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.
Functional Area Description
The Worldwide Patient Safety (WWPS) group is responsible for ensuring the safety of our medicines. WWPS pharmacovigilance and pharmacoepidemiology deliverables include single case and aggregate safety monitoring, safety reporting, contributing to benefit-risk assessment, risk management planning and strategy, execution of certain postmarketing commitments, and ensuring compliance with global regulatory requirements.
Reporting to the Director, GRM Customer Engagement, the Associate Director - Quality & Compliance plays an important role as part of our Global Risk Management team in ensuring patient safety. This role is instrumental in the management of our external partners day-to-day contact center operations, ensuring all REMS interactions with Healthcare Professionals and Patients are managed in a high quality, compliant, and consistent manner.
Ensure patient safety through management of all aspects of REMS Customer Engagement operations while maintaining high quality performance and adherence to regulations, SOPs, and contractual requirements
Create, maintain, and ensure adherence to BMS REMS Contact Center SOPs, quality agreements, and work instructions pertaining to program management, quality assurance, data privacy, escalation handling, training, and business continuity.
Performs operations and quality reviews to ensure audit readiness, including all documentation, and ensure proper maintenance of the materials according to established procedures
Lead and manage Quality personnel (internal and external)
Manage complex quality and training activities including the development and implementation of quality plans and programs which meet business goal, objectives, and strategic priorities
Perform root cause analysis of issues identified during audits, closure of change controls, corrective actions/preventative actions/CAPAs and leading effectiveness checks
Maintain in-depth knowledge of all applicable BMS Corporate SOPs and directives
Manage interdepartmental Quality matters and provide Quality related guidance to other departments
Ensure the Key Performance Indicators (KPIs) of external partners and internal capabilities are monitored effectively and efficiently
Represent REMS Customer Engagement in cross-functional program teams focused on quality assurance
Effectively navigate across the matrix organization to manage the infrastructure and coordinate resources
Performs other duties and projects as assigned
Qualifications & Experience
Bachelor’s degree required with 10+ years of experience in Life Sciences, Pharmaceutical, or Healthcare industries, knowledge of Contact Center, and REMS requirements is preferred. Equivalent combination of advanced degree and less experience will be considered
Prior quality assurance and/or training experience required
Experience managing and developing a team, with a focus on diversity and inclusion
Effective communicator with excellent verbal and written skills both in comprehension and expression
Detail and process oriented with strong analytical and problem-solving skills
Exhibits all BMS Values (Integrity, Innovation, Urgency, Passion, Accountability, and Inclusion)
History of effectively multi-tasking against competing timelines and resources
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 firstname.lastname@example.org. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.
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