Shionogi Inc. (U.S.)

QA Product Manager

Shionogi Inc. (U.S.)

full-time

Posted on:

Location Type: Hybrid

Location: Florham Park • New Jersey • United States

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Salary

💰 $120,000 - $150,000 per year

About the role

  • 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

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