Quality Assurance Operations Manager

The Associate Director of QA Operations 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 Associate Director of QA Operations 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 Associate Director of QA Operations 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.

Essential Job Functions:

• Lead and manage a QA Operations group\u202facross three shifts, 24/5, ensuring effective resource allocation to meet production timelines and quality standards.
• Ensure compliance with quality standards, cGMPs, and regulatory requirements\u202fby applying expertise to maintain inspection-readiness and serve as a key point of contact during audits.
• 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\u202fto balance production needs with product quality assurance, ensuring rigorous quality work standards and consistent product manufacture.
• Lead strategy and direction of the QA team\u202fto collaborate with Operations in on-the-floor batch record review, correction, and continuous improvement of quality processes.
• Develop and maintain room/line clearance processes\u202ffor formulation, aseptic filling, and inspection/packaging areas to ensure operational efficiency and quality compliance.
• Manage deviation investigations\u202fas a subject matter expert, utilizing root cause analysis and risk mitigation tools to resolve issues and prevent recurrence.
• Ensure safety compliance\u202fby partnering with EH&S and Operations to communicate expectations, assess behaviors, and enforce SOPs, compliance, and quality guidelines.
• Utilize paper and automated systems (Veeva, SCADA, BMS, CMMS, LIMS, etc.)\u202fto ensure data integrity and maintain accurate batch records and site policies.
• Stay updated on regulatory trends, leveraging continuous education, networking, and industry resources to ensure compliance with evolving regulations and best practices.

Special Job Requirements:

• Bachelor's Degree required; degree preferred to be in Science (Chemistry, Biology, Biochemistry, Microbiology etc.).\u202f
• Minimum of 8 years of Quality Assurance experience in biopharma aseptic manufacturing industry.\u202f
• Isolator-based aseptic processing experience.\u202f
• 5+ years of experience as a people leader or supervisor.\u202f
• 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.\u202f
• Possesses excellent working knowledge, understanding, and experience with practical implementation of FDA, EMA, and other regulatory authority expectations for Operations and Quality.\u202f
• Exceptional computer skills evidenced by hands-on work with computerized Operations equipment (SCADA); and reporting and data analysis software (Word, Excel, Visio, JMP, Minitab, etc.).\u202f

Additional Preferences:

• Advanced Degree.
• Certification(s) in Risk Management, Quality Process Analysis, Technical Writing, and/or Quality Investigation.\u202f
• Hands-on experience with aseptic manufacturing Quality.\u202f
• First-hand experience participating in and/or hosting operation floor inspection tours related to Quality Assurance.\u202f
• Experience with building processes and procedures.\u202f
• Experience with Continuous improvement, Six Sigma, and/or Lean principles.\u202f

Additional info about INCOG BioPharma Services:

At INCOG BioPharma we have built a world-class CDMO for parenteral injectable drugs. Our culture and priorities are different by design: focused on building long-term value for our customers, we are committed to a service-culture mindset, technical excellence, and a collaborative and team-centered approach to doing business.

If you crave the challenge of creating systems from scratch and believe you have insights for a better way of doing business, which benefits customers by ensuring quality outcomes and accelerating their route to market, we want to hear from you. Unless otherwise specified, all positions are based out of our Fishers, IN offices. Please note, we are a smoke-free campus.

INCOG BioPharma is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. \u202fAll employment decisions at INCOG BioPharma are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, sex (including pregnancy), age, physical disability, sexual orientation, family or parental status, or any other status protected by the laws or regulations in the locations where we operate. We will not tolerate discrimination or harassment based on any of these characteristics.

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