Job Details

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 Associated Director Quality Systems & Compliance is accountable for:

• leading a team covering operational GMP Compliance, Documentation and Training activities supporting Boudry manufacturing site and the two following entities Celgene International Sàrl I and Celgene International Sàrl II).
• the compliant implementation, alignment, continuous improvement and oversight of the Quality Systems & processes, including Documentation & Training systems in Boudry Internal Manufacturing site.
• ensuring compliance with regulatory requirements and adoption effective and efficient industry standard practices.

Though its mission to become a “Center of Excellence” for new products introduction, BMS Boudry manufacturing site will produce both Commercial and Clinical products. Thus, you will balance requirements and ensure a proper understanding of standards and regulation applicable to both types of production.

In particular, you will be responsible for the local site processes (Local process owners) for quality systems, complaints, documentation, training, internal audits, annual product review reporting and acts as contact person for Authority Inspections.

Skills/Knowledge Required

• BS in Pharmacy, Chemistry, Microbiology or related science, with 10 years of experience in a pharmaceutical company or other related industry, ideally in Quality Assurance.
• Excellent knowledge of and thorough understanding of cGMPs and FDA; EU, and Swiss compliance standards, regulation, and guidelines.
• Experience in operation is a plus.
• Ability to work in multi-cultural, matricial and cross-functional evolving environment
• Proven ability to drive changes
• Proven coaching and people management skills
• Excellent written & oral communication skills
• Knowledge of most common office software and IT principles
• Drive continuous improvement
• Fluent in French and English

Duties and Responsibilities

• Leads a cross-functional team covering operational Documentation & Training, Compliance activities and providing Quality Systems orientation and oversight.
• Ensures implementation and maintenance of an adequate, state-of-the art quality management system (QMS)..Management of Local Process owner (LPO) for key quality systems (Change Control, Deviation, CAPA, Compliant, Notification to management (NTM), Quality Council, Risk Management, Audits & Inspections, Annual Product Review)
• Lead the internal audit process and ensure appropriate execution. If appropriate, act as auditor/lead auditor.
• Lead the establishment of governance linked to key quality systems.
• Represent Quality organization in key global meetings such as Quality council.
• Responsible for issuing the Annual Quality Review Report and the Product Quality Review according to the Swiss-, EMEA- and FDA-requirements for assigned products.
• Assure site readiness for regulatory inspections including providing support for inspection preparation activities.     
• Identifies best practices both internally and external, through comprehensive bench marking, defines the implementation strategies and roll out.
• EHS- As Line Managers, provides a safe and healthy work environment for their staff in areas under their control and shall ensure compliance with relevant rules and legislation in those areas.
• Acts as deputy for the Head of Site Quality operations and colleagues within the leadership team and back up of the QP for release.

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 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.