Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases.
One shared journey is moving us forward at Bristol-Myers Squibb. Around the world, we are passionate about making an impact on the lives of patients with serious disease. Empowered to apply our individual talents and ideas so that we can learn and grow together. And driven to make a difference, from innovative research to hands-on community support. 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 the resources to pursue their goals, both at work and in their personal lives.
This role will focusing on the Data Integrity Governance program and is accountable to establish and maintain an enterprise-wide Data Integrity Governance system to ensure that regulatory and BMS requirements are addressed thoroughly and effectively in a timely manner. Also, accountable for supporting other Quality Programs as assigned.
- Governing, managing and coordinating activities related to Data Integrity Governance Program. Duties include directing, developing, and maintaining Data Integrity compliance activities across GMS sites and Internal functions. Responsible for developing policies and procedures and coordinating all relent activities between Quality, IT and other departments in relation to implementation, maintenance and change management of assigned programs.
- The AD will develop and utilize metrics and KPIs to assure programs’ success.
- Provide oversight and direct support during inspections
- Ensure compliance with all Company policies and procedures, including safety rules and regulations.
- Create and maintain a high level of commitment to quality and compliance. Understand the global regulatory environment and work proactively to assure that the state of the compliance is maintained.
- Support other Quality Programs and electronic systems compliance tasks as assigned
- Communicate effectively, and build cooperative and supportive working relationships with all sites and cross-functionally (GMS, R&D, MS&T, etc) across BMS. Interface and influence executive members.
- Benchmark within and outside of the Company, including regulatory agencies, business partners and suppliers.
- Demonstrate ability to lead and motivate employees in all operational areas of the Company.
- Lead and engage to achieve professional growth and attain established goals across GMS.
- Ensure operational excellence and continuous improvements
- Support the Global Audit Program
- Perform related duties as assigned.
- A minimum of 12 years of extensive experience and demonstrated leadership in Quality and/or Compliance discipline with in-depth knowledge of Quality and Compliance systems, operations and strategy.
- A minimum of 3 years experience and in-depth knowledge of Data Integrity requirements
- A minimum of 5 years experience and in-depth knowledge of GMP computer validation, and Part 11 requirements
- Cross-functional experience in three or more areas (i.e. Research, Analytical/QC, QA, Engineering, manufacturing, Regulatory etc.) is desired
- Experience with senior level interactions and influence with Manufacturing Operations, Regulatory, R&D, Medical and Commercial functions
- Experience in Pharmaceutical or BioTech manufacturing desired
- Experienced in management of people and challenging self and others to continuously learn and improve.
- Collaborate and lead cross-functionally to help drive continuous improvement and promote knowledge sharing and endorsement of best practices across sites
- Strong verbal and written communication skills.
- Excellent influencing, facilitation and project management skills.
- Subject matter expertise in regulatory requirements, expectations, specifications/methods/compendia, manufacturing technology, and/or quality assurance is required.
- Capability to build alignment with business partners including research & development, commercial operations and manufacturing regional and site leaders
- Demonstrated strategic thinking capability with strong project management focus and ability to focus on execution of strategic decisions while balance conflicting priorities
- Demonstrated ability to influence areas not under direct control to achieve objectives and effectively communicate challenging goals & objectives.
- Demonstrated strong leadership capability with 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.
- Ability to provide innovative ideas to improve quality and compliance that create value including seeking new information and external insights.
At least 12 year(s)
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