Data Integrity Manager-Quality Assurance

Data Integrity Manager-Quality Assurance
New Brunswick, NJ

Duration: 12+ months

The position is located in the Global Quality GxP IT Quality Assurance department within the Data Integrity tower. It is responsible for providing support to the Lead of the GxP Data Integrity program across the end-to-end product lifecycle, ensuring that regulatory and BMS requirements are thoroughly and effectively addressed promptly.

Top Skills on Resume :

• A university bachelor's degree in a Life Sciences area, with at least 5 years of experience in Data Integrity and GMP/CSV required.
• Cross-functional experience in three or more areas (i.e. IT, Computer System Validation, Research, Analytical/QC, QA, Engineering, manufacturing, Regulatory etc.) is desired
• Recent Data Integrity experience in a GxP environment.

Key Responsibilities and Major Duties
Provide oversight for the governance, management, and coordination of activities related to the Data Integrity Governance Program, including directing, developing, and maintaining Data Integrity compliance activities across the end-to-end product and all BMS sites and internal functions in alignment with relevant governmental regulations and guidelines.
Assist in conducting data integrity gap assessments, develop remediation plans and strategies, and manage tasks towards execution
Develop and utilize metrics and KPIs to assure programs success, and develop data analytics management processes
Utilize visualization technologies to create information from various data sets and sources
Ensure compliance with all Company policies and procedures, including safety rules and regulations
Support the various audit programs across and within departments around data integrity concepts and training

Key Competencies knowledge, skills, abilities, other
Cross-functional experience in three or more areas (i.e. IT, Computer System Validation, Research, Analytical/QC, QA, Engineering, manufacturing, Regulatory etc.) is desired
Recent Data Integrity experience in a GxP environment
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
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 a multicultural workforce.
Excellent team player attitude.