Gevestigd apotheker Spits apotheek Alkmaar

Mwiah

Netherlands

Remote

EUR 90,000 - 150,000

Full time

14 days+
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Benefits offered by this job

Rémunération globale
Avantages sociaux complets
Couverture mondiale

Job summary

AmerisourceBergen recherche un responsable Qualité pharmaceutique pour diriger le système de gestion de la qualité et garantir la conformité réglementaire à l’échelle internationale. Le candidat mènera des audits et pilotera l’amélioration continue.

Le poste exige une expérience avérée dans un environnement pharmaceutique réglementé et une solide connaissance des régulations GDP et GMP, avec un leadership démontré et d’excellentes compétences en communication.

Qualifications

  • Master’s degree in Pharmacy with valid BIG registration.
  • Minimum 3 years in a regulated pharmaceutical environment.
  • Strong knowledge of GDP and GMP regulations.
  • Experience with audits and regulatory inspections.

Responsibilities

  • Assurer la qualité pharmaceutique et la conformité globale.
  • Développer, maintenir et améliorer le QMS.
  • Surveiller l’adhérence aux procédures et exigences réglementaires.
  • Porter le rôle de point de contact pour les questions liées à la qualité.

Skills

Leadership
Quality culture
Regulatory knowledge
Audit management
Stakeholder management
Analytical thinking
Process improvement

Education

Master’s Degree in Pharmacy

Tools

QMS
Validation

Job description

Cherchez-vous à faire une différence dans la vie d’un patient? Chez AmerisourceBergen, vous trouverez une culture innovante et collaborative, axée sur le patient et soucieuse de faire la différence. En tant qu’organisation nous sommes unis par notre responsabilité d’œuvrer pour des vies plus saines.

Ce que vous ferez
  • Ensure overall responsibility for pharmaceutical quality and compliance with applicable laws, regulations, and GDS standards
  • Develop, maintain, and continuously improve the Quality Management System (QMS)
  • Monitor and enforce adherence to procedures, policies, and regulatory requirements across the organization
  • Act as the primary contact for quality-related issues, including customer complaints and regulatory inquiries
  • Approve validation, calibration, and deblistering protocols, as well as procedural deviations and changes
  • Oversee and ensure proper handling of deviations, CAPAs, and recalls
  • Authorize release of packaging processes, validated equipment, and repackaged medication
  • Lead and support internal and external audits and maintain relationships with regulatory bodies
  • Provide leadership, coaching, and guidance to quality teams and broader organization
  • Promote a strong quality culture and continuous improvement mindset across all functions
  • Evaluate product changes, risks, and impacts related to pharmaceutical properties and packaging
  • Has authority to stop production and block products in case of quality risks
Requirements
  • Master’s Degree in Pharmacy
  • Valid and unrestricted registration in the relevant professional register (e.g., BIG register or equivalent)
  • Minimum 3 years of experience in a similar role within a regulated pharmaceutical environment
  • Strong knowledge of pharmaceutical regulations, GDP and GMP guidelines
  • Experience with Quality Management Systems and regulatory compliance frameworks
  • Experience working with audits and regulatory inspections
  • Proven experience in validation of equipment and software
  • Strong leadership and people management experience, including coaching and development
  • Experience in process improvement and organizational optimization
  • Excellent communication and stakeholder management skills
  • Strong analytical skills and ability to translate strategy into operational processes
  • Minimum Skills Required
  • Strong leadership and team management capabilities
  • Advanced knowledge of pharmaceutical quality standards and regulatory frameworks
  • Decision-making skills, including ability to act in critical or urgent situations
  • High attention to detail and problem-solving abilities
  • Strong analytical and critical thinking skills
  • Ability to influence and drive change within an organization
  • Excellent communication and collaboration skills
  • Organizational awareness and ability to navigate complex stakeholder environments
  • Results-oriented mindset with focus on continuous improvement
  • Fluency in English (written and spoken)
Ce qu’Cencora offre
  • Nous offrons une rémunération globale concurrentielle
  • Notre engagement envers nos associés comprend l’offre de programmes d’avantages sociaux complets, diversifiés et conçus pour répondre aux divers besoins de l’ensemble de nos associés
  • Grâce à notre présence mondiale et nos diverses unités commerciales, nous avons une approche équilibrée des avantages que nous offrons
  • De nombreux avantages sociaux sont payés par l’entreprise, tandis que d’autres sont offerts par les cotisations des associés
  • Les offres d’avantages sociaux spécifiques peuvent varier selon l’emplacement, le poste ou l’unité d’affaires

Temps Plein Affiliated Companies Affiliated Companies: Alliance Healthcare Management Services Limited

Égalité d’accès à l’emploi

AmerisourceBergen s'engage à offrir des possibilités d'accès à l'emploi égales sans égard à l’origine ethnique, à la couleur, à la religion, au sexe, à l’orientation sexuelle, à l’identité de sexe, aux renseignements génétiques, à la nationalité, à l'âge, aux handicaps, au statut de vétéran ou à l’adhésion à toute autre classe protégée par la loi fédérale, d’État ou locale.

Cencora is a leading global pharmaceutical solutions company that is committed to improving the lives of people and animals everywhere. We connect manufacturers, providers, and patients to ensure that anyone can get the therapies they need, where and when they need them. We’re a purpose-driven organization, where all of our team members around the world are united in our responsibility to create healthier futures. We work together every day to help our partners bring their innovations to patients worldwide, creating unparalleled access and impact at the center of health.

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