Vice President, GBU Quality

Bristol Myers Squibb • Devens, MA

3d • Hybrid

About The Position

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. Recognizes the current context of where we are (run the business) and future actions, and ensure the organization can operate in a compliant and effective way to maintain continuity of supply.

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.

Responsibilities

• Supports the development, direction, and execution of the quality strategy for the GBU (Biologics & Pharma) manufacturing organization.
• Provides leadership direction for a multi-functional group of quality professionals, aligned with company culture that recognizes market practices and regulatory trends to achieve a uniform quality strategy, as well as other senior quality leaders responsible to enable quality activities critical to compliance and network related projects.
• Ensures that a robust and effective quality management system is implemented according to the global standards, to achieve the quality objectives of the GBU (Biologics & Pharma) Manufacturing operations.
• Progresses on the suitability and effectiveness of the quality management system and GMP compliance through participation in the required quality management reviews.
• Deploys Quality Risk Management Techniques for quality oversight and problem resolution to mitigate risk in conjunction with BMS Manufacturing/Supply management and Quality.
• Manages/supports the resolution of quality and technical problems within the GBU organization in alignment with global standards, including Internal and external manufacturing.
• Supports audits and Health Authority inspections for the GBU sites as necessary, including the assistance in the generation of HA responses and CAPAs.
• Ensure that the all-critical and major issues, which may have an adverse effect on the quality of the product or represent a risk of supply are escalated as per standard procedures to management and are resolved within stated timelines.
• Assures appropriate quality governance through performance of management reviews of quality KPI’s, metrics, process performance indicators and quality system signals and supply risks. Initiate corrective actions when necessary and perform follow-up on resulting measures.
• Ensures that GMP follow up actions for audit/inspection observations are tracked and actioned as per current QMS (Quality Management System).
• Provides quality oversight and adequate resourcing where applicable within the GBU organization for complex projects (transfers, launches, due-diligence, other) – providing support where needed to ensure compliance with the QMS, and to facilitate issues escalation and resolution.
• Coordinates and/or provides SME (Subject Matter Expert) input to for BMS policies, directives, and SOPs related to quality compliance when required.
• Leads communication and develops effective strategies & partnership with stakeholders from Manufacturing, SB&E, Supply Chain, Regulatory, Project Management, and Operations.
• Builds strong organizational capability for current and future needs. Recruit and develop global talent to sustain local and global competitiveness. This includes identifying individuals with leadership potential, providing mentoring and enrichment opportunities consistent with succession planning.
• Develop a high-performance culture within the GBU Quality organization. Coaches, leads and mentors direct reports and builds a highly capable team through the attraction, training and development of the necessary skilled professionals to meet business needs.
• Supports deployment of operational excellence strategies within Quality GBU Manufacturing
• Prepares and manages Quality GBU organizational budget.
• Champions the development & implementation of innovative and digital solutions across the GBU Quality team and organization.

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) Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non-Exempt, Hourly Employees: 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Executive
• Number of Employees: 5,001-10,000 employees