Quality Manager, Weekend Day Shift

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 is designed to supervise Weekend Day shift personnel. Weekend Day is Friday, Saturday, and Sunday (7:00 AM to 7:30 PM). Candidates must demonstrate availability and flexibility for occasional support outside of the standard shift hours.
• 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 time frames.
• 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.