Associate Director, GxP IT Quality Assurance & E-Compliance

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.

Experience Requirements

• Proven experience in the interpretation and understanding of GxPs for the controlled management of electronic records and signatures (minimum 6-8 years’ experience).

• Demonstrated management of direct report and matrix staff

• University Graduate: Life-Sciences or information systems degree preferred.

Key Competency Requirements:

Experience with Veeva QMS quality management systems or similar
preferred

• Experience in the Biotech/Pharmaceutical Industry or similar,

regulated industry required

• Excellent analytical, interpersonal and communication skills, including

written and verbal communication

• Previous experience as a quality manager for a life sciences company

regulated by the FDA preferred

• In-depth understanding of industry accepted software development

and validation life cycle programs and related IT controls

• Previous experience in risk-based approach to computerized system

validation a plus. Understanding of quality risk-management concepts

(ICH Q9) preferred

• 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

• Strong sense of ethics, diplomacy, and discretion

• Commitment to Quality

• Strong critical thinking to analyze complex situations and discern

critical issues

• Ability to manage various projects, create and work within internal

timeliness, solve problems, deliver on commitments and utilize

interpersonal skills in a cross-functional team

• Able to work effectively with multicultural workforce

• Excellent team player attitude

• Ability to manage competing priorities

Responsibilities:

· Provide management 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.

· Recruit and train staff to carry out all functions of the GQ GxP-ITQA Quality and eCompliance tower. Routinely review the performance of direct reports regarding the achievement of goals, objectives and BMS Core Behaviors

·Author, review and/or approve appropriate BMS policies, directives, and procedures in alignment with relevant governmental regulations and guidelines.

About 15% travel to meet with stakeholders, attend professional meetings and seminars

BMSBL

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.