Vice President Quality Assurance

Our client, a global biotechnology company, is seeking a Vice President of Quality Assurance. This individual will work with the leadership team to set a clear vision and strategy for the Quality Department. The role is responsible for leading, managing and coordinating Quality functions related to clinical and commercial products.

Key Responsibilities

• Oversee environmental monitoring program.
• Develop and administer the Quality Department budget and hiring plan in line with corporate goals and objectives.
• Ensure products are tested in accordance with cGMP and meet quality release specifications.
• Lead team in continuous improvement activities and take control when faced with adversity while incorporating team input.
• Ensure analytical and microbiology laboratories, compendial test methods, and routine operations are established and suitable to support GMP product testing.
• Maintain required knowledge and compliance of applicable regulations and government, industry, and company GMP and GCP standards and their interpretations.
• Serve as the main point of contact for FDA and other regulatory authorities with respect to Quality and inspections.
• Establish strategic succession planning for all areas within the Quality Department.
• Oversee the staff training program across the organization in accordance with GMP, including periodic review, and internal audits of operator training.
• Ensure facility, operations and Quality Management System are in a constant and consistent state of compliance with cGMPs.
• Develop and manage a Quality Assurance program to ensure the organization’s manufacturing operations, infrastructure, staff, practices, systems, and policies meet internal requirements and regulatory expectations.
• Oversee the establishment of departmental goals, KPIs, strategic initiatives, and priorities for the Quality Department.
• Oversee Quality decision making and liaise between the Quality Department and executive leadership.

Qualifications:

• Bachelor Degree in Physical Science, Chemistry or Life Science required
• Excellent and proven decision making, problem solving and analytical skills.
• Cross-functional experience.
• Expert knowledge of cGMP requirements, specific to pharmaceutical industry experience required.
• 15 or more years of cross-functional Quality experience supporting GMP manufacturing (Pharmaceutical, Biotech, Medical Device industry)
• MS or PhD degree in the field of Science preferred
• Team orientation/strong team player.
• Excellent communication and interpersonal skills.
• Action oriented/drives for results.
• Detail-oriented with the ability to work under tight deadlines.
• Experience building quality management systems, processes and procedures
• 10 or more years in a management role, preferably managing a team of 10 or more employees
• Strong working knowledge of FDA and EU requirements and guidance documents.

If you meet the above qualifications and would like to learn more about this opportunity, please click "Apply" or send your resume directly to Bryan Forrest at [email protected].

Thank you!