Associate Director of QA Operations

QA Operations Associate Director

INCOG Biopharma Services in Indianapolis, IN is hiring Quality Assurance Operations Associate Director. This individual will play a key role in driving the organization’s Quality Mindset and fostering a culture of efficiency, precision, and timely delivery. Working closely with the Director of Quality Assurance, the Operations Manager, and Manufacturing Science and Technology (MSAT) teams, this role will focus on strengthening operational performance while ensuring consistent adherence to quality standards.

The successful candidate will navigate audits effectively, identifying and addressing operational and quality gaps to support continuous improvement efforts.

With a strong emphasis on collaboration, the QA Operations Associate Director will cultivate positive, customer-centric relationships with internal teams, customers, suppliers, and partners. This role requires exceptional interpersonal skills and the ability to communicate complex issues clearly and concisely to a variety of stakeholders, both in written and oral formats.

A strong team player, the QA Operations Associate Director will also excel in working independently, leveraging superior self-management and organizational skills. They will recognize the value of process owners and subject matter experts and will demonstrate the ability to influence positive outcomes, even without direct reporting authority.

There is a growing need globally for more CDMOs (contract development and manufacturing organization) in the pharmaceutical industry to provide comprehensive services from drug development through drug manufacturing.

At INCOG, they are more than just a CDMO. A better way to create more meaningful experiences. A better way to create a culture that everyone can thrive and succeed in. At their core, that is who they are—a dedicated team that believes they can always be better.

Join the team at INCOG, a world-class CDMO for parenteral injectable drugs, shaping a new future for patients, for yourself, and INCOG’s clients.

• Lead and manage a QA Operations group across three shifts, 24/5, ensuring effective resource allocation to meet production timelines and quality standards.
• Train, mentor, and develop the QA team, focusing on gowning, contamination controls, aseptic processes, and equipment verifications to ensure a competent and engaged workforce.
• Prioritize and coordinate QA resources to balance production needs with product quality assurance, ensuring rigorous quality work standards and consistent product manufacture.
• Lead strategy and direction of the QA team to collaborate with Operations in on-the-floor batch record review, correction, and continuous improvement of quality processes.
• Develop and maintain room/line clearance processes for formulation, aseptic filling, and inspection/packaging areas to ensure operational efficiency and quality compliance.
• Manage deviation investigations as a subject matter expert, utilizing root cause analysis and risk mitigation tools to resolve issues and prevent recurrence.
• Stay updated on regulatory trends, leveraging continuous education, networking, and industry resources to ensure compliance with evolving regulations and best practices.
• This role has scope to be Associate Director level for the candidate with the right experience.

• Bachelor’s Degree required;
  Preferably in Science (Chemistry, Biology, Biochemistry, Microbiology etc.).
• Minimum of 8 years of Quality Assurance experience in biopharma aseptic manufacturing industry.
• 5+ years of experience as a people leader or supervisor.
• Isolator-based aseptic processing experience.
• Expert level of understanding and oversight of contamination controls, drug product manufacturing processes, and output quality. Prior experience and comfort with making risk-based decisions to ensure product quality is required.

• Advanced Degree.
• Certification(s) in Risk Management, Quality Process Analysis, Technical Writing, and/or Quality Investigation.
• Hands-on experience with aseptic manufacturing Quality.
• First-…