Director QA and Compliance

Job Category: Clinical Operations
Contract type: Full Time
Experience: Director
Job Location: Zeist NL

We are actively looking for an experienced Director QA and Compliance. The purpose of the function is to provide leadership to the department Quality Assurance and General Compliance to assure and monitor the continuous quality deliverance of Julius Clinical and to ensure compliance with legislation and regulations. Reports into CEO of Julius Clinical.

Responsibilities:

  1. Provides strategic direction on all quality aspects of clinical trials set-up and management;
  2. Coordinates QMS review against the applicable legislation and regulations; Acts as first point of contact for clients regarding quality questions/issues;
  3. Identifies improvement possibilities for continuous development of Julius Clinical and is actively involved in improvement processes where needed;
  4. Ensures continuous coordination and implementation of external developments and regulations;
  5. Advises the MT of key quality risks and issues;
  6. Coordinates sponsor audits and inspections at Julius Clinical or at sites managed by Julius Clinical;
  7. Ensures an Annual Audit Program and General Compliance Program is in place;
  8. Ensures project-specific QA Management Plans are in place, if applicable;
  9. Analyses compliance trends identified in compliance checks and audits, and initiates improvement;
  10. Manages the internal CAPA program;
  11. Ensures new technologies and quality methods are implemented in the Julius Clinical QMS;
  12. Facilitates the creation of Quality Risk Assessments;
  13. Acts as line manager for the QA and General Compliance departments, including goal-setting, coaching and performance evaluation;
  14. Stimulates the development and evaluates the performance of the QA and General Compliance staff;
  15. Complies with and monitors the departmental budgets;
  16. Provides input to Business Development in clinical trial proposals.

Requirements:

  1. Higher level of education in a (preferably) (bio)medical field;
  2. Minimum relevant experience of 10 years in the pharmaceutical/CRO industry and 8 years within QA;
  3. Minimum of 5 years’ experience in international auditing (including vendors and sites);
  4. Extensive knowledge of GxP and other legislation and regulations relevant to Quality Management and Clinical Research;
  5. Ability to communicate and interact with (senior) management at partners and sponsors;
  6. Experience as a Project Manager and in international trials is preferable;
  7. Experience in line management of a team or department;
  8. Experience with regulatory inspections from a hosting perspective;
  9. Adequate command of written and spoken English.

Main competencies:

  1. Leadership;
  2. Ownership;
  3. Line management;
  4. Analytical thinking;
  5. Impact;
  6. Influence.

We offer:

An open and informal culture in a monumental building in Zeist. Flexibility in working from home and the office. Very committed colleagues wanting to contribute to unmet medical needs.

Questions:

Please contact Merel Schoonmade, Director HR

merel.schoonmade@juliusclinical.com or +31 6 28 25 67 23

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