Vice President, Quality Assurance

Kbi Biopharma - Durham, NC

Full-time - Senior

Durham, NC

Chemical Manufacturing

About the position

The Vice President of Quality, Quality Site Head at KBI Biopharma is responsible for leading the Quality Assurance and Quality Control teams in a contract manufacturing environment focused on microbial fermentation and mammalian cell culture protein therapeutics. This role encompasses oversight of quality systems, regulatory compliance, and collaboration with various departments to ensure product quality and adherence to Good Manufacturing Practices (GMP). The individual is recognized as a subject matter expert in Quality Assurance and Quality Control, playing a key role in strategic planning and operational excellence.

Responsibilities

• Oversee and implement quality systems, standards, and procedures for inspecting, testing, and evaluating manufactured products.
• Ensure the site is inspection ready at all times.
• Collaborate with other Quality Site Heads on continuous improvement initiatives.
• Lead, assess, mentor, and develop departmental associates.
• Manage performance; ensure team meets expectations and objectives; guide the professional growth of team members.
• Contribute to long-term strategic planning as part of the senior leadership team.
• Work with internal and client teams to establish Quality strategy, define roles, and problem solve.

Requirements

• Minimum requirement is a Bachelor of Science degree in a scientific discipline with 8 years of quality management experience.
• At least 5 years' experience serving in a relevant technical management capacity required.
• A Master's degree with 6 years or a PhD with 4 years of quality experience would be considered.
• At least 15 years of regulated pharmaceutical industry experience.
• Thorough knowledge of cGMPs and biotechnology-derived product regulations.
• Demonstrated track record in regulatory inspection management.
• Strong orientation for Quality and Customer Service.
• Strong collaboration and team building skills.

Nice-to-haves

• CMO experience preferred.
• Experience developing, implementing, and executing strategic plans and objectives for organizations and departments.

Benefits

• KBI Biopharma is committed to providing a safe and healthy workplace.
• EEO/AA employer actively seeking to diversify its workforce.