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(Senior) Manager Quality Management

Req #: 17001540
Location: Munich, BY DE
Job Category: Regulatory Affairs
Work Location: Joseph-Wild-Strasse 20 MÜNICH 81829
Organization: Celgene GmbH
Schedule: 40
Shift: Day Job
Employee Status: Full time
Job Type: Regular
Job Level: Individual Contributor
Travel: No
Other Locations:Germany- Munich

Description

Celgene is a global biopharmaceutical company leading the way in medical innovation to help patients live longer, better lives. Our purpose as a company is to discover and develop therapies that will change the course of human health.  We value our passion for patients, ​quest for innovation, spirit of independence and love of challenge. With a presence in more than 70 countries, and growing - we look for talented people to grow our business, advance our science and contribute to our unique culture.

Under the supervision of the Director Regulatory Affairs & Quality Management and within the framework of the global quality assurance functions this individual is in charge of all quality assurance related activities; responsible to co-ordinate with Technical Operations all quality activities in Germany and to manage relations with their stakeholders, in order to ensure the highest levels of pharmaceutical quality for Celgene products and appliance of procedures and quality regulations, especially GDP and the local requirements for wholesale distributors.

Responsibilities include but are not limited to:

Quality and compliance management

1. Is responsible for the maintenance of the Quality Management System (QMS) (includes the Quality Manual, Site Master File and all quality related processes)

2. Is responsible for the improvement of existing processes and the development of new processes or sub-processes related to the QMS

3. Ensures that corrective action plans are initiated and monitored and management is apprised of significant quality issues and progress

4. Identifies quality compliance gaps and weaknesses in operations

5. Process ownership for the Internal Audit Management (includes scheduling, planning, execution, evaluation and CAPA follow up)

6. Supports other units and Technical Operations in conducting internal or external audits

7. Performs SOP training and makes sure that all Celgene staff is trained accordingly

8. Is responsible for the product quality on a local level and is the point of contact in case of critical quality issues and recalls

9. Acts as the point of contact for the national competent authority

10. Reviews and comments technical agreements

11. Monitors national regulatory and legal requirements and communicates changes to the responsible person of wholesale and other concerned staff

12. Stays up to date on new regulations and GDP issues

13. Is the point of contact in questions regarding the wholesale license

14. Collaborates and participates in the quality network of Celgene within the limits agreed with their supervisor and represent quality interests in company’s working groups

15. Acts as quality management officer for the German organization, as described in the function related job description

16. Acts as deputy for the responsible person of wholesale according to the German drug law, as described in the function related job description

Knowledge management & Intelligence

Updates scientific and quality knowledge Contributes to the scientific, regulatory and quality information flow, by gathering, analyzing and communicating the defined information to interested parties, at an internal level Represents company’s interests with outside parties

Preferred Role Qualifications, Experience, Knowledge & Competencies

  • Strong identification with Celgene’s Values
  • Thorough working knowledge of local regulatory requirements in the pharmaceutical industry, especially GDP and the local requirements for wholesale distributors
  • Thorough working knowledge of the relevant sections of the EU regulation, EU directives and ICH guidelines
  • Pharmaceutical technical knowledge
  • Good working knowledge of quality management systems and ISO standards
  • Must have strong interpersonal skills, be a team player and be willing to work in an environment where individual initiative and accountability to the team are required
  • Strong organizational skills with the ability to prioritize and multi-task
  • Must be an individual with proven initiative and demonstrated accountability
  • Strong focus attention to details.
  • Ability to function productively in a fast paced and rapidly changing environment
  • A strong commitment to quality and patient safety
  • A good understanding of internal customer needs and project needs
  • Must be able to appropriately handle confidential information
  • Strong written and verbal local language and English communication skills
  • Knowledge of most common office software (Microsoft Office)

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About Celgene

Celgene is a global biopharmaceutical company committed to improving the lives of patients worldwide. At Celgene, we seek to deliver truly innovative and life-changing treatments for our patients.

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