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Global Quality Manager
hace 2 meses
Centrient Pharmaceuticals Netherlands is seeking a highly skilled and experienced professional to fill the role of QMS Manager. As a key member of the Global Quality team, the successful candidate will be responsible for defining, revising, and implementing a clear and robust document hierarchy for global documents.
Main Responsibilities- Document Hierarchy Development: Design and implement a clear document hierarchy for global procedures and policies, ensuring simplicity, effectiveness, security, and easy accessibility.
- Procedure Standardization: Standardize and harmonize global quality procedures and policies within the global quality organization, supporting training and implementation of these procedures.
- Quality Manual Revision: Revise or revisit the Quality manual and other GxP documents, standardizing, harmonizing, and/or simplifying as required.
- Regulatory Compliance: Ensure that procedures are current and suited to evolving GMP and regulatory requirements.
- Document Revision and Updating: Timely revision and updating of global documents.
- Quality System Development: Support development and continuous improvement of Centrient Quality Systems.
- Regulatory Support: Support leadership teams in regulatory inspections and customer audits.
- Training and Development: Support effective training of global procedures across Centrient Sites.
- Quality Audit Management: Lead and/or support GxP quality audits and monitor corporate annual audit plan.
- Education: Bachelor or postgraduate degree in Science, Pharmacy, or related field of study.
- Experience: 8-10 years of industry experience.
- Language Skills: Advanced level of English language (written and spoken).
- Regulatory Knowledge: In-depth knowledge of cGMP and regulatory requirements.
- Technical Writing Skills: Proven skills in technical writing.
- Leadership Skills: Prior experience in similar roles with good organization skills.
- Cultural Competence: International exposure and ability to manage cultural differences.
- Communication Skills: Ability to obtain commitment on required actions.
- Staying Current: Resourceful in finding and keeping abreast of the latest developments in the cGMP and regulatory environment.
