Senior Director Network Quality and Compliance Excellence (R1557217-en-us)
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.
Bristol-Myers Squibb is searching for a remarkable Senior Director, GMQ Quality & Compliance Excellence to join our growing team. As our Senior Director, GMQ Quality & Compliance Excellence, you will support the Executive Director, GMQ Network Compliance Excellence & Strategy and have interconnectivity to the three GMQ Quality Business Units (Internal Bio/Sterile, Internal Pharma and External Manufacturing), Analytical Sciences & Technology, and the associated GMQ sites ensuring excellence in Quality & Compliance performance and network interconnectivity across the enterprise.
In this role, you will have accountability for centralizing QMS implementation associated with Quality System (QS) optimization and/or continuous improvement/OPEX efforts; driving QS execution consistency; ensuring Compliance Excellence and Health Authority inspection readiness; driving the Tier 2 GMP Quality Council and its linkage to Tier 1 and Tier 3 GMP Quality Councils across the GMQ network. The Quality Council interdependence requires proactive, GMP execution performance monitoring across the enterprise to identify trends, risks and risk mitigations. The incumbent will lead the network Supplier Quality efforts, partnering with Global Procurement, and provide expertise and ownership of targeted Quality Systems and electronic solutions.
In addition, the incumbent will ensure there is solid interconnectivity across GMQ, GQ (GQS, RCEE), and GPS sister organizations (Operations, MS&T, Global Procurement, IT). The guiding principle of this role is to ensure a high level of cGMP compliance of our global quality systems, and production of high quality, manufactured commercial drug products for BMS. The incumbent will lead a team of Managers located in the US, Ireland and Switzerland, with diverse responsibilities required to drive global solutions and enable processes that increase efficiency, compliance and product and process control aligned with the long-term strategy of the organization.
Ensures GMQ is fully aligned with all external regulations (Health Authorities in global markets), the BMS Quality Management Systems (QMS) and has ownership, oversight and implementation accountability of quality systems and performance monitoring processes across the Global Manufacturing network (Internal and External) to leverage best practices and drive standard work across the enterprise.
Provides quality compliance expertise and guidance associated with internal and external Health Authority Inspection risks, quality and compliance performance management risks, and risk mitigation approaches to drive an increased Quality & Compliance Excellence culture.
Establishes Single Points of Contact (SPOC) for key partners and stakeholders representing GMQ, to contribute to Global Quality System, and Global Performance Management strategies across the enterprise.
Oversees the GMQ Quality & Compliance Excellence function mainly responsible for:
a. Oversight of the development, implementation, execution and performance of the various Level 2 processes of the BMS Global Quality Systems
b. Accountability for the Tier 2 GMP Quality Council and interconnectivity to the Tier 1 and Tier 3A GMQ Quality Councils
c. Management of the Network Health Authority Inspection Readiness program and processes
d. Oversight of targeted BMS Quality Systems (e.g. Network Supplier Quality) and electronic solutions across the GMQ Network
Oversees the GMQ Global Quality System implementation and performance:
a. Serves as SPOC for GQS to support Level 2 stage gates and implementation strategies.
b. Facilitates creation and/or optimization of the GMQ Global Quality Systems (GQS) champion and local process owner networks and governance.
c. Drives optimized GQS priorities implementation planning working closely with the GMQ internal and external operations.
d. Actively interacts with and supports the GMQ Business Unit VPs, the associated internal and external Site Quality Heads and their quality units.
e. Coordinates and leads GMQ QS continuous improvement/OPEX initiatives to enable efficiencies and compliance.
Oversees the GMP Tier 2 Quality Council and GMQ performance against established metrics:
a. Owns the Tier 2 Quality Council and enable Tier 1 Quality Council by analyzing Quality KPIs for the network and raising potential risks along with risk mitigation activities/proposals.
b. Manages and monitors performance of GMO network operational performance metrics through Quality Key Performance Indicators (KPIs), Quality System signals, and a healthy Quality Culture.
c. Ensures adequate linkages exist between the GMP Tier 1, Tier 2 and Tier 3 Quality Councils, including the compliance and supply risks.
Oversees the Management of the Network Health Authority Inspection Readiness program:
a. Leads a harmonized, Inspection Readiness effort leveraging existing risk management processes and tools to ensure top risks in GMQ are identified, tracked and mitigated.
b. Develops and/or optimizes tools to document, track and monitor risk mitigations; develops a process to implement risk mitigations across the enterprise.
c. Partners with BI&A to incorporate digitalization solutions to drive the evaluation and potential mitigations to inspectional risks.
d. Supports audits, Health Authority inspections and associated logistics when required, including assistance in the generation of HA responses and CAPAs.
Oversees targeted BMS Quality Systems and electronic solutions across the GMQ Network:
a. Manages the quality systems applicable to GMQ such as Supplier Quality, APQR, Product Disposition and specific improvement projects related to One QMS such as Deviation Excellence, Celgene integration, product quality complaints, etc.
b. Ownership of the Supplier Quality Program, including supplier lifecycle, material qualification, supplier change notification program, supplier Quality Agreements, supplier quality metrics, and supplier risk management program.
c. Leads the SAP-QM Data Steward and oversee data integrity program for GMQ.
d. Leads a GMQ IT network governance to ensure adequate oversight an decision-making for IT solutions.
Ensures GMQ Quality & Compliance Excellence has the required network interconnectivities and interdependence with the GMQ Support function(s) to ensure alignment with the GQ vision.
Creates global, Single Points of Contact (SPOC) for initiatives, activities and sister organizations (e.g. Operations, MS&T, Procurement, S&BO).
Actively interfaces with “End-to-End” GQ organization (e.g. GMQ, Global Quality Systems, Regulatory Compliance & External Engagement, etc.) to ensure alignment and consistency.
People Development and Organizational Management:
a. Develops and engages a right-sized global organization that can fully support GMQ.
b. Manager of Managers who builds strong organizational capability for current and future needs.
c. Recruits and develops global talent to sustain local and global competitiveness. This includes identifying individuals with leadership potential, providing mentoring and enrichment opportunities consistent with succession planning.
Advanced degree in science of pharmaceutical related fields (Chemistry, Pharmacy, Biology, and Chemical Engineering) preferred.
Minimum of 10 years of Biopharmaceutical experience in commercial manufacturing environments.
Strong understanding of Quality compliance processes and regulations, e.g. cGMP/GDP regulations
A thorough understanding of company policies and regulatory requirements, and their relation to the management and documentation of product quality investigations.
A 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.
Strategic thinker who sees the bigger picture and possesses high business acumen; understands how the parts impact the whole (end-to-end enterprise) and makes the best decisions for the whole.
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 the VP EXM Quality and interface with stakeholders in a matrix environment.
Ability to build strong, trusting relationships, lead large/complex programs, and work across divisions, diverse business backgrounds and cultures.
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.
Plans and organizes tasks and work responsibilities to achieve objectives; sets priorities; schedules activities.
Leads within the broader internal and external network and seeks to have impact on organization-wide performance.
Embraces complexity but strives for simplicity.
Shares resources and makes difficult trade-offs to benefit the organization at large.
Creates a vision for the future by spotting strategic opportunities for breakthrough performance.
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
Maintains a current and strategic view of talent management, aligned with the organization’s priorities.
Understands the needs and characteristics of the organization’s talent and the extent to which it supports the business agenda.
Proactively develops talent for the long and short-term, both within and outside their team.
Creates a learning environment that ensures people realize their highest potential.
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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