QA Product Manager

Shionogi Inc. (U.S.)

QA Product Manager ensuring quality assurance for pharmaceutical products in collaboration with cross-functional teams. Leading third-party manufacturing quality efforts and compliance with regulatory standards.

Posted 4/9/2026full-timeFlorham Park • New Jersey • 🇺🇸 United StatesMid-LevelSenior💰 $120,000 - $150,000 per yearWebsite

About the role

Key responsibilities & impact

Lead Quality Assurance efforts for pharmaceutical products manufactured by third-party manufacturers
Develop and Implement Quality Assurance strategies, policies, and procedures specific to third-party manufacturing
Conduct rigorous assessments and audits of potential and existing third-party manufacturers
Oversee and provide guidance on the design and execution of validation
Provide technical guidance and support to third-party manufacturers regarding quality systems
Collaborate with Regulatory Affairs teams to support product registrations
Resolve quality issues and initiate investigations
Perform batch record review and communicate adverse findings
Manage the development of product specifications and sterility assurance practices
Review and approve stability protocols and results

Requirements

What you’ll need

Bachelor's degree in Life Sciences (Biology, Microbiology, Pharmacy, Pharmaceutical Sciences, Chemistry, or a related field)
Minimum of five (5) years of experience in pharmaceutical Quality Assurance, with experience in third-party manufacturing
Sterile experience a plus
Strong project management skills
Excellent communication and interpersonal skills
Experience with quality management software and tools such as Veeva
Knowledge of pharmaceutical product development processes, supply chain management, and regulatory requirements for third-party manufacturing

Benefits

Comp & perks

Health insurance
401(k) matching
Paid time off
Flexible work arrangements
Professional development opportunities

ATS Keywords

✓ Tailor your resume

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

Quality AssuranceValidationBatch record reviewProduct specifications developmentSterility assurance practicesStability protocols reviewAuditingInvestigationsRegulatory compliancePharmaceutical product development

Soft Skills

Project managementCommunicationInterpersonal skills