Job Details

Associate Director, Senior QP, Pharmaceutical QP Operations

Quality

icon-location-marker Utrecht - NL
Posted 5 days ago Full_time R1583741

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 Senior QP - QP Operations Pharmaceutical Quality will work independently on behalf of the QP organization to provide conceptual and practical expertise in QP requirements and ways of working.  They will use best practices and knowledge of internal or external business issues and the regulatory landscape to improve products/services or processes across the business. They will typically resolve complex problems or problems where precedent may not exist and represent the QP team on cross functional projects.  

The Qualified Person is invested with the authority to make decisions with regards to product quality, safety, purity, and efficacy independent of other business interests

  • EU QP Certification of non-Sterile and Sterile pharmaceutical products for the EU/EEA and ROW markets which have been manufactured and checked in accordance with its marketing authorization, the principles and guidelines of GMP as laid down in Directive 2003/94/EC and other relevant legal requirements
  • Continually maintain familiarity with the manufactured and tested requirements specified in the Market authorisation, national legislation or cGMPs for all products under their remit as per the MIA. .
  • Guidance and support of the Quality Operations teams to support batch certification activities.
  • Actively support the BMS Fact Finding Investigation Teams (FIT), Fact Finding review Meetings (FIRM) and Product Review Committee (PRC) processes for investigations.
  • Collaboration with launch excellence and other functional areas to support new product introductions and new market launches
  • Participate in regulatory and corporate audits as required.
  • Participation in the product recall process and Competent Authority notification process.
  • Undergo continuous professional development including self- study, site visits, internal and external training courses to keep abreast of current trends in manufacturing technology, GMP and regulatory affairs.
  • When operationally required this role will have people management responsibilities to manage a team of Senior Manager, Qualified Persons and other Quality professionals. 

Requirements

In addition to the BMS Core behaviors, the job holder should exhibit; 

  • Effective interpersonal, oral, and written communications skills in person or virtual environments 
  • The job holder must demonstrate an ability to coach and mentor others, as well as be able to prioritise objectives from multiple projects. 
  • Excellent communication and ability to contribute to and lead team based in collaborative environment is essential. 
  • Proactive in resolving issues and escalating to management when necessary 
  • Must lead by example in terms of displaying the BMS behaviors 
  • EU/EEA QP Eligible, MSc (or equivalent) in a technical or scientific discipline which meets educational requirements as described in Article 49 2001/83/EC 
  • Minimum 10 years experience directly related to the role in a regulated environment including audit, batch record review, change control, complaint handling and investigations experience 
  • Minimum 2 years experience as an actively releasing QP 
  • A clear understanding of cGMP requirements for manufacturing and/or systems and compliance to include a good knowledge of the dosage forms within the scope of responsibility
  • Demonstrated proficiency communicating and collaborating at a variety of levels and across divisions and with external parties including health authorities 
  • Demonstrated ability to recognise issues, highlight risks and prioritise workload based on schedule requirements 
  • Proven success working well in a team environment with flexibility to react to changing business needs

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.