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Sr. Manager Quality BMS Benelux – CLS EU Branch – Responsible Person NL

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

Job Title:

Sr. Manager Quality BMS Benelux – CLS EU Branch – Responsible Person NL

Employee, Full Time

Location(s): Utrecht, NL

Department Name: Supply Chain & In-Market Quality

Key Responsibilities and Major Duties:

The Sr. Manager Quality BMS Benelux / CLS EU Branch – Responsible Person NL is a position based in The Netherlands.

As Responsible Person, the Senior Manager is responsible for the activities in scope of the Wholesale Distribution Authorizations (WDA) of BMS Netherlands and BMS Celgene Logistics Sarl (CLS) EU Branch, in accordance with the EU Guidelines of Good Distribution Practices of Medicinal Products for Human Use.

More specifically:

Ensures that a Quality Management System is implemented and maintained in BMS Benelux as well as for BMS CLS EU Branch, including:

  • Maintaining Quality System Documentation: procedures and records
  • BMS Policy/Directives/SOPs impact assessment and implementation
  • GDP and Local regulations impact assessment and implementation
  • Focusing on the management of authorized activities and the accuracy and quality of records
  • Ensuring that initial and continuous GDP training programs are implemented and maintained.
  • Developing and maintaining the respective Quality Manuals
  • Ensuring that relevant customer complaints (incl. potential counterfeit) are dealt with effectively.
  • Performing periodic Self-Inspections according with the Self inspection plan
  • Ensuring implementation of Deviation and CAPA management
  • Ensuring implementation of the Change Control management
  • Leading/co-chairing the Quality Council meetings
  • Ensuring the reporting of quality metrics

Ensures implementation of following Quality Operations:

  • Supplier Management: Quality Agreements, approving any locally subcontracted GDP-activity which may impact product quality.  Evaluate and confirm the overview of the supplier qualification status.
  • Customer Qualification – approve new customers and periodic customer verification
  • Support investigations of GDP-compliance deviations and product quality issues with the relevant stakeholders.
  • Ensures proper escalation of quality incidents within quality, supply chain and the business.
  • Attends fact finding meetings when required and implements the defined action plans within the market.
  • Coordinates and promptly perform any market action operation, recall, for medicinal products. Mock recalls.
  • Supports Supply Chain to avoid back-orders.
  • Oversight on product quality status.  Maintenance and approval of the GDP-release register (Benelux)
  • Keeps appropriate records of any delegated duties.

Specifically for BMS Netherlands :

  • Approves returns to saleable stock, according to BMS requirements
  • Provide quality input on shortage situations and oversight reporting to Health Authority
  • Support Supply Chain to avoid Back Orders
  • Decides on the final disposition of rejected, recalled or falsified products.
  • Have oversight of the Third Party Logistics (3PL) and attend/ensure attendance in 3PL periodic Business Reviews for the Benelux
  • Representative for any communication with Health Authorities related to distribution and product quality defects
  • Provide back-up and support to Quality Operations of BMS Belgium.

Facilitate that BMS requirements are implemented in the Local Distribution Centre for:

  • Warehousing facilities
  • Transportation processes

Quality Risk Management

  • Coordination and preparation of Quality Risk Management
  • Participate in the periodic Business Reviews with the Distribution Center

Inspections and Regulatory Surveillance

  • Maintenance of the Wholesale Distribution Authorisations
  • Support Global Quality Audits
  • Preparation / coordinating Health Authority inspections
  • Anticipate new directives (Regulatory surveillance) and proactively drive change.
  • markets
  • BMS Netherlands representative for any communication with Health Authorities related to distribution and product quality

Quality representative supporting projects and services initiated by the commercial and supply chain organisation.

Key Stakeholders/Contacts:

Key internal stakeholders:

Global Quality Functions, Supply Chain functions, Regulatory team and Commercial organization including Operations, Brand teams, customer service team

Key external stakeholders:

Government Regulatory Authorities and Third Party Suppliers and Vendors

List of minimum requirements

Degree/Certification/Licensure

  • Must possess a Master's degree, preferably in Pharmaceutical Sciences (or in (Veterinary) Medicine, Chemistry, Biology, Biomedical) to be in line with EU Guideline of 5 November 2013 on Good Distribution Practice of Medicinal Products for Human Use (2013/C 343/01). Meeting requirements to take on the role of GDP Responsible Person in NL.

Required Competencies

Expected area of competence:

  • Leads and ensures the implementation and maintenance of quality management system, for the distribution activities with BMS product in the Market.
  • Attendance to complex issues impacting the market.
  • Identifies and communicates quality issues and decisions, which impact the business.
  • Ensures compliance of market Third Party Distribution partners to BMS Quality requirements related to distribution and transportation.
  • Embraces continuous improvement activities for more effective Quality systems across the organization.

Competencies – knowledge, skills, abilities, other:

  • Ability to develop and apply BMS operating philosophy and to operate within Company policies and procedures within Quality and Compliance area.
  • Ability to apply BMS Behaviors : Integrity / Innovation / Urgency / Passion / Accountability /Inclusion
  • Good verbal, written and presentation skills in English.
  • Innovative, creative and utilize available resources.
  • Strong working knowledge in PCs (experienced in Excel, Word, PowerPoint and SAP) and in Quality Systems
  • Team oriented worker with excellent interpersonal skills.
  • Ability to actively participate in projects within a multi-disciplinary environment, inquisitive, science technology oriented individual but practical.
  • Ability to collaborate and communicate directly and to actively participate in cross-functional and cross regional teams.
  • Negotiating skills for interfacing with Health Authorities and market business functions.
  • Ability to effectively communicate ideas and influence others to accomplish challenging goals and objectives.

Experience – Responsibility and minimum number of years

  • 5-7 years of progressive experience within the quality function of the pharmaceutical health care industry, preferably as RP.
  • Knowledge and experience in pharmaceutical health care operations, distribution and International regulations are essential.
  • Proficient in EU GDP guidelines and other EU and national legislation and requirements for pharmaceutical products distribution.

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.

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