Associate Director, Document Management T500-16913 - Hyderabad - Bristol Myers Squibb

Bristol Myers Squibb Hyderabad

6 days ago

Description

Position: Associate Director, Document Management

Location: Hyderabad, India

Bristol Myers Squibb is inspired by a single vision – transforming patients' lives through science. Our diverse and promising pipeline in oncology, hematology, immunology, and cardiovascular disease drives meaningful change. We bring a human touch to every treatment we pioneer.

Position Summary

As an Associate Director of Document Management, you will provide strategic oversight and tactical support for document-related activities. This includes authoring, review coordination, approval, issuance, implementation, periodic review, and retirement of documents. You will ensure the performance of routine operations and strategic initiatives related to global and local documents, as well as APQRs, continuously improves to meet compliance needs and business priorities.

Key Responsibilities

Provide strategy, oversight, and tactical support for Document Management activities including document authoring, coordination of review and comments resolution, approval, issuance, implementation, periodic review, and retirement.
Ensure the performance of run-the-business and strategic initiatives associated with global and local documents, and APQRs, continuously improve to meet compliance needs and business priorities.
Support the 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 from effectiveness for global document management and health authority requirement adherence.
Manage events associated with findings of compliance gaps and deviations from global processes.
Develop forecast, plan, and schedule that delivers timely flow of documents in and out of electronic systems 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 anticipate the need for and implement contingency plans.
Lead the 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 risks 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.
Experience in a senior role with product quality complaints involving global teams and globally distributed products is required.
Fluent in English, with proven professional working proficiency in English for reading, writing, and speaking, including the ability to deliver clear and articulate presentations.
Commitment to Quality.

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.

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