Senior Specialist, APMC Data Management

Bristol Myers Squibb

3 - 8 years

7 - 11 Lacs

hyderabad

Posted:1 day ago| Platform:

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Skills Required

supply chain sap data management process improvement analytical pharma clinical trials issue resolution data entry data extraction

Work Mode

Work from Office

Job Type

Full Time

Job Description

Execute daily operations within regulatory systems such as Veeva Vault RIM, Quality Veeva Systems, and Regulatory Content Repositories, including extraction and review of submission registrations.
Execute daily configuration activities within S AP Batch Release Hub including but not limited to product release test configuration, customer release check management, and issue resolution.
Execute daily 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.
Execute daily operations within Authorized Supply Chain Maps including but not limited to document extraction configuration, exception/issue handling and data entry.
Execute daily operations within Document Data Extraction including but not limited to document extraction configuration, exception handling and data entry.
Assess data from eCTD and CTD Module 3 documents to ensure accuracy, completeness, and consistency with relevant information from Quality and Supply Chain functions.
Collaborate closely with CMC, Supply Chain, and Quality teams to align priorities, resolve issues, and provide status updates.
Escalate unresolved deficiencies to the appropriate stakeholders.
Escalate risks proactively to support the timely release of products.
Identify and recommend opportunities for process improvement.
Ensure compliance with GMP standards and BMS policies and procedures.
Provide support for issue resolution across additional electronic systems, which may include (but are not limited to):
- Change Controls
- Deviations
- Change Control Restrictions Management
- SAP Batch Release Hub
- Authorized Supply Change Maps
- Document Data Extraction

Qualifications Experience

Demonstrated understanding of Biologics, Pharmaceutical, and/or Cell Therapy operations and processes required.
Understand product release activities for drug substance, drug product and finished product for US, EU and rest of world.
Understand product lifecycle submissions for marketed products, including global post-approval changes, renewals, and regulatory updates within regulatory systems.
Operates under routine supervision from a direct manager.
Minimum 3 years of experience in a technical, quality, and/or regulatory role within the biopharmaceutical industry with demonstrated acumen in Quality Compliance or Operations preferred.
Strong ability to assess data accuracy and consistency between manufacturing and regulatory information leveraging SAP, eCTD, and CTD Module 3 submissions.
Solid working knowledge of Bills of Materials as they relate to the pharmaceutical supply chain.
Prior experience with electronic quality management, regulatory management, or supply chain systems, including Veeva RIM, Veeva QMS, and SAP, preferred.
Proven ability to build strong relationships through transparency, reliability, and consistent delivery on commitments.
Capable of providing innovative ideas and making decisions that balance speed, quality, and risk.
Basic knowledge of industry regulations, including 2 1 CFR Part 11, EU Annex 11, and Data Integrity principles.
Demonstrates initiative, ownership, and accountability for assigned tasks.
Collaborative mindset with the ability to work effectively within cross-functional teams.
Strong communication and organizational skills, with an analytical approach to problem solving.
Fluent in English, with proven professional working proficiency in reading, writing, and speaking, with the ability to contribute to clear documentation and presentations.

Education

Bachelor s degree in Pharmaceutical Sciences, Chemistry, or a related discipline.

Travel

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

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