Director

Description:

Reporting to the Executive Director, IT Quality & Data Integrity, this role will define and implement the Data Integrity program for all GxP data, whether it is manual or electronic, including ensuring that all GXP computerized systems across the end-to-end product lifecycle meet data integrity principles.  The Data Integrity Program will implement a quality system that assures regulatory compliance, product quality and patient safety related to data integrity that, in the first instance, ensures data integrity and detects, investigates and corrects.

The position is in the IT/ QA Quality department. It is responsible for providing oversight of an effective and knowledgeable 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, in the event that one occurs, the data integrity systems will detects it, investigates it, drives to root cause identification and ensure the implementation of corrective and preventative actions to prevent recurrence and assure regulatory compliance.  Through the use of key performance indicators, the program will trend and drive continuous improvement opportunities. 

Responsibilities

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 in partnership with the S&BE organization in GQ / and ensure alignment with the metrics set by the S&BE organization in GQ.
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.
Oversee the execution of the GQ GxP Data Integrity Community of Practice meetings. 
Adherence to BMS core behaviors.

Requirements

Bachelor’s degree in life sciences; computer sciences, or related field.
A minimum of 10 years of experience in the biopharma/pharmaceutical industry, with in-depth knowledge of Data Integrity requirements; 3-5 years’ experience and in-depth knowledge of GxP computer validation and Part 11 requirements, and 5-years’ experience in the GxPs
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.
Ability to manage competing priorities.