Associate Director, Quality Product Lead – Global Quality

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.

REQUIRED KNOWLEDGE AND EDUCATION:

• Minimum of a Bachelor’s degree in a Natural Science, Pharmacy, Engineering, or other Healthcare-related field. Advanced degree preferred.

• Must have 8-10 years Quality experience in the Biopharma industry.

• Demonstrated influential Quality leadership expertise and experience working in a matrix organization with and/or supporting Technical, Supply Chain and Regulatory functional areas.

• Must be skilled in strategic thinking, managing through systems, innovation management, and negotiation. Must possess a strategic perspective, leading vision and values, global acumen, and leadership disposition.

• Must be able to critically interpret problems and effectively communicate in an impactful manner to management, and the broader organization with clarity and a high level of brevity and accuracy.

• Capability to build alignment amidst diverse perspectives with business partners including research and development, and manufacturing at global and site levels.

• Experience in biologics and/or pharma quality.

• Demonstrated strategic thinking capability with strong project management skills with the ability to focus on execution of strategic decisions while balancing multiple priorities.

• Demonstrated ability to influence other functional areas achieve shared objectives and effectively communicate objective status.

• Self-starter who views challenges as opportunities to improve.

• Demonstrated leadership capability with ability to align on, make and act on decisions while balancing speed, quality and risk.

• Ability to provide innovative ideas or alternatives that create value including seeking new information and external insights without compromising compliance.

• Excellent communication and interpersonal skills, with the ability to interface with a broad range of internal and external stakeholders at all levels of the organization.

• Strategic thinker who sees the bigger picture and understands how the parts impact the whole (end-to-end brands) and makes the best decisions for the business.

• Experience of making quality focused decisions and provides clear feedback for potential options.

• Experience in influencing, communicating and negotiating experience and capabilities in a matrix environment.

• Adapts to changing work environments, work priorities and organizational needs.

• Strong project management and execution skills and can manage multiple projects and prioritize as needed. Ability to plan and conduct projects within a multi-disciplinary environment.

DUTIES AND RESPONSIBILITIES

• Is the single Quality focal point for the BMS Commercial Brands and is responsible to engage with the Quality Internal Site Quality Heads/EXM leads for achieving brand deliverables that are aligned with the brand strategy. Responsible for including Quality projects in the development and execution of the Commercial Brands Book of Work (BOW) and ensure support from the Quality operations team (s) to meet timelines.

• Responsible for identification of operational and strategic risks and associated mitigation plans.

• Core member of the GO-Team, Technical Product Team and the Regulatory and supply team (RST TPT, and/or TPT sub-teams) for Key Brands.

• Is responsible to work in partnership with Go/TPT team members to develop and deliver on the strategic path for commercial brands by approving changes, reviewing initial applications and post approval supplements and rapidly responding to Health Authority (HA) queries.

• Has a shared responsibility for the PAI readiness of a site as they relate to a specific product.

• Responsible to work closely with the supply chain lead to escalate any potential product shortage notifications and mitigations.

• Evaluates impact of proposed process changes on the end-to-end supply chain and develops, executes, and oversees change implementation strategies as the quality approver of global post marketing changes.

• Establishes the responsibilities for reviewing and/or coordinating Quality operation reviews of regulatory submissions and responses to HA inquiries.

• This includes leveraging existing RACIs.

• Responsible for on time delivery of the E2E APQR for represented key brands and aligning on any conclusions and or actions.

• Responsible to support end to end view into product quality complaints and trends across the brand and Business Units.

• Author Quality chapter for yearly brand strategy document.

• Responsible to facilitate Drug shortage notifications to management and lead the process for endorsement and approval.

• Assigned as the Lead investigators for complex global investigations. Responsible for ensuring that any HA notifications that are required and approved within notification timelines.
  

BMSBL

#LI-Hybrid

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.

BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

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