In support of the Chief Quality Officer, define and shape the Quality strategy for the Global Business Unit (GBU) Manufacturing Quality Network which includes the biologics & pharma operating units, internally and externally, to ensure a high level of cGMP compliance and the safety, efficacy, and quality of all bio and pharma manufactured commercial products.
Responsible for direction of the quality operations teams supporting manufacturing, laboratory operations, and releasing or certifying of all BMS’ products produced, including internal and external manufacturing.
This role will ensure consistency and alignment in the overall GBU Network Strategy and operational performance.
The role will be part of the Global Quality Leadership Team (GQLT), the GBU Leadership Team, and will manage a team of managers, including the Site Quality Heads of internal manufacturing sites, and other Quality Leaders responsible for enabling quality activities critical to compliance and network related projects.
This role will require strong collaboration with the Global Manufacturing and Supply Chain functions.
Drive significant impact of current and future business performance and network strategies, through building a functionally excellent infrastructure (knowledge, processes, and systems) to handle moderate to high complexity quality and compliance responsibilities to ensure quality.
Requirements
B.S. degree in relevant Science or Engineering.
Advanced degree preferred (MBA, MS or PhD)
20+ years of experience managing quality and compliance organizations
Proficiency in quality compliance processes and regulations, e.g., cGMP/GDP regulations for External Manufacturing QA.
A thorough understanding of company policies and regulatory requirements, and their relation to the management and documentation of product quality investigations.
Thorough understanding of technical areas related to pharmaceutical and/or biological manufacturing, chemical and/or biochemical analyses, microbiological analyses, statistical methods, regulatory and quality control/quality assurance processes.
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.
Has a proven record of accomplishment of delivering results, is action oriented, and has worked directly with compliance remediation activities as a result of regulatory actions.
Strategic thinker who sees the bigger picture and possesses high business acumen; understands how the parts impact the overall business (end to end enterprise) and makes the best decisions for the Organization.
Excellent influencing and negotiating experience and capabilities in a matrix environment.
Must be able to interact with senior leaders in this capacity and as such is seen as a highly regarded and a credible leader with the ability to act on behalf of GQ (Internal Sites) and interface with stakeholders in a matrix environment.
Uses judgment to make sound decisions based on information gathered and analyzed.
Ability to build strong, trusting relationships, lead large/complex programs, and work across divisions, diverse business backgrounds and cultures.
Sets and maintains high performance standards.
Pays close attention to detail, accuracy, and completeness.
Adapts to changing work environments, work priorities and organizational needs.
Plans and organizes tasks and work responsibilities to achieve objectives.
Sets priorities.
Schedules activities.
Enterprise advocate: appropriately evaluates tradeoffs to make bold decisions that are in the best interest of BMS and of our patients; understanding the bigger picture beyond own functional area, seeks to have an impact on organization wide performance; embrace complexity but strive for simplicity
External mastery: constantly looks outside the organization to understand customer needs, competitors and global trends and uses the data to achieve a competitive advantage for BMS
Change Activator: Relentlessly identifies and creates game-changing opportunities that lead to higher organization performance and influences others to do the same
Courageous Innovator: stretches beyond the expected to succeed in a rapidly evolving, strategic and transformational environment
Authentic Leadership: Demonstrates an honest and unbiased understanding of their own strengths, limitations, and values; lives up to their principles and conviction without being rigid or dogmatic; generates trust by maintaining the highest level of consistency between their words and their actions.
Talent Developer: proactively develops talent for the long and short-term, both within and outside their team.
Benefits
Health Coverage: Medical, pharmacy, dental, and vision care.
Wellbeing Support: Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).
Financial Well-being and Protection: 401(k) plan, short
and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support.
Work-life benefits include: Paid Time Off US Exempt Employees: flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees)
Based on eligibility*, additional time off for employees may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs and an annual Global Shutdown between Christmas and New Years Day.
All global employees full and part-time who are actively employed at and paid directly by BMS at the end of the calendar year are eligible to take advantage of the Global Shutdown.