Senior Manager, APMC Data Management

This Senior Manager role involves providing strategic oversight and tactical support for APMC Data Management activities within regulatory systems like Veeva Vault RIM and SAP Batch Release Hub. Responsibilities include executing operations, configuring systems, performing data assessments for regulatory documents, managing risks, and driving continuous improvement while ensuring compliance with GMP standards and BMS policies. The role requires collaboration with CMC, Supply Chain, and Quality teams to ensure timely product release and issue resolution across electronic systems.

Must Have

• Provide strategy, oversight and tactical support of APMC Data Management business activities.
• Execute operations within regulatory systems (Veeva Vault RIM, Quality Veeva Systems, Regulatory Content Repositories).
• Perform configuration activities within SAP Batch Release Hub.
• Perform configuration activities within Change Control Restriction Management.
• Execute operations within Authorized Supply Chain Maps.
• Execute operations within Document Data Extraction.
• Conduct data assessments from eCTD and CTD Module 3 documents.
• Proactively manage risk and implement contingency plans.
• Lead teams to achieve goals and resolve complex issues.
• Develop, track, and adjust KPIs.
• Communicate status and collaborate with CMC, Supply Chain, and Quality teams.
• Escalate unresolved deficiencies and risks.
• Identify and recommend process improvements ensuring GMP standards and BMS policies compliance.
• Support issue resolution across electronic systems.
• Minimum 7 years of experience in technical, quality, and/or regulatory role in biopharmaceutical industry.
• Minimum 1-2 years’ experience in a people management role.
• Bachelor’s degree in Pharmaceutical Sciences, Chemistry, or related discipline.
• Ability to travel abroad for training.
• 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.
• Apply knowledge of industry regulations (21 CFR Part 11, EU Annex 11, Data Integrity).
• Fluent in English for professional working proficiency.

Good to Have

• Experience with quality, regulatory, or supply chain systems (e.g., Veeva RIM, Veeva QMS, SAP).

Perks & Benefits

• Global platform and benefits for physical, mental, financial and social wellbeing.
• Global platform to reward your achievements.
• Generous time off to rest and recharge.
• Best-in-class health benefits.
• 8 People & Business Resource Groups.
• Wide variety of competitive benefits, services and programs.

Job description

Life at BMS

Working with Us

Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams.

Take your career farther than you thought possible.

Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us.

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.

Qualifications & Experience

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)

If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

Uniquely Interesting Work, Life-changing Careers

With a single vision as inspiring as “Transforming patients’ lives through science™ ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

On-site Protocol

BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:

Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.

Supporting People with Disabilities

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com.

Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

Candidate Rights

BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/

Data Protection

We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at https://careers.bms.com/fraud-protection.

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

If you believe that the job posting is missing information required by local law or incorrect in any way, please contact BMS at TAEnablement@bms.com. Please provide the Job Title and Requisition number so we can review. Communications related to your application should not be sent to this email and you will not receive a response. Inquiries related to the status of your application should be directed to Chat with Ripley.

R1596842 : Senior Manager, APMC Data Management