Product Manager II

The Quality Assurance Manager will serve as the primary quality lead for Third-Party Manufacturing (TPM) activities, providing quality and compliance oversight for aseptic manufacturing operations, product transfers, investigations, audits, and new product launches. This role will partner closely with TPMs, internal manufacturing sites, and cross-functional teams to ensure product quality, regulatory compliance, and timely delivery of quality objectives.

The Fountain Group is currently seeking a QA Product Manager for a prominent client of ours. This position is located in Rochester, NY. Details for the position are as follows:

 

Job Description:

• Hybrid Work Schedule
• Pay Range $61.00-$66.00 Per Hour 
• The Quality Assurance Manager will serve as the primary quality lead for Third-Party Manufacturing (TPM) activities, providing quality and compliance oversight for aseptic manufacturing operations, product transfers, investigations, audits, and new product launches.
• This role will partner closely with TPMs, internal manufacturing sites, and cross-functional teams to ensure product quality, regulatory compliance, and timely delivery of quality objectives.

Qualifications:

• Bachelor’s degree in Life Sciences, technical discipline, or equivalent experience.
• 7+ years of total experience, including:
  • 5+ years in Quality Assurance and/or Aseptic Manufacturing Operations Management
  • 3+ years in Operations, R&D, or Consulting
• Strong knowledge of aseptic/sterile manufacturing and pharmaceutical or biologics manufacturing processes.
• Hands-on experience with quality investigations, aseptic events, deviations, CAPA, and quality risk management.
• Experience with final product/lot release and quality/compliance decision-making.
• Experience supporting or leading GMP audits, site approvals, due diligence, and inspection readiness.
• Ability to manage Third-Party Manufacturers and external quality organizations, including Quality/Technical Agreements.
• Strong understanding of GMP, regulatory compliance, and pharmaceutical quality systems.
• Strong analytical, problem-solving, communication, negotiation, and leadership skills.
• Ability to manage multiple complex priorities in a high-urgency environment.

Preferred Qualifications & Skills

• Experience with sterile, biologic, liquid, solid-dose, ophthalmic/eye-care, or medical device products.
• Experience supporting product transfers, new product launches, and manufacturing optimization.
• Experience with pre-approval inspections (PAIs) and regulatory inspection readiness.
• Experience reviewing Annual Product Reviews (APR) / Annual Product Quality Reviews (APQR/PQR) and quality trends.
• Experience managing external manufacturing/contract manufacturing organizations (CMOs).
• Consulting or cross-functional program/project management experience.
• Experience with nonconformance/deviation investigations, trend analysis, and CAPA management

If you are interested in hearing more about the position, please respond to this posting with your resume attached.

Please forward this posting to any friends or colleagues as we do offer a Referral Bonus for any candidate hired.

 

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