Bristol Myers Squibb Manager, GxP ITQA Data Integrity in New Brunswick, New Jersey
MANAGER GxP IT QUALITY ASSURANCE (GxP ITQA Data Integrity)
Global Quality Functional Area Description
Global Quality GxP Information Technology Quality Assurance (GQ GxP-ITQA) ensures all GXP computerized systems across the end-to-end product lifecycle meet BMS standards and global regulatory authority requirements and expectations.
Principal Objective of the Position
The position is in the Global Quality GxP IT Quality Assurance department within the Data Integrity Governance tower and is responsible for providing oversight of an effective and knowledgeable GxP Data Integrity Governance program across the end-to-end (GPS and R&D) product lifecycle to ensure that regulatory and BMS requirements are addressed thoroughly and effectively in a timely manner.
Key Responsibilities and Major Duties
• Provide oversight for the governance, management and coordination of activities related to the Data Integrity Governance Program include 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.
• Provide active support during regulatory agency and third party inspections
• Develop and utilize metrics and KPIs to assure programs’ success
• Ensure compliance with all Company policies and procedures, including safety rules and regulations
• Support the various audit program across and within departments around data integrity concepts and training
• Adherence to BMS core behaviors
• Attend GQ GxP-ITQA Data Integrity Community of Practice meetings
• Attend GQ GxP-ITQA departmental meetings
• Interface meetings with functional areas supported
• Departmental meetings
• Head of the GQ GxP ITQA organization
• Lead of the GQ GxP ITQA Data Integrity Governance
• Other members of GQ GxP-ITQA and department management.
• Management and staff from the GPS and R&D departments involved in GxP regulated operations
• IT Quality Management Services
o Validation Services
o Contracted Enterprise Service partners.
• Management and staff directly responsible for the business operations of computerized systems
• Information Technology staff at commensurate levels of the organizations
• Management of the associated quality departments
• Inspectors during the conduct of health authority inspections
SUMMARY OF QUALIFICATIONS
• University Graduate; BA/BS Life-Sciences degree preferred.
Experience – Responsibility and minimum number of years
• A minimum of 2 years’ experience and in-depth knowledge of Data Integrity requirements
• 3-5 years’ experience and in-depth knowledge of GMP computer validation, and Part 11 requirements
Key Competencies – knowledge, skills, abilities, other
• 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.
• Ability to manage competing priorities
Travel Required (nature and frequency) About 5-15% travel to meet with stakeholders, attend professional meetings and seminars
Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled