Bristol Myers Squibb Company

Compliance & Auditing Data Integrity Manager

Location
Manati, PR, United States
Posted
Aug 27, 2020
Ref
R1527143
Required Education
Bachelors Degree
Position Type
Full time
At Bristol Myers Squibb, we are inspired by a single vision - transforming patients' lives through science.In oncology, hematology, immunology and cardiovascular disease - and one of the most diverse and promising pipelines in the industry - each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.

Summary:

This role will support the Data Integrity (DI) program for the Site Quality Compliance Team at the Manati site. This role will develop and improve the data integrity program on site. Additionally, this role will perform compliance reviews of electronic data, contribute to data risk assessments, and help drive a strong data integrity culture on site. This role will focus on providing GxP subject matter expertise to ensure data integrity compliance and support of the Data Integrity program through remediation activities and is accountable to maintain a site-wide Data Integrity Governance system to ensure that regulatory and BMS requirements are addressed thoroughly and effectively in a timely manner. Communicate data integrity training/communication regarding data integrity principles to the site as needed.

Key Responsibilities and Major Duties

Provide day to day support for the governance, management, and coordination of activities related to the Data Integrity Governance Program include implementing and maintaining Data Integrity compliance activities in alignment with relevant governmental regulations and guidelines. Responsible for implementing BMS policies and procedures Support and manage remediation efforts, utilizing QRM based principles to identify risk and establish appropriate prioritization. Provide active support during regulatory agency and third party inspections

General Activities
  • Develop and utilize metrics and KPIs to assure programs' success and data integrity remediation progress
  • Assist in conducting data integrity gap assessments, develop remediation plans and strategies, and manage tasks to completion.
  • Ensure compliance with all Company policies and procedures, including safety rules and regulations
  • Support the development of standardized tools and training
  • Benchmark within and outside of the Company, including regulatory agencies, business partners and suppliers
  • Support the various audit program across and within departments around data integrity concepts and training
  • Adherence to BMS core behaviors


This is intended to be a general job description and should not be construed as all-inclusive

Knowledge/Skill:
  • Bachelor's Degree in Science degree (Biology, Chemistry, Chemical Engineering, and related)
  • A minimum of 3 years experience and in-depth knowledge of Data Integrity requirements
  • A minimum of 3 years experience and in-depth knowledge of GMP computer validation, and Part 11 requirements
  • Strong knowledge of relevant GMP, FDA, EU regulations and the ability to interpret and apply them for intended use
  • Fully bilingual (Spanish/English) communication skills, both written and verbal.
  • Self-motivated, creative and team work oriented
  • Strong knowledge in validation activities
  • Technical and scientific capability to establish quality philosophy Excellent interpersonal skills and the ability to interact with people at all levels
  • Effective communication Skills
  • Sense of urgency and analytical thinking
  • Proficient knowledge of computer systems (Microsoft Office etc.) and applications like Trackwise and SAP
  • Willing to work irregular hours, any work shift and any day of the week as needed.


Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

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 with the resources to pursue their goals, both at work and in their personal lives.