, through coaching and development.
• Strong PC experience and demonstrated proficiency in MS Office (Outlook, Word, Excel, PowerPoint).

Education and Experience:

• BS or BA degree or equivalent in a science or health care field and significant experience in an FDA-regulated environment.
• Minimum of 15 years of experience in the pharmaceutical industry with a GMP focus, ideally covering several areas supporting commercial manufacturing operations, with 10+ years in a GMP quality role and 5+ years in a Quality Leadership role.
• Demonstrated competence in direct participation in health authority inspections is required.
• Broad knowledge of GMP processes and procedures, electronic systems that support manufacturing and testing operations, and GDP and GMP regulations and guidance with demonstrated effectiveness in maintaining audit programs.
• Appropriate training and experience in conducting quality audits of CMOs, CTLs, 3PLs, Contract Packagers, material suppliers and computer system providers.
• Proven experience handling confidential and sensitive information with the ability to exercise discretion and show good judgment; honesty, integrity, and trust building behaviors in all dealings is essential and required.