Job Description

Working closely with the Director of Quality, the Quality Supervisor will serve as an integrated quality leader with accountability spanning both Quality Assurance Operations and Quality Control activities. This role is instrumental in championing INCOG’s Quality Mindset and fostering a culture of efficiency, attention to detail, and on-time delivery across manufacturing and laboratory functions.

The Supervisor will need to successfully navigate and identify operational and quality gaps in both the manufacturing environment and the QC laboratory setting. They will bring a balanced technical depth across GMP manufacturing oversight, contamination control, and laboratory testing operations — ensuring seamless alignment between QA and QC functions in support of compliant, inspection-ready operations.

The Quality Supervisor will exemplify excellent interpersonal skills and develop productive, customer-centric working relationships with subordinates, colleagues, customers, suppliers, and partners. The Supervisor will demonstrate excellent written and oral communication skills, with the ability to clearly and concisely articulate complex issues to a range of audiences. The Supervisor will thrive in a team environment but will also work autonomously, leveraging strong self-management and organizational skills. They will value process owners and subject matter experts and will possess a demonstrated ability to influence positive outcomes without direct reporting authority.

This role supervises Weekend shift personnel (Friday–Sunday). Two shifts are available: Days (7:00 AM–7:30 PM) and Nights (7:00 PM–7:30 AM). Candidates must demonstrate availability and flexibility for occasional support outside of their standard shift hours.

Essential Job Functions

• Recruit, build, and lead an integrated QA Operations team; train and maintain an engaged workforce competent in the theory and application of quality processes across aseptic drug product manufacturing.
• Maintain an on-floor presence to coach, mentor, and enforce rigorous quality work standards; prioritize and coordinate QA resources to balance production timelines with product quality assurances.
• Lead development of room/line clearance processes for formulation, aseptic filling, and inspection/packaging areas; train QA personnel on gowning requirements, contamination controls, aseptic line operations, and equipment applications and verifications.
• Lead QA strategy in partnership with Operations for on-floor batch record review and correction; establish an ongoing state of readiness for rapid decision-making in the evaluation of deviating events, product segregation requirements, and implementation of initial corrective actions.
• Partner with EH&S and Operations management to communicate safety expectations, assess safety behaviors, practice positive intervention, and enforce best practices aligned to SOPs, compliance requirements, and site goals.
• Provide technical support, oversight, and team leadership for QC Chemistry, Microbiology, and QC Technical Services; oversee daily QC activities to ensure testing and data review is completed within appropriate timeframes.
• Deliver daily expectations and assignments to QC personnel; provide in-lab support as needed for routine and on-demand testing.
• Develop QC team members through mentorship to analysts and data reviewers; communicate with Quality Control Leadership on team performance.
• Support deviation investigations, laboratory investigations, and CAPA implementation spanning both manufacturing and laboratory quality events; develop and improve current processes to maintain and control general QC functions.
• Conduct laboratory walk-throughs to ensure inspection readiness and cGMP compliance across all QC laboratory operations.
• Continuously evaluate processes and procedures across QA and QC functions to create a productive environment while maintaining the highest possible quality standards; ensure all work is carried out in accordance with regulatory requirements, cGMP, and SOPs.
• Influence the accomplishment of company-wide and team goals; inspire team members while consistently modeling ALP values in all interactions.

Special Job Requirements

· Bachelor's Degree required; Science discipline preferred (Chemistry, Biology, Biochemistry, Microbiology, or related field).

· Minimum of 5 years of cGMP experience in biopharma or a similarly regulated industry, including at least 2 years in a Quality Assurance capacity.

· Working knowledge of QC Microbiology and/or Chemistry, GxP principles, CAPA/investigation management, data/document review, and relevant quality and regulatory requirements.

· Working knowledge of contamination controls, manufacturing processes, and output quality across automated and non-automated systems, including associated data integrity requirements.

· Demonstrated experience making risk-based decisions to ensure product quality.

· Knowledge of aseptic techniques and processing.

· Strong communication and relationship-building skills across all levels of the organization, including operations, quality, and business leadership.

Additional Preferences

• Advanced Degree.

• Certification(s) in Risk Management, Quality Process Analysis, Technical Writing, and/or Quality Investigation.

• Hands-on experience with aseptic manufacturing Quality, including isolator based processing.

• 3 to 5 years of demonstrated working knowledge of GMP laboratory operations (QC Chemistry and/or Microbiology).

• 2+ years of experience as a people leader or supervisor.

• First-hand experience participating in and/or hosting operational floor inspection tours related to Quality Assurance.

• Experience building processes and procedures.

• Experience with Continuous Improvement, Six Sigma, and/or Lean principles.

Additional Information 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. All 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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