Sr. Manager Quality BMS Benelux – CLS EU Branch – Responsible Person NL in Utrecht, Newfoundland

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 Obligations 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 data

  • BMS Coverage/Directives/SOPs affect evaluation and implementation

  • GDP and Native laws affect evaluation and implementation

  • Specializing in the administration of approved actions and the accuracy and high quality of data

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

  • Creating and sustaining the respective High quality Manuals

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

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

  • Making certain implementation of Deviation and CAPA administration

  • Making certain implementation of the Change Management administration

  • Main/co-chairing the High quality Council conferences

  • Making certain the reporting of high quality metrics

Ensures implementation of following High quality Operations:

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

  • Buyer Qualification – approve new prospects 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 reality discovering conferences when required and implements the outlined motion plans throughout the market.

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

  • 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 data of any delegated duties.

Particularly for BMS Netherlands :

  • Approves returns to saleable inventory, based on 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 Get together Logistics (3PL) and attend/guarantee attendance in 3PL periodic Enterprise Critiques for the Benelux

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

  • Present back-up and assist 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 Danger Administration

  • Coordination and preparation of High quality Danger Administration

  • Take part within the periodic Enterprise Critiques with the Distribution Heart

Inspections and Regulatory Surveillance

  • Upkeep of the Wholesale Distribution Authorisations

  • Help World 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 initiatives and providers initiated by the industrial and provide chain organisation.

Key Stakeholders/Contacts:

Key inner stakeholders:

World High quality Features, Provide Chain capabilities, Regulatory group and Industrial group together with Operations, Model groups, customer support group

Key exterior stakeholders:

Authorities Regulatory Authorities and Third Get together Suppliers and Distributors

Checklist of minimal necessities

Diploma/Certification/Licensure

  • Mustpossess a Grasp’sdegree,ideally in PharmaceuticalSciences(or in (Veterinary)Medication,Chemistry,Biology,Biomedical) to be in linewithEU Guidelineof 5 November2013onGoodDistributionPracticeof MedicinalProductsfor Human Use(2013/C343/01). Assembly necessities to tackle the position 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 advanced points impacting the market.

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

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

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

Competencies – information, abilities, skills, different:

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

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

  • Good verbal, written and presentation abilities in English.

  • Modern, inventive and make the most of out there assets.

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

  • Workforce oriented employee with wonderful interpersonal abilities.

  • Capability to actively take part in initiatives inside a multi-disciplinary atmosphere, inquisitive, science expertise oriented particular person however sensible.

  • Capability to collaborate and talk immediately and to actively take part in cross-functional and cross regional groups.

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

  • Capability to successfully talk concepts and affect others to perform difficult objectives and goals.

Expertise – Accountability and minimal variety of years

  • 5-7 years of progressive expertise throughout the high quality operate of the pharmaceutical well being care business, 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.

When 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 can be one step away from work that may rework your life and profession.

Uniquely Attention-grabbing Work, Life-changing Careers

With a single imaginative and prescient as inspiring as “Remodeling sufferers’ lives by science™ ”, each BMS worker performs an integral position in work that goes far past atypical. Every of us is empowered to use our particular person abilities and distinctive views in an inclusive tradition, selling variety 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 kind that you’re assigned is set by the character and tasks of your position:

Website-essential roles require 100% of shifts onsite at your assigned facility. Website-by-design roles could also be eligible for a hybrid work mannequin with no less than 50% onsite at your assigned facility. For these roles, onsite presence is taken into account an important job operate and is important 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 prospects, sufferers or enterprise companions and to attend conferences on behalf of BMS as directed is an important job operate.

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

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

BMS will take into account for employment certified candidates with arrest and conviction data, pursuant to relevant legal guidelines in your space.

Any information processed in reference to position functions will probably 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-Netherlands

Bristol Myers Squibb is an equal alternative employer. Certified candidates will obtain consideration for employment with out regard to race, coloration, 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 some other attribute protected by legislation.

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