QA Director

Location: Massachusetts, USA
Job Type: Permanent
Specialisation: Life Sciences
Salary: Negotiable
Reference: 76965-PHARM-CKT_1603885620
Contact: Connor Harknett
Email: email Connor
I am currently looking for an Deputy QA Director in the Paris, France. Please see more below.


This opportunity is with a company who are experts in R&D and clinical development of life saving therapeutics. Leading programs in oncology (cell therapy), neurology, gene therapy and inflammatory diseases, with over 13 Phase 3 clinical studies in more than 30 countries.



Key Responsibilities:



You will have the freedom to promote a quality focused culture that allows continuous improvement across the functional areas of the business.


Acting as the Deputy QA Director (Associate Director), you will be tasked on your leadership and guidance duties during EMA and FDA health authorities inspections; training programs, responses to regulatory agencies and ensuring the QA team are well prepared for inspections/audits.



Have independence to develop and improve quality management systems for pre-clinical and clinical studies.



Recruit, develop and retain QA professionals, building a world class QA team.



Must be able to investigate and identify any quality related issues to ensure the correct solution is found.



Requirements:


Over 7 year's experience in a in quality assurance role with management experience.
Background in pharmaceutical company

Have experience dealing with EMA and FDA inspections

Worked within Biological Sciences or related field with an education or training in cell culture and gene therapy a plus

ASQ Auditor certification