Senior

Senior Specialist, Quality Systems and Compliance

Leiden, NL · Hybrid

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. 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: careers.bms.com/working-with-us.

Position Summary

The Senior Specialist, Quality Systems and Compliance, is responsible for supporting the ownership and oversight of Quality Systems, per established local and global standards. This position supports the overall compliance and performance of the Quality Systems processes as they apply to the site level, including periodic assessments of process performance and continuous improvement opportunities.

This role also involves coordinating pre-inspection activities, streamlining information from various groups at both the site and global levels, and maintaining inspection readiness material content.

Duties/Responsibilities

Support the administration and maintenance of the Quality Systems, including metrics reporting and analysis, stakeholder communication, and governance meeting facilitation.
Supports, maintains and specializes in QMS systems and processes as applicable , such as Risk Management, E-Logbooks, Document and Records Management, Annual Product Quality Review and Quality Council.
Coordinate pre-inspection activities, including streamlining information needed from other groups at the site, and above-site (Global) level.
Support the site to prepare and execute corporate audits and Health Authority inspections for multiple markets.
Share data/ knowledge within and across site and network and participate in community of practices.
Build & maintain strong relationships with partner functions.
Lead meetings and represent function at cross functional and network meetings.
Identify improvement opportunities and drive team continuous improvement goals and projects related to the Quality Systems in scope for the site.
May act as subject matter expert and present Quality Systems overviews and related topics during audits and inspections.
Maintain compliance with assigned learning plan.
Support integration of newer team members
Supports Data Integrity Site Representative.
Perform any duties requested by management, after completing required training (if applicable).

Reporting Relationship

Senior Specialist, Quality Systems and Compliance reports into the Associate Director Quality Systems and Compliance.

Qualifications

Specific Knowledge, Skills, Abilities:

Ability to research, understand, interpret and apply internal policies and regulatory guidelines.
Proficient computer skills with knowledge of several digital tools like MS Office, etc., and ability to learn and work with new software applications.
Ability to interpret data & results, understand complex problems with multiple variables and critically assess and provide feedback on impact assessments and proposed actions.
Ability to critically review reports, interpret results and assess and challenge technical conclusions consistent with Quality risk management principles.
Excellent verbal and technical writing skills with ability to prepare written communications and present technical data to management with clarity and accuracy.
Ability to work in a fast-paced team environment and changing priorities.
Detail oriented and task focused with ability to meet deadlines and prioritize work.
Able to work across functional groups and teams to ensure requirements are met.
Self-motivated and contribute to a positive team environment.
Confident in making decisions for minor issues and able to recognize Quality issues and solve problems.
Curious and ability to think critically to create innovative solutions.

Education/Experience/ Licenses/Certifications:

Bachelor's degree preferred. High school diploma/ Associates degree with equivalent combination of education and work experience may be considered.
4+ years of experience in a regulated industry, preferably with 1+ year of quality system experience.
Experience in FDA/EMA regulations in biopharmaceuticals or cell therapy manufacturing is preferred.
Demonstrated proficiency with electronic system and databases.

Please note that this is an onsite role, and you will be required to work from the office 4–5 days per week.

#LI-Hybrid

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 a supportive culture, promoting global participation 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 an 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.

Supporting People with Disabilities

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 adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

Candidate Rights

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

If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/

Data Protection

We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at https://careers.bms.com/fraud-protection.

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

If you believe that the job posting is missing information required by local law or incorrect in any way, please contact BMS at TAEnablement@bms.com. Please provide the Job Title and Requisition number so we can review. Communications related to your application should not be sent to this email and you will not receive a response. Inquiries related to the status of your application should be directed to Chat with Ripley.

R1604283 : Senior Specialist, Quality Systems and Compliance