Head of Global Quality GxP Data Integrity

The position is in the Regulatory Compliance and External Engagement (RCEE) Quality department and is responsible for developing the strategic vision for the Data Integrity program, including the creation, implementation and oversight of an effective GxP Data Integrity program across the end-to-end (GPS and R&D) product lifecycle to ensure that BMS has a robust quality system related to data integrity that ensures compliance with regulatory and BMS requirements. The data integrity program will proactively prevent data integrity issues before they occur. In the unlikely event that one occurs, the data integrity system will detect it, investigate it, drive to root cause identification and ensure the implementation of corrective and preventative actions to prevent recurrence, using ICH Q9 principles and assure regulatory compliance. Through the use of key performance indicators, the program will trend and seek continuous improvement opportunities.

Key Responsibilities and Major Duties

General Activities

• Provide strategic leadership for the establishment of a robust data integrity program building on work completed.
• Provide oversight for the governance, management and coordination of activities related to the Data Integrity Program including, without limitation, directing, developing, and maintaining Data Integrity compliance activities across the end-to-end product lifecycle (GPS and R&D) and across all BMS sites and internal functions in alignment with relevant governmental regulations and guidelines.
• Define and implement a data integrity governance program.
• Provide active support during regulatory agency and third party inspections
• Develop and utilize metrics and KPIs to assure programs' success and continuously improve
• Ensure compliance with all regulatory requirements relating to data integrity, Company policies and procedures, including safety rules and regulations
• Support the various audit programs across and within departments around data integrity concepts and training
• Adherence to BMS core behaviors

Meeting Participation

• Attend governance councils and forums as needed to communicate DI risks and KPIs
• Oversee the execution of the GQ GxP Data Integrity Community of Practice meetings
• Attend RCEE departmental meetings
• Interface meetings with functional areas supported
• Departmental meetings

Degree/Certification/Licensure
University graduate (science degree preferred)
• University Graduate; Life-Sciences or computer science degree preferred.

Experience - Responsibility and minimum number of years

• A minimum of 10 years' experience and in-depth knowledge of Data Integrity requirements
• 3-5 years' experience and in-depth knowledge of GxP computer validation, and Part 11 requirements
• 5-10 years' experience in the GxPs
• 1-3 years of Management of people

Key Competencies - knowledge, skills, abilities, other

• Demonstrated Leadership and management capabilities in order to manage one Data Integrity Lead
• Cross-functional experience in three or more areas (i.e. Research, Analytical/QC, QA, Engineering, manufacturing, Regulatory etc.) is desired
• Experience in Pharmaceutical or BioTech manufacturing desired
• Ability to collaborate and lead cross-functionally to help drive continuous improvement and promote knowledge sharing and endorsement of best practices across sites
• Provide subject matter expertise in regulatory requirements, expectations, specifications/methods/compendia, manufacturing technology, and/or quality assurance is required.
• Ability to build alignment with business partners including research & development, commercial operations and manufacturing regional and site leaders
• Ability to demonstrate strategic thinking capability with strong project management focus as well as focus on execution of strategic decisions while balance conflicting priorities
• Demonstrate the ability to influence areas not under direct control to achieve objectives and effectively communicate challenging goals & objectives.
• Demonstrate 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.
• Good understanding of the drug and device development process from discovery through to regulatory filing and approval of drug applications as well as commercial manufacturing processes.
• Must understand industry accepted software development and validation life cycle programs.
• Excellent interpersonal skills, including written and verbal communication.
• Strong sense of ethics, diplomacy and discretion.
• Commitment to Quality.
• Strong critical thinking to analyze complex situations and discern critical issues.
• Able to work effectively with multicultural workforce.
• Excellent team player attitude.