Manufacturing Compliance Associate II/III - Project and Change Management (R1550463-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 core role of the Manufacturing Compliance Associate II/III is to work within quality systems to support and lead projects under limited direction of senior members of the team. The Compliance Associate performs effective scoping, planning, initiation, and execution of changes. This role requires the employee to be trained in and operating in 3+ quality systems in which they own and complete quality system records on behalf of the Manufacturing organization. This role requires the employee to maintain an audit-ready state of compliance with assigned quality system activities and training requirements, as well as participating in audit readiness activities.
- Owns and completes records in 3+ quality systems: CAPA, Change Control, EDMS, QRM, Training.
- Represents department in cross-functional teams in support of process improvement and product lifecycle management initiatives by providing SME input and taking ownership of project deliverables.
- Leads cross-functional team meetings to enable successful planning, initiation, and execution of changes.
- Meets timelines under active supervision of senior team member or management with minimal oversite.
- Identifies and escalates obstacles to project completion to management.
- Remains in an audit-ready state of compliance, including on time quality system record processing and training assignment completion.
- Participates in audit-related activities such as backroom support, supporting audit pre-requests, and supporting changes in response regulatory agency feedback, as required.
- Follows safety requirements, completes safety trainings, and escalates safety concerns.
- Bachelors in relevant science or engineering discipline, or equivalent in work experience.
Qualifications & Experience
- 4+ years of experience in a GMP Quality or Manufacturing setting.
- 2+ years of experience working with Quality Systems.
Knowledge, Skills, and Abilities
- Ability to work within cross-functional teams
- Demonstrated proficiency in written and verbal communication
- Demonstrated organizational skills
- Negotiates, collaborates, influences, and actively shares ideas at the peer level within their department and cross-functionally at the site.
- Demonstrates individual accountability and responsibility while also taking ownership of responsibilities.
- Acts 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 firstname.lastname@example.org. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.
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