Senior Counsel, Quality Law
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.
The Senior Counsel, Quality Law role will have the opportunity to join the dynamic GPS Law team at BMS. The GPS Law team provides critical support and partnership to the Company’s Global Product Supply & Development organization, helping to deliver on our mission to serve patients in need. The GPS Law team provides comprehensive legal support for the Company’s manufacturing operations, supply chain, import/export, customs and trade, facilities and engineering, product development, EHS and Occupational Health matters, and Quality.
The Global Quality Law team, which is a part of the GPS Law Team, has responsibility to provide legal support for the Company’s GxP/Global Quality matters for all therapeutic areas including Cell Therapy. Example counselling relates to manufacturing (GMP), inspections, compliance and regulatory matters, and counterfeiting and market actions (e.g., recalls, shortages). The Quality Law team also provides legal support for due diligence matters related to business development and mergers and acquisitions.
Primary responsibilities for Senior Counsel, Quality Law:
Proactively advise and counsel clients in Quality organization to resolve issues relating to GxP matters including GMP, GCP, GDP and GLP.
Responsible for providing legal advice on Quality matters and support for Quality-related compliance investigations.
Identify and manage legal risk, particularly GxP regulations.
Provide strategic legal advice across a diverse range of product categories, including pharmaceuticals, cell therapy, biologics and medical devices.
Guide and help shape FDA and state inspection preparedness and support for communications with regulatory agencies.
Help manage regulatory inspections and interactions with health authorities.
Collaborate across business colleagues and Law Department matrix to ensure delivery of seamless, comprehensive legal advice.
Anticipate and proactively identify legal issues applying an enterprise view, and provide clear, operational and effective legal advice that supports informed decisions.
Deliver effective presentations to Law Department/ Business Units.
Lead and organize functional or substantive working groups assessing significant legal issues.
Bachelor’s or equivalent degree; JD required.
Qualification, or ability to become qualified to practice in-house in New Jersey.
Knowledge of, and experience with, pharmaceutical industry and laws.
Experience with GxP, particularly GMP, strongly preferred.
Minimum of 8 years of legal experience (law firm, in-house, or government experience required).
Former FDA or other Health Authority experience preferred.
Ability to navigate complex legal issues while exhibiting sound judgment and objectivity; systematic approach to decision making; strong attention to detail; solid analytical/problem solving skills; ability to determine root cause and identify viable and alternate solutions.
Ability to discuss various topics with senior executive leadership is essential for success in this position.
The ideal candidate must have excellent verbal and written communication and collaboration skills, be proactive, and be able to prioritize and manage multiple projects and clients.
The candidate will operate as part of the Law Department focused on providing excellent, pragmatic, solutions-oriented services to clients.
Superior personal integrity and ethics are required.
Must be highly collaborative with the ability to garner the trust of others, build productive internal and external professional relationships, and operate effectively in a multi-cultural environment.
Commitment to a diverse and inclusive workplace is critical.
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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