Manufacturing Compliance Senior Specialist (R1550424-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.
The primary focus of the Manufacturing Compliance Senior Specialist, Manufacturing Compliance and Training is to support Manufacturing and ensure Jump Manufacturing inspection readiness. Including assisting with leading and driving the execution of Manufacturing Compliance deliverables according to established policies, procedures, and Current Good Manufacturing Practices (cGMP’s). The Manufacturing Compliance Senior Specialist works with and leads cross functional teams, builds and leads compliance programs and processes, collaborates with stakeholders and management, communicates project status and metrics, supports audits and regulatory inspections, and leads compliance evaluation of regulated activities within Manufacturing.
- Meets timelines without management oversite or intervention.
- Provides updates to management, partners with junior team members on obstacle resolution
- Participates in audit-readiness activities such as Gemba walks, storyboard creation, and back-room support
- Follows safety requirements, completes safety trainings, and escalates safety concerns.
- Recognizes and escalates potential deviations to management and forms a triage team
- Reviewing complex nonconformance/deviation investigations.
- Implementing effective corrective and preventative actions.
- Proposing/executing improvements through the change management system.
- Able to respond with a high degree of urgency to departmental and cross functional needs and requests.
- Reporting/Monitoring metrics on non-conformance investigations, corrective, and preventive actions (CAPA), and/or change management.
- Identifies and mitigates risks in manufacturing operations that could negatively impact delivery of safe and effective therapies to patients.
- Leads/participates in continuous improvement initiatives as part of BMS Bothell site’s commitment to operational excellence.
- Supports regulatory agency inspections.
- Actively pursues learning of required skills and new skills.
- Bachelors in relevant science or engineering discipline, or equivalent in work experience.
- 7+ years of experience in a Manufacturing setting.
- 5+ years of professional experience in project and/ or program management
- 3+ years of experience with technical process analysis and driving operational excellence and continuous improvement programs
Knowledge, Skills and Abilities:
- Ability to work with management and lead/ participate in cross-functional teams across the site
- Demonstrated proficiency in written and verbal communication at all levels within the organization
- Partner with manufacturing operations to manage stakeholder relationship
- Negotiates, collaborates, influences, and actively shares ideas with peers and management
- Demonstrated ability to effectively manage large scope and complex projects at a self-directed pace
- Acts with individual integrity and professionalism, and demonstrates ability to influence others to act with integrity and professionalism
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 email@example.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.
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