Senior Manager, Document Management

Bristol Myers Squibb

7 - 12 years

40 - 45 Lacs

hyderabad

Posted:1 day ago| Platform:

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Skills Required

data analysis erp sap quality systems clinical trials life sciences data privacy document management continuous improvement monitoring

Work Mode

Work from Office

Job Type

Full Time

Job Description

Provide strategy, oversight and tactical support of Document Management run the business activities. Including document authoring, coordination of review and comments resolution, approval, issuance, implementation, periodic review, and retirement.
Support health and performance of associated electronic management systems in compliance with
procedural guidelines.
Manage stakeholder needs in balance to priorities and execution of document procedural adherence.
Ensure up to date monitoring of review and approval ownership to prevent deviation of effectiveness for global document management and health authority requirement adherence.
Manage events associated to findings of compliance gaps and deviation from global processes.
Develop forecast, plan, and schedule that delivers timely flow of documents in and out of electronic system to include reporting and documenting completion as per governing procedures.
Liaison with the business as the subject-matter expert to ensure accurate document content and compliance with health authority regulations and expectations.
Provide leadership and coaching in relation to contemporary knowledge of current industry trends, standards, and methodologies as it relates to quality systems and management.
Manage risk and uncertainty, and to anticipate the need for and implement contingency plans.
Lead team to meet goals while resolving complex issues
Exercise sound judgment, using a risk-based approach, to ensure compliance with procedural document regulations, practices, and policies.
Develop, adjust, and monitor key performance indicators to identify and mitigate risk to business objectives.
Monitor trends to develop continuous improvement objectives and revised contingency plans (as required)
Collect metrics to identify trends and take appropriate action.
Communicate up to date status to impacted business units.

Qualifications & Experience

Bachelor of Science in Life Sciences (Chemistry, Biology) or Health Sciences.
Post-graduate qualification preferred.
A minimum of 7 years of pharmaceutical industry GMP experience and demonstrated leadership in Quality and/or Compliance discipline with in-depth knowledge of global health authorities regulations and requirements.
A minimum of 1-2 years experience in a people management role is required.
Prior employment on a pharmaceutical manufacturing site in a Quality or operations role is an advantage.
Fluent in English, with proven professional working proficiency in English for reading, writing and speaking.
Excellent communication with management, peers, and other functional areas.
Ability to apply critical thinking in a high-volume, fast-paced environment, in the knowledge that decisions taken support patient safety.
Strong people management expertise and ability to focus on execution of strategic decisions while balancing conflicting priorities.
Ability to effectively lead teams to thrive in a fast-paced, highly regulated environment.
Strong communication (written and verbal), leadership, influencing & negotiating and collaboration skills.
Demonstrated ability to influence areas not under direct control to achieve objectives and effectively communicate challenging goals & objectives.
Demonstrated ability to make and act on decisions while balancing speed, quality and risk.
Ability to work in a matrix environment and build strong relationships by being transparent, reliable and delivering on commitments.
A continuous improvement mindset.
Ability to build and maintain collaborative relationships with stakeholders in multiple geographic locations by engaging transparently, performing reliably, and delivering on commitments.
Customer and partner focus, including the ability to listen and incorporate feedback from key stakeholders.
Strong analytical skills and ability to deliver meaningful messaging from data analysis.
Strong working knowledge in software and applications relevant to the role (eQMS e. g. VEEVA Infinity, ERP e. g. SAP, artwork e. g. BAMS, regulatory e. g. Verity, MS Office Word, Excel, PowerPoint, SharePoint).

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