Senior Manager, APMC Data Management

key roles and responsibilities:

• Provide strategy, oversight and tactical support of APMC Data Management business activities including the execution of:
• Operations within regulatory systems such as Veeva Vault RIM, Quality Veeva Systems, and Regulatory Content Repositories, including extraction and review of submission registrations.
• Configuration activities within SAP Batch Release Hub including but not limited to product release test configuration, customer release check management, and issue resolution.
• Configuration activities within Change Control Restriction Management including but not limited to review of CMC assessments, confirmation and management of digital documents, data entry for alliance partner CMC assessments, and system configuration activities.
• Operations within Authorized Supply Chain Maps including but not limited to document extraction configuration, exception/issue handling and data entry.
• Operations within Document Data Extraction including but not limited to document extraction configuration, exception handling and data entry.
• Data assessments from eCTD and CTD Module 3 documents to ensure accuracy, completeness, and consistency with relevant information from Quality and Supply Chain functions
• Proactively manage risk and implement contingency plans to address uncertainty.
• Lead the team to achieve goals and resolve complex issues, applying sound judgment and a risk-based approach to ensure compliance.
• Develop, track, and adjust KPIs to identify and mitigate risks impacting business objectives.
• Monitor trends and metrics to drive continuous improvement and update contingency plans as needed.
• Communicate current status to relevant business units and collaborate closely with CMC, Supply Chain, and Quality teams to align priorities.
• Escalate unresolved deficiencies and risks to stakeholders to support timely product release.
• Identify and recommend process improvements while ensuring compliance with GMP standards and BMS policies.
• Support issue resolution across electronic systems, including Change Controls, Deviations, Restrictions Management, SAP Batch Release Hub, Authorized Supply Chain Maps, and Document Data Extraction.

Specific Knowledge, Skills, Abilities:

• 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) preferred.
• 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.

Education:

• Minimum 7 years of experience in a technical, quality, and/or regulatory role within the biopharmaceutical industry with demonstrated acumen in Quality Compliance or Operations preferred.
• A minimum of 1-2 years experience in a people management role is required.
• Bachelor s degree in Pharmaceutical Sciences, Chemistry, or a related discipline.

Travel:

Must have ability to travel abroad required (specifically for training purposes)