Vice President of Quality

Job Description

The Vice President of Quality plays a pivotal role in ensuring the highest standards of quality and compliance within pharmaceutical operations. Emphasizing adherence to GMP regulations, VP of Quality will lead the Quality Assurance and Quality Control teams and collaborate with cross-functional departments to drive continuous improvement initiatives.

Responsibilities:

• Hosting FDA & EU audits and inspections
• Oversight of Quality Systems and Quality Documentation teams
• Implementation and continuous improvement of the company’s quality systems and facility validation
• Oversight of a broad range of documentation
• Work with cross-functional teams to troubleshoot equipment, process, and validation issues
• Support clinical and commercial operations
• Facility validation activities
• Building and leading the Quality Assurance and Quality Control groups

Duties and 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.
• Supervisory Responsibilities:
• Provides leadership to the Quality Assurance and Quality Control departments.
• Recruits, interviews, hires and trains new staff.
• Oversees daily workflow of the department.
• Provides constructive and timely performance evaluations.
• Handles discipline and termination of employee in accordance with company policy.

Education and Experience:

• 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.