Senior Manager, APMC Data Management

Senior Manager, APMC Data Management - Provide strategy, oversight and tactical support of APMC Data Management business activities including the execution of operations within regulatory systems, configuration activities, and data assessments. Lead teams effectively in fast-paced, regulated environments and influence cross-functional areas to achieve objectives.

Requirements

• Lead teams effectively in fast-paced, regulated environments
• Influence cross-functional areas to achieve objectives and communicate challenging goals
• Make and implement decisions balancing speed, quality, and risk
• Build strong relationships across matrix teams and global stakeholders through transparency and reliability
• Focus on customer and partner needs, incorporating stakeholder feedback
• Understand Biologics, Pharmaceutical, and/or Cell Therapy operations and processes
• Assess data accuracy between manufacturing and regulatory information using SAP, eCTD, and CTD Module 3
• Solid knowledge of Bills of Materials in the pharmaceutical supply chain
• Experience with quality, regulatory, or supply chain systems (e.g., Veeva RIM, Veeva QMS, SAP)
• Demonstrate initiative, accountability, and a collaborative mindset
• Apply knowledge of industry regulations (21 CFR Part 11, EU Annex 11, Data Integrity)
• Strong communication, organizational, and analytical problem-solving skills
• Fluent in English, with proven professional working proficiency in English for reading, writing and speaking for clear documentation and presentations

Benefits

• Competitive benefits
• Services
• Programs
• Flexible work environment
• Opportunities for growth and development