Provide strategy, oversight and tactical support of APMC Data Management business activities including the execution of operations within regulatory systems
Job Summary
Provide strategy, oversight and tactical support of APMC Data Management business activities including the execution of operations within regulatory systems.
Lead the team to achieve goals and resolve complex issues, applying sound judgment and a risk-based approach to ensure compliance.
Communicate current status to relevant business units and collaborate closely with CMC, Supply Chain, and Quality teams to align priorities.
Matching Summary
Provide strategy, oversight and tactical support of APMC Data Management business activities including the execution of operations within regulatory systems.
Skills & Requirements
Must-have
Veeva Vault RIM operations
SAP Batch Release Hub configuration
Change Control Restriction Management
Authorized Supply Chain Maps operations
eCTD and CTD Module 3 data assessment
21 CFR Part 11, EU Annex 11 knowledge
GMP standards compliance
Nice-to-have
Influence cross-functional areas
Build strong relationships
Focus on customer and partner needs
Collaborative mindset
Continuous improvement drive
Key Requirements
Minimum 7 years experience in biopharmaceutical industry
Minimum 1-2 years people management experience
Bachelor's degree in Pharmaceutical Sciences, Chemistry, or related discipline