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

Bristol Myers Squibb

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Job Title:

Sr. Supervisor High quality BMS Benelux – CLS EU Department – Accountable Particular person NL

Worker, Full Time

Location(s): Utrecht, NL

Division Title: Provide Chain & In-Market High quality

Key Tasks and Main Duties:

The Sr. Supervisor High quality BMS Benelux / CLS EU Department – Accountable Particular person NL is a place primarily based in The Netherlands.

As Accountable Particular person, the Senior Supervisor is accountable for the actions in scope of the Wholesale Distribution Authorizations (WDA) of BMS Netherlands and BMS Celgene Logistics Sarl (CLS) EU Department, in accordance with the EU Tips of Good Distribution Practices of Medicinal Merchandise for Human Use.

Extra particularly:

Ensures {that a} High quality Administration System is applied and maintained in BMS Benelux in addition to for BMS CLS EU Department, together with:

  • Sustaining High quality System Documentation: procedures and information

  • BMS Coverage/Directives/SOPs affect evaluation and implementation

  • GDP and Native laws affect evaluation and implementation

  • Specializing in the administration of licensed actions and the accuracy and high quality of information

  • Guaranteeing that preliminary and steady GDP coaching packages are applied and maintained.

  • Creating and sustaining the respective High quality Manuals

  • Guaranteeing that related buyer complaints (incl. potential counterfeit) are handled successfully.

  • Performing periodic Self-Inspections in accordance with the Self inspection plan

  • Guaranteeing implementation of Deviation and CAPA administration

  • Guaranteeing implementation of the Change Management administration

  • Main/co-chairing the High quality Council conferences

  • Guaranteeing the reporting of high quality metrics

Ensures implementation of following High quality Operations:

  • Provider Administration: High quality Agreements, approving any domestically subcontracted GDP-activity which can affect product high quality. Consider and make sure the overview of the provider qualification standing.

  • Buyer Qualification – approve new clients and periodic buyer verification

  • Help investigations of GDP-compliance deviations and product high quality points with the related stakeholders.

  • Ensures correct escalation of high quality incidents inside high quality, provide chain and the enterprise.

  • Attends truth discovering conferences when required and implements the outlined motion plans inside the market.

  • Coordinates and promptly carry out any market motion operation, recall, for medicinal merchandise. Mock recollects.

  • Helps Provide Chain to keep away from back-orders.

  • Oversight on product high quality standing. Upkeep and approval of the GDP-release register (Benelux)

  • Retains applicable information of any delegated duties.

Particularly for BMS Netherlands :

  • Approves returns to saleable inventory, in response to BMS necessities

  • Present high quality enter on scarcity conditions and oversight reporting to Well being Authority

  • Help Provide Chain to keep away from Again Orders

  • Decides on the ultimate disposition of rejected, recalled or falsified merchandise.

  • Have oversight of the Third Occasion Logistics (3PL) and attend/guarantee attendance in 3PL periodic Enterprise Evaluations for the Benelux

  • Consultant for any communication with Well being Authorities associated to distribution and product high quality defects

  • Present back-up and help to High quality Operations of BMS Belgium.

Facilitate that BMS necessities are applied within the Native Distribution Centre for:

  • Warehousing services

  • Transportation processes

High quality Threat Administration

  • Coordination and preparation of High quality Threat Administration

  • Take part within the periodic Enterprise Evaluations with the Distribution Middle

Inspections and Regulatory Surveillance

  • Upkeep of the Wholesale Distribution Authorisations

  • Help International High quality Audits

  • Preparation / coordinating Well being Authority inspections

  • Anticipate new directives (Regulatory surveillance) and proactively drive change.

  • markets

  • BMS Netherlands consultant for any communication with Well being Authorities associated to distribution and product high quality

High quality consultant supporting tasks and companies initiated by the business and provide chain organisation.

Key Stakeholders/Contacts:

Key inner stakeholders:

International High quality Capabilities, Provide Chain features, Regulatory group and Business group together with Operations, Model groups, customer support group

Key exterior stakeholders:

Authorities Regulatory Authorities and Third Occasion Suppliers and Distributors

Record of minimal necessities


  • Mustpossess a Grasp’sdegree,ideally in PharmaceuticalSciences(or in (Veterinary)Drugs,Chemistry,Biology,Biomedical) to be in linewithEU Guidelineof 5 November2013onGoodDistributionPracticeof MedicinalProductsfor Human Use(2013/C343/01). Assembly necessities to tackle the function of GDP Accountable Particular person in NL.

