Mantell Associates is partnered with an industry-leading drug development CDMO, in their search for a Vice President (VP) of Quality who will play a pivotal role in ensuring the highest standards of quality and compliance within pharmaceutical operations.
VP of Quality - Responsibilities:
- Serve as the strategic leader to drive, direct, oversee and manage quality and compliance across all departments, and ensure that quality strategies are known and implemented
- Develop and implement a comprehensive Quality strategy to support the manufacturing, testing, and release of pharmaceutical products in accordance with GMP regulations and other relevant standards
- Identify Key Quality and Risk Indicators (KQIs/KRIs) and oversee mechanisms for detection and trending
- Oversee and manage all aspects of the Quality Management System (QMS) to ensure compliance with GMP and other applicable guidelines
- Provide strategic leadership to the Quality Assurance and Quality Control Departments, fostering a culture of excellence, accountability, and continuous improvement within the GMP framework
- Collaborate with cross-functional teams, including Product and Process Development, Manufacturing Operations, Facilities Engineering, Supply Chain and Environmental Health and Safety, to ensure seamless integration of quality processes throughout the product life cycle in alignment with GMP requirements
- Conduct risk assessments and implement proactive measures to prevent and address quality issues, deviations, and non-conformances within the GMP context
- Lead and support regulatory inspections, ensuring readiness and effective responses to inspection findings, with a focus on GXP compliance
- Establish and maintain key performance indicators (KPIs) to monitor and report on the effectiveness of the Quality Assurance program within the GXP framework
- Drive the development and execution of training programs to enhance the skills and knowledge of quality personnel and other relevant stakeholders, with emphasis on GXP principles
- Develop and implement Quality organizational goals aligned with the company's vision
- Develop and administer budgets, plans, and performance requirements linked to the quality Assurance and Quality Control departments
VP of Quality - Requirements:
- Bachelor’s or advanced degree in scientific discipline
- 15 years of progressive experience in Quality Assurance and/or Quality Control in a pharmaceutical manufacturing environment
- Past experience developing, implementing, and monitoring Quality programs, policies and procedures to ensure compliance with GMP standards, corporate policies, FDA, EMA and other regulatory body regulations and guidelines
- Requires 10 years of GMP experience and expertise
- Strong leadership and management skills
- Proven leadership experience with a track record of successfully managing and developing high-performing teams within a GMP environment
- Excellent analytical and problem-solving skills with the ability to make informed decisions in complex situations, taking GMP regulations into account
Mantell Associate is a specialist Pharmaceutical and Life Science headhunting firm. For more information on this opportunity, contact us at +44 (0)20 3854 7700.
