Director, Operational QA Network Management
Proclinical are partnering with a biotech organisation who are recruiting for an individual to join their team. This role is on a permanent basis. The opening position currently available is for a Director, operational QA Network Management.
- You will lead by example and be a proactive and visible Quality Leader.
- Communicate and direct decision-making procedures for network partners in GMP query, which involves onboarding partners, new products execution and technology transfer.
- Assist the responsible persons for release as the first QA expert contact for quality events.
- The ideal candidate will serve as a quality representative of the company within both external and internal manufacturing networks as a marketing authorisation holder.
- Train and teach QA Managers to accomplish the next level and develop themselves as QA experts within the manufacturing and testing operations.
- Guarantee assessment of quality events and notification from the network's partners.
- Implement and ensure seamless communication t the company's business partners, CMOs and internal divisions to guarantee product release in a compliant and timely manner.
- Other duties may be assigned.
Key Skills and Requirements:
- Educated to a degree level in a life science, engineering or medical discipline.
- Know-how of pertinent US and EU guidelines, EMA, FDA and any other regulatory standards as well as GMP.
- Demonstrable experience within quality assurance, quality oversight or corresponding, preferably within a biotech or pharmaceutical organisation with respective knowledge.
- Familiarity with both external and internal contract manufacturing organisations, which involves expertise on CMO operations and release testing.
- Works well with others both internally and externally in a cross-functional matrix team, as well as abilities in shareholder management.
- Tactical and operational abilities with the capacity to make flexible but thorough decisions in a dynamic setting.
- A high attention to detail.
- Fluency in both German and English.
- Presentation and communication skills both verbally and in writing towards a varied audience.
If you are having difficulty in applying or if you have any questions, please contact Josh Godden at firstname.lastname@example.org
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.