Main responsibilities:

Leads and defines the priorities and deliverables of Hubs, fostering a culture of quality and collaboration.
Provide Technical Support to Third Party Manufacturers and Contract Manufacturer Organizations, TPM/CMO Operations, Affiliates, and other Stakeholders.
Responsible for compliance with Corporate and Divisional QA policies, procedures, standards, and specifications as well as country specific regulations depending on the TPM/CMO location and markets. 
Manage supplier audit programs and follow-up on regulatory audits.
Provide an assessment of supplier’s quality in place with regards to material compliance, as well as regulatory of CAPA for Third Party sites.
Support audits lead by other auditors when specific expertise is needed.
Collaborate with stakeholders regionally for inspection preparedness.
About you

Experience: 4+ years in highly regulated medical industry (pharma is desirable), minimum 2 years of Quality, Regulatory & Compliance or Auditing experience (incl. preparation or  conducting on-site audits). Experience of supporting inspections and facing regulatory/health authority inspections/audits considered as added value, application of GMP requirements is a must. Willingness to frequent travel (up to 60%) as per business need.
Technical skills:Knowledge of cGMPs, Code of Federal Regulations in drugs and biologics, knowledge of CAPA systems is required and experience is desirable, knowledgeable in Quality functions of pharmaceutical industry.
Soft skills: Passionate, agile, ready to take action. Great problem solving and decision-making skills, proficient in problem-solving, attention to detail and good organizational skills.
Education: Master’s or Ph.D. in Life Sciences/Healthcare, or related technical field.
Languages: Excellent knowledge of English language (spoken and written). Other European languages are desirable.