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Bristol Myers Squibb zoekt een

Specialist III, Manufacturing Compliance & Support

Leiden, Netherlands

Job Description

Working with Us
Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.

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. Read more: .

Department: Manufacturing – Compliance and Support
Job Title: Specialist III

Background: The Specialist, Manufacturing Compliance & Support contributes in a team that directly support Manufacturing floor operations. The Manufacturing Compliance team is a part of the overall manufacturing team and is organized around floor-enabling deliverables through compliance programs, quality systems, training, finite scheduling and equipment lifecycle support. We are looking for multiple specialist positions at different levels within this team.

Responsibilities (included but are not limited to):
· Drive specialist group to meet daily deliverables
· Coach and mentor junior specialist staff
· Provide front line support for manufacturing operations
· Support manufacturing continuous improvement projects
· Partner with Manufacturing Science and Technology team
· Investigates and coordinate the resolution of deviations through use of Root Cause Analysis tools and product impact assessments.
· Issues and implements CAPAs to address root cause and ensure effectiveness
· Collaborating with appropriate stakeholders to write and/or revise applicable SOPs, batch records, and other operational related documents
· Participates in internal audit/inspection
· Represents Manufacturing operations in Change Control, CAPA and Deviation meetings
· Conducts technical training for manufacturing operations
· Other tasks and duties as assigned by Management

Experience & Qualifications:
The ideal candidate for this position of Manufacturing Compliance and Support Specialist III is highly skilled flexible worker with strong people skills and an extensive background in cGMP manufacturing.
· Bachelor’s or Master's degree in sciences (for instance: Biochemistry, Life Science & Technology, Biology).
· A minimum of 7 years of cGMP production experience
· Strong analytical and problem-solving skills
· Strong leadership skills
· Sound knowledge and understanding of process, documentation requirements, systems and equipment to troubleshoot problems and provide solutions to management
· Knowledgeable of Current Good Manufacturing Practices (cGMPs)
· Expert knowledge of electronic quality systems.
· Knowledge of equipment and systems related to manufacturing operations (i.e. MES, eBR, Sepax, CliniMACs, LOVO, etc.)
· Knowledge of KPI generation and reporting
· Expert knowledge of quality record ownership (CAPA/CC/Dev)
· Experienced in providing and assessing performance related to manufacturing operation technical training

· Excellent verbal, technical writing and interpersonal skills
· Excellent communication skills in English, both written and spoken
· Comfortable in a fast-paced environment with minimal direction and able to adjust workload based upon changing priorities
· Ability to work efficiently and accurately on multiple projects simultaneously to meet set goals and timelines.

If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as “Transforming patients’ lives through science™ ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

On-site Protocol

BMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:

Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to . Visit eeo -accessibility to access our complete Equal Employment Opportunity statement.

BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.

BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

Blijf op de hoogte van de laatste farma vacatures


Blijf op de hoogte van de laatste farma vacatures