Sr. Manufacturing Quality Manager - Pharmaceutical

The Fountain Group; New York (NY); On-site; USD 84,000 - 91,000; Full time

Job summary

The Fountain Group is seeking a Senior Manufacturing Quality Manager in Rochester, NY to lead GMP quality oversight across pharmaceutical manufacturing operations. You will collaborate with manufacturing teams to ensure quality, compliance, and timely resolution of issues, including aseptic/sterile processing events and final lot release.

The role requires 7+ years in regulated manufacturing, hands-on QA expertise, and strong problem-solving as a Quality leader.

Qualifications

• Bachelor's degree in Life Sciences, Engineering, Pharmaceutical Sciences, Chemistry, Biology, or another relevant technical discipline.
• Approximately 7+ years of pharmaceutical, biotechnology, medical device, or other highly regulated manufacturing/Quality experience.
• 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.

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.

Skills

Quality Assurance

GMP compliance

Root cause analysis

Quality leadership

Cross-functional collaboration

Education

Bachelor's degree in Life Sciences/Engineering/Pharmaceutical Sciences

Job description

The Fountain Groupis a national staffing firm and we are currentlyseeking aSenior Manufacturing Quality Manager - Pharmafor a prominent clientofours.This position is inRochester, NY 14623Details for the positionare as follows:

Senior Manufacturing Quality Manager - Pharmaceutical

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

Position Summary

We are seeking an experiencedManufacturing 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 throughcompounding, filling, packaging, testing, and final lot release.

Experience withaseptic/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‑onQuality 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 includingcompounding, filling, packaging, testing, and product release.
• Review manufacturing documentation and supportfinal 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.
• Approximately7+ years of pharmaceutical, biotechnology, medical device, or other highly regulated manufacturing/Quality experience preferred.
• Strong experience inQuality 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 aQuality leader/SMEand 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 genuineGMP 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.