QA SAP - Senior Specialist

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

The BMS site of Boudry is a Manufacturing Site for Oral Solid Dosage Drugs and a Center of Excellence for projects and New Product Introductions (NPIs) relying on flexible manufacturing and testing operations. Currently, a Global ERP Integration project is on-going (switch from Oracle ERP to SAP ERP) at the Boudry site. The QA SAP Senior Specialist - Quality Projects & Vendors will join the Quality Assurance team of BMS, Switzerland.

The position is supporting all quality relevant activities (like change control, User Acceptance Test scripts writing and execution for SAP Quality Module) and is responsible for executing the review and approval of all relevant documents related to the implementation of the New SAP ERP at Boudry site.

You will be responsible and accountable for the tasks given below for BMS Boudry. The list of tasks is non exhaustive, according to business needs other tasks might be assigned to you.

Requirements

Will provide Quality & Compliance support to ensure conformance to cGxPs, guidance documents, applicable industry accepted standards and BMS requirements for the following task:

• Participate as Quality counterpart for the review and approval of change controls, deviations and documents (Standard Operating procedures, Work practices) related to the global project implementation,
• Execute Risk assessment as required.
• Write, execute, review and approve User Acceptance Test Script for the SAP Quality module.
• Participate to the update/creation of documentation related to the implementation of the quality module in SAP.
• Participate to the GMP readiness of the new ERP.
• Support the Quality validation team for the review / approval of qualification documents.
• The position holder will operate effectively and with minimal supervision, within a team or independently, performing projects related duties, as assigned.
• Promote compliance with data integrity and cGMP/GxP regulations.
• As required, provides QA support to SMEs to ensure the compliance to procedure / industry standards.
• Adherence to BMS core behaviours
  
  

Specific Knowledge, Skills, Abilities

• Good understanding of solid oral dosage form manufacturing, packaging and QC processes is a plus.
• Experience with Change Control, Deviation Management and Risk management Quality Systems.
• Experience in Quality end-to-end processes,
• Good understanding of Electronic Batch record (MES) or System Applications and Products in Data Processing (SAP) for quality related activities.
• Excellent analytical, interpersonal and communication skills, including written and verbal communication in French and in English.
• Works independently, yet effectively in a team environment.
• Able to deal with ambiguity and identify/mitigate risks.
• Strong sense of ethics, diplomacy and discretion
• Strong critical thinking to analyze complex situations and discern critical issues
• Knowledge of most common office software (e.g Microsoft Office word, excel, PowerPoint).
• Ability to collaborate various projects, create and work within internal timeliness, solve problems, deliver on commitments and utilize interpersonal skills in a cross-functional team,
• Excellent team player attitude
  
  

Education/Experience/ Licenses/Certifications

• University graduate (science degree preferred),
• At least 5 years of experience in Quality Assurance area related to qualification/validation in a pharmaceutical company or other regulated industry.
• Thorough understanding of cGMPs and Swiss, EU, and FDA regulatory requirements.
  
  

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

Physical presence at the BMS worksite or physical presence in the field is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture.

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.

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.