Required Competencies

Anticipated space of competence:

  • Leads and ensures the implementation and upkeep of high quality administration system, for the distribution actions with BMS product within the Market.

  • Attendance to complicated points impacting the market.

  • Identifies and communicates high quality points and choices, which affect the enterprise.

  • Ensures compliance of market Third Occasion Distribution companions to BMS High quality necessities associated to distribution and transportation.

  • Embraces steady enchancment actions for more practical High quality techniques throughout the group.

Competencies – information, abilities, skills, different:

  • Potential to develop and apply BMS working philosophy and to function inside Firm insurance policies and procedures inside High quality and Compliance space.

  • Potential to use BMS Behaviors : Integrity / Innovation / Urgency / Ardour / Accountability /Inclusion

  • Good verbal, written and presentation abilities in English.

  • Modern, artistic and make the most of accessible sources.

  • Robust working information in PCs (skilled in Excel, Phrase, PowerPoint and SAP) and in High quality Techniques

  • Workforce oriented employee with wonderful interpersonal abilities.

  • Potential to actively take part in tasks inside a multi-disciplinary setting, inquisitive, science expertise oriented particular person however sensible.

  • Potential to collaborate and talk straight and to actively take part in cross-functional and cross regional groups.

  • Negotiating abilities for interfacing with Well being Authorities and market enterprise features.

  • Potential to successfully talk concepts and affect others to perform difficult objectives and targets.

Expertise – Duty and minimal variety of years

  • 5-7 years of progressive expertise inside the high quality perform of the pharmaceutical well being care trade, ideally as RP.

  • Information and expertise in pharmaceutical well being care operations, distribution and Worldwide laws are important.

  • Proficient in EU GDP tips and different EU and nationwide laws and necessities for pharmaceutical merchandise distribution.

In the event you come throughout a job that intrigues you however doesn’t completely line up together with your resume, we encourage you to use anyway. You could possibly be one step away from work that can rework your life and profession.

Uniquely Fascinating Work, Life-changing Careers

With a single imaginative and prescient as inspiring as “Remodeling sufferers’ lives by means of science™ ”, each BMS worker performs an integral function in work that goes far past odd. Every of us is empowered to use our particular person abilities and distinctive views in an inclusive tradition, selling range in scientific trials, whereas our shared values of ardour, innovation, urgency, accountability, inclusion and integrity carry out the very best potential of every of our colleagues.

On-site Protocol

BMS has a various occupancy construction that determines the place an worker is required to conduct their work. This construction contains site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy sort that you’re assigned is decided by the character and tasks of your function:

Web site-essential roles require 100% of shifts onsite at your assigned facility. Web site-by-design roles could also be eligible for a hybrid work mannequin with at the least 50% onsite at your assigned facility. For these roles, onsite presence is taken into account a necessary job perform and is vital to collaboration, innovation, productiveness, and a constructive Firm tradition. For field-based and remote-by-design roles the power to bodily journey to go to clients, sufferers or enterprise companions and to attend conferences on behalf of BMS as directed is a necessary job perform.

BMS is devoted to making sure that folks with disabilities can excel by means of a clear recruitment course of, cheap office lodging/changes and ongoing help of their roles. Candidates can request an affordable office lodging/adjustment previous to accepting a job provide. In the event you require cheap lodging/changes in finishing this utility, or in any a part of the recruitment course of, direct your inquiries to [email protected] . Go to ( eeo-accessibility to entry our full Equal Employment Alternative assertion.

BMS cares about your well-being and the well-being of our employees, clients, sufferers, and communities. Consequently, the Firm strongly recommends that each one staff be absolutely vaccinated for Covid-19 and hold updated with Covid-19 boosters.

BMS will think about for employment certified candidates with arrest and conviction information, pursuant to relevant legal guidelines in your space.

Any information processed in reference to function functions might be handled in accordance with relevant information privateness insurance policies and laws.

Firm: Bristol-Myers Squibb

Req Quantity: R1579188

Up to date: 2024-04-08 12:40:48.979 UTC

Location: Utrecht-NLD

Bristol Myers Squibb is an equal alternative employer. Certified candidates will obtain consideration for employment with out regard to race, colour, faith, intercourse, sexual orientation, gender id, nationwide origin, age, incapacity, protected veteran standing, being pregnant, citizenship, marital standing, gender expression, genetic info, political affiliation, or every other attribute protected by legislation.

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