The Fountain Group is a national staffing firm and we are currently seeking a ­­­­­­­­Senior Manufacturing Quality Manager - Pharma for a prominent client of ours.  This position is in Rochester, NY 14623 Details for the position are as follows:

Senior Manufacturing Quality Manager – Pharmaceutical

Location: Rochester, NY
Pay: $61–$66/hour
Industry: Pharmaceutical / Biotech Manufacturing

Position Summary

We are seeking an experienced Manufacturing Quality professional to provide Quality Assurance oversight and serve as a key Quality SME supporting pharmaceutical manufacturing operations in Rochester, NY.

This position will work closely with manufacturing teams to ensure product quality, GMP compliance, and effective resolution of manufacturing-related quality issues. The ideal candidate has strong, hands-on experience supporting pharmaceutical or biologic manufacturing and understands how products move through compounding, filling, packaging, testing, and final lot release.

Experience with aseptic/sterile manufacturing, external/third-party manufacturing, and ophthalmic or eye care products is highly preferred but not required. Candidates with strong Manufacturing QA experience supporting biologics, injectables, or other regulated pharmaceutical products are encouraged to apply.

Key Responsibilities

• Provide hands-on Quality Assurance oversight for GMP manufacturing operations.
• Serve as a Quality SME and partner with manufacturing teams on product quality, compliance, and operational issues.
• Support investigations of manufacturing and, when applicable, aseptic/sterile processing events, including hands-on assessments, root cause analysis, and corrective actions.
• Provide Quality oversight throughout manufacturing activities including compounding, filling, packaging, testing, and product release.
• Review manufacturing documentation and support final quality disposition/release of manufactured product lots.
• Identify, assess, prioritize, and mitigate manufacturing and product-quality risks.
• Make recommendations regarding product quality, GMP compliance, and regulatory conformance issues.
• Partner with internal manufacturing sites, external manufacturers, Quality, Technical Operations, Regulatory, and other cross-functional teams.
• Support product transfers, manufacturing changes, new product launches, and continuous improvement initiatives.
• Support CAPAs, deviations, exception documentation, investigations, and quality trend assessments.
• Participate in GMP audits, inspection readiness activities, due diligence, and regulatory inspection preparation.
• When supporting external manufacturers, maintain productive relationships with third-party Quality organizations and help ensure Quality and Technical Agreement commitments are met.
• Promote manufacturing and aseptic best practices based on company standards and current industry expectations.

Qualifications

• Bachelor's degree in Life Sciences, Engineering, Pharmaceutical Sciences, Chemistry, Biology, or another relevant technical discipline; equivalent relevant industry experience may also be considered.
• Approximately 7+ years of pharmaceutical, biotechnology, medical device, or other highly regulated manufacturing/Quality experience preferred.
• Strong experience in Quality Assurance supporting GMP manufacturing operations.
• Demonstrated understanding of pharmaceutical manufacturing processes and how products are manufactured, filled, packaged, tested, and released.
• Experience working directly with manufacturing teams and resolving shop-floor Quality issues.
• Strong analytical, investigation, root-cause, and problem-solving skills.
• Ability to independently operate as a Quality leader/SME and manage multiple priorities in a fast-paced manufacturing environment.
• Strong communication skills with the ability to work across Quality, Manufacturing, Technical Operations, and other functional groups.

Highly Preferred Experience

• Aseptic or sterile manufacturing
• Sterile fill/finish or injectable manufacturing
• Ophthalmic / eye care or aesthetics product manufacturing
• Biologics manufacturing
• CMO/CDMO, third-party, or external manufacturing Quality oversight
• Batch disposition and final lot release
• Aseptic event/deviation investigations
• Shop-floor Manufacturing QA
• Quality or Technical Agreements
• Product transfers and new product launches
• FDA inspection or pre-approval inspection readiness

Most important: This position requires genuine GMP manufacturing Quality experience. Candidates should have experience directly supporting manufacturing operations rather than primarily working in document control, Quality Systems, auditing, or administrative CAPA management.

By applying for this job, you agree to receive calls, AI-generated calls, text messages, or emails from and its affiliates, and contracted partners. Frequency varies for text messages. Message and data rates may apply. Carriers are not liable for delayed or undelivered messages. You can reply STOP to cancel and HELP for help. You can access our privacy policy at Privacy Policy

#LI-ML1