Manager, Compliance Operations

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.

PURPOSE AND SCOPE OF POSITION:

The Manager, Supply Chain Program Management – Compliance Programs, will lead the S12 Site Supply Chain organization in the areas of cGMP documentation, maintaining department training and onboarding curriculums, governance of Site Supply Chain QMS records (Change Controls, Deviation and CAPA completion), inspection readiness efforts and site business continuity planning.

This position will provide indirect leadership to all Supply Chain functions when driving completion and closure of quality records, audit observations, and any compliance mitigation efforts.

This role will leverage knowledge of the BLA/NDA new product commercialization process, have strong familiarity working with supply chain, quality assurance (QA) and manufacturing functions. The Manager will be a key member of project teams that are led by cross-site communities within the Cell Therapy Development Organization (CTDO).

DUTIES AND RESPONSIBILITIES:

Key Responsibilities

• Manage and drive timely completion of department Deviations, CAPAs and Change Controls
• Manage a team responsible for compliance & operations initiatives within the organization
• Support site business continuity plan and Risk Assessments as SC SME
• Report and escalate on relevant Quality Management System (QMS) metrics, identifies problematic or overdue records and works with the area owners to drive towards resolution.
• Manage creation, implementation and compliance for documentation, procedures and policies.
• Ensures that the Site Supply Chain department is in a state of “Inspection Readiness.” This includes facilitating periodic SOP reviews and updates, storyboard creation and updates, and leads preparation activities for the department in the event of a scheduled inspection.
• Supports all Site Supply Chain functions by providing technical writing expertise and manages contract technical writing support as needed.
• Responsible for authoring responses to health authority inquiries and information requests as required.
• Review change controls and collaborate with specific Site Supply Chain functions to ensure appropriate actions are assessed and documented.
• Drives departmental training compliance and ensure that relevant curriculums are maintained.
• Participate in mock audits, document observations and issues, and drive relevant stakeholders to CAPA closures as required.
• Maintain departmental procedures, work practices and protocols. Perform periodic reviews and coordinate cross functional updates.
• Lead cross functional initiatives to evaluate, update and implement site business continuity plans by analyzing business risks and drive mitigation efforts
• Craft and maintain key partnerships across the organization’s support areas to ensure continuity planning and incident response
• Models the importance of GMP compliance and is a leader by example in this area.
• Communicate effectively to multi-functional and multi-location teams through team and individual settings

• Act as a change agent in a fast-paced environment to promote flexibility, creativity, and accountability
• Build a collaborative environment that fosters decisive decision making and accountability
• Build trust and productive relationships with peers and stakeholders
• Deliver business results through timely and quality decision making
• Fosters a culture of high ethics and compliance
• Promote a mindset of continuous improvement, problem-solving and prevention
• Create an environment of teamwork, open communication, and a sense of urgency
• Drive collaboration across the company and external partners
• Develop, maintain and actively manage relationships with support functions, customers and external partners to ensure productivity and collaboration
• Provide a safe and healthy work environment for staff within areas and ensure compliance with all appropriate policies and regulations
• Performs other tasks as assigned.

REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities:

• Advanced knowledge cGMP warehouse operations including best industry practices, application of principles, concepts, practices, standards, validation and qualification
• Advanced knowledge of cGMP/GDP/Pharmaceutical regulations
• Familiarity with health authority inspections and responses
• Proficiency in ERP systems / WMS Applications and analytics tools
• Proficiency in system and application use for business operations
• Advanced proficiency in MS Office applications
• Advanced analytical, problem-solving, and critical thinking skills
• Advance project management experience handling multiple projects simultaneously
• Advanced organizational and time management skills
• Strong written and verbal communication skills
• Strong presentation development and delivery skills
• Ability to adapt to changing business conditions while maintaining appropriate level of controls and compliance with regulatory requirements
• Demonstrated proactive, high attention to detail and follow-through
• Ability to work with people at varying levels within the organization and varying skillsets
• Ability to work independently and manage multiple tasks / timelines
• Ability to travel 5% - 10% of time

Education & Experience

• Bachelor’s degree in supply chain, engineering, life sciences, information systems, business management or related fields. Advanced degree preferred.
• 8+ years relevant work experience in a regulated pharmaceutical manufacturing environment.
• 2+ years leading/managing people
• Proven experience in supply chain, project management and production planning in a medium to high volume environment, knowledge of scheduling platforms.

WORKING CONDITIONS (US Only):

• The incumbent will be required to work in an office environment potentially requiring ergonomic considerations
• The incumbent will be required to work in a conference room environment for moderate periods of time.
• Occasional excursions to labs or production area requiring some level of gowning.
• Occasional domestic and international travel.
• Exposure to typical manufacturing, laboratory, mechanical and warehouse environments.

This job description is intended to describe the general nature and level of work being performed by the person assigned to this position. The primary duties and responsibilities are intended to describe those functions that are essential to the performance of this job.

This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. There are other duties and responsibilities that are considered incidental or secondary to the overall purpose of this job. Employees holding this position will be required to perform any other job-related duties as requested by management.

BMSCART VETERAN

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.

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