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Job Opportunity

Job Opportunity
Associate Director of Quality Compliance
Aug. 09, 2021
Associate Director of Quality Compliance
Germany Wuppertal
Wuppertal
major responsibilities:

Reporting to the Head of Quality Compliance Europe, this role will ensure the highest standards of professional excellence, regulatory adherence and quality within the business, with overall responsibility and accountability to lead audits for our European sites in Ireland and Germany. Working closely with senior leaders in all areas of the business, this position will play an integral role in the development of the European quality compliance standards and internal audit procedures.

 

KEY RESPONSIBILITIES:

 

  •        Prepare and lead audits of European sites; perform consulting audits; follow-up on CAPA plans
  •        Contribute to the establishment of European regional quality compliance standards and internal audit procedures
  •        Support risk based quality system establishments and harmonization
  •        Prepare, review or provide input to cross-site SOPs within area of expertise
  •        Train and support sites operations to ensure compliance with relevant regulatory requirements and internal procedures
  •        Address any incompliance issues and follow-up on CAPA plans
  •        Support local teams to prepare/ manage regulatory inspections and customer audits; be part of the on-site audit team
  •        Provide supports for site’s critical deviation investigations and implementations of CAPA plans

 

 

qualifications requirements:

REQUIREMENTS:

 

  •        Advanced degree (Bachelor, Master or PhD) in Pharmacy, Biochemistry, Chemistry or other related scientific discipline
  •        Must be familiar with requirements of EMA & FDA regulations; ICH and WHO guidelines,
  •        Proven track record of successful EMA & FDA audit and inspection management
  •        Extensive working experience in QA and in the pharmaceutical industry with GMP standards
  •        Technical understanding of biologics, vaccine and other biotechnological manufacturing/testing processes preferable
  •        Good interpersonal communication skills
  •        Excellent oral & written communication skills in English (both English & German are preferable) 

 

Are you interested in becoming part of this culture and actively shaping the future of WuXi Biologics?  

Then please click the “Apply now” button.

We look forward to receiving your application documents, stating your salary expectations and the earliest possible starting date.

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