Product Manager, Annual Product Reviews (Pharma QA)

Catalent, Inc.; Winchester (VA); Sur place; USD 90 000 - 130 000; Plein temps

Avantages offerts par ce poste

Medical, dental, vision benefits

Tuition Reimbursement

Paid time off + holidays

Wellness programs

Résumé du poste

Catalent, Inc. in Winchester, KY is seeking a Product Manager for Annual Product Reviews to verify process consistency, assess trends, and determine changes in specifications and controls.

You will be the SME for APRs and partner with internal teams and clients to ensure quality and regulatory compliance. The role requires cross-functional coordination, data analysis from batch records and COAs, and support for FDA and other agency inspections.

Qualifications

• Bachelor of Science in a pharmaceutical field or equivalent hands-on experience.
• Five years of quality and/or regulatory experience in the pharmaceutical industry, or seven years in a regulated industry.
• Ability to communicate effectively at all levels of internal and client organizations and regulatory agencies.
• Proficiency in Microsoft Word, Excel, and PowerPoint.

Responsabilités

• Author Annual Product Reviews to verify process consistency and assess trends.
• Serve as the SME for Annual Product Reviews for clients and internal customers.
• Coordinate with Validation, Technical Writers, QA, QC, Product Development and Customer Service.
• Support audits and regulatory inspections and ensure audit readiness.
• Maintain Quality System health and ensure adherence to SOPs and cGMP.

Connaissances

Effective communication

Cross-team collaboration

Regulatory knowledge

Formation

Bachelor of Science in pharmaceutical field

Outils

Minitab

PowerBI

Trackwise

JD Edwards

Description du poste

Catalent, Inc. in Winchester, KY is seeking a Product Manager for Annual Product Reviews to verify process consistency, assess trends, and determine changes in specifications and controls.

You will be the SME for APRs and partner with internal teams and clients to ensure quality and regulatory compliance. The role requires cross-functional coordination, data analysis from batch records and COAs, and support for FDA and other agency inspections.