Senior Manager, Data Integrity SME

02 Dec 2024

Vacancy expired!

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:

Reporting to Associate Director, the Senior Manager for DI Governance will manage the development, implementation and sustainability of quality and technical training solutions for Data Integrity Program. This position will ensure employees and contract staff meet compliance requirements relating to knowledge, skill and practices necessary for her/his job performance and that they remain prepared to perform assigned tasks.

Key Responsibilities and Major Duties:

  • Provide DI guidance and ensure the Systems/ process, implementation and change management of used across GxP operations are conducted in compliance with applicable global regulatory requirements and industry data integrity standards

    Create/Maintain the Data Integrity policies and procedures.

  • Collaborate with other leaders across the organization and assist in the continuous improvement and lifecycle management of GMP policies and quality management system, including providing guidance and direction for transitioning from clinical to commercial phase GMP operations

  • Provide expertise and guidance in interpreting global governmental regulations, agency guidelines and internal procedures to assure continued compliance across all computerized systems

  • Manage projects and training initiatives which directly support Network and GxP DI initiatives, to effectively implement strategic business objectives in driving quality, compliance and safety. ·

  • Provide adjunct oversight of regulatory compliance across the end-to-end product lifecycle (GPS and R&D) for software development and validation lifecycle activities associated with regulated computerized systems to ensure conformance to cGxPs, guidance documents, applicable industry accepted standards and BMS requirements.

  • Provide active support during regulatory agency and third party inspections

General Activities:

  • Ensure compliance with all Company policies and procedures, including safety rules and regulations

  • 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

(Disclaimer: The responsibilities listed above are only a summary and other responsibilities will be requirements as assigned)

Key Stakeholders/Contacts :

  • Head of the GQ GxP ITQA organization

  • Lead of the GQ GxP ITQA Quality and eCompliance

  • Direct (as needed) or contracted reports

  • 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

    • Validation Services

    • Service and Provider Quality Management

    • 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

Degree Requirements:

  • B.S in science, engineering, biochemistry or related discipline, or its equivalent is highly desired, life Sciences preferred

Experience Requirements:

  • A minimum of 3 years’ experience and in-depth knowledge of Data Integrity requirements, worked at a site or function as a Data Integrity Representative

  • A minimum of 6 years’ experience and in-depth knowledge of GMP computer validation, and Part 11 requirements

  • Proven experience in the interpretation and understanding of GxPs for the controlled management of electronic records and signatures (minimum 4 years’ experience).

Key Competency Requirements:

  • Bio-tech/pharmaceutical/GMP industry or experience in a highly regulated environment strongly preferred ·

  • Extensive knowledge of SOPs and GxPs and the know-how to work and manage within a regulated environment ·

  • Strong change management skills and demonstrated ability to simplify and improve business processes ·

  • Excellent leadership skills with the ability to motivate and manage a team with matrix reporting relationships ·

  • Adaptable to a fast paced, complex and ever-changing business environment ·

  • Effective verbal and written communications skills ·

  • Excellent verbal communication, documentation and technical writing skills ·

  • Demonstrated creative problem-solving skills under resource constraints and time pressure

  • Ability to demonstrate strong project management focus as well as focus on execution of strategic decisions while balance conflicting priorities

  • Must understand industry accepted software development and validation life cycle programs.

  • 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.

Travel Required:

Up to 20%

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.

Physical presence at the BMS worksite or physical presence in the field is an essential job function of this role which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and enhances the Company culture.

To protect the safety of our workforce, customers, patients and communities, the policy of the Company requires all employees and workers in the U.S. and Puerto Rico to be fully vaccinated against COVID-19, unless they have received an exception based on an approved request for a medical or religious reasonable accommodation. Therefore, all BMS applicants seeking a role located in the U.S. and Puerto Rico must confirm that they have already received or are willing to receive the full COVID-19 vaccination by their start date as a qualification of the role and condition of employment. This requirement is subject to state and local law restrictions and may not be applicable to employees working in certain jurisdictions such as Montana. This requirement is also subject to discussions with collective bargaining representatives in the U.S.

Our company is committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an approval of accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application or if you are applying to a role based in the U.S. or Puerto Rico and you believe that you are unable to receive a COVID-19 vaccine due to a medical condition or sincerely held religious belief, during or any part of the recruitment process, please direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

Full-time