Product Manager

Description

• Act as the primary quality liaison for clients and internal customers, becoming the Subject Matter Expert for client products, processes, and requirements.
• Support both new and commercial products and processes.
• Assist with internal, client, and regulatory audits.
• Maintain systems and procedures to monitor quality system health and ensure audit readiness on client manufacturing floors.
• Perform statistical analyses and provide routine metrics for customers.
• Represent Quality in Quality Business Update meetings.
• Maintain and develop client partnerships to ensure alignment and consensus.
• Coordinate internal QA functions with customers and Catalent departments, including reviewing and closing investigations, handling non-critical customer complaints, trending product data, approving qualification reports, writing and revising Quality Agreements, and reviewing Annual Product Review/Annual Quality Review sections.
• Maintain client data sets including metrics, trackers, business review material, and updates to leadership teams.
• Interface with Operations and Customer Service to maintain partnerships for third-party manufacturing and ensure compliance.
• Coordinate key systems such as Customer Complaints and other quality-related functions for assigned products and clients.
• Perform other duties as required to support high performance.

Qualifications

Highest qualification: University

• High school diploma or GED required.
• 5+ years of experience in quality and/or regulatory in the pharmaceutical industry OR 7+ years in a regulated industry with understanding of lab, manufacturing, regulatory, and compliance.
• Ability to communicate successfully at all levels of internal and client organizations and regulatory agencies.
• Proven ability to work independently.
• Knowledgeable in auditing principles and able to audit/evaluate manufacturing and support functions for audit preparedness.
• Self-motivated with strong organizational skills.
• Highly developed documentation skills.
• Openly shares information, values feedback, and communicates directly.
• Knowledge of quality, regulatory, and legal standards including USP, EP, JP, GMP, ICH, DEA, and FDA.
• Proficient in Microsoft Word, Excel, and PowerPoint; preferred experience in Trackwise and JDE.
• Ability to read, write, and speak clear English.
• Individual may be required to sit for an extended period of time.
• Specific vision requirements include reading written documents and frequent use of a computer monitor.