|Job title :||Senior Manager GCP Audit|
|Job type :||Permanent|
|Salary :||€90000 - €105000 per annum + package dependent on candidate location|
|Contact name :||John Spring|
|Contact number :||+41 (0) 44 5803 717|
|Contact email :||firstname.lastname@example.org|
I am working on behalf of a long-term global pharma partner who are leaders in their fields, primarily in cancer treatments and cardiovascular products. The company are experiencing a period of sustained growth globally and are looking to add a highly skilled, dedicated and passionate GCP QA Senior Manager to play a key role in the global GxP QA Auditing Team.
Salary & Benefits:
Dependent on location; full details of salary, bonus and benefits on request
Role and responsibilities:
*Responsibility for assuring quality management for all aspects of GCP relating to health authority and regulatory inspections as well as vendor and clinical sites.
*Management of a global GCP audit programme, working closely with the GxP QA Senior Management Team, including audits through phase I to IV, supporting clinical development and discovery.
*Lead investigator site audits, internal systems and processes as well as service provider audits, ensuring compliance to global and local regulations and guidelines.
*Support and lead GCP regulatory inspections for CROs, vendors and sponsor facilities.
*Management of QA documentation supporting audits, including CAPA, continuous process improvements and SOPs.
*Metrics management: implement systems to track metrics for audit follow ups.
*Expected number of audits per year - 15-20 with a global outreach.
Requires skills and qualifications:
*At least a Bachelor's Degree certification in a life science related discipline.
*Significant experience in GCP auditing; demonstrated over at least 5 years in the pharmaceutical or biotechnology industry.
*Significant experience in hosting regulatory authority inspections.
*Lead auditor certification preferred.
*Global experience and ability to travel internationally up to 30% of the time.
This is a fantastic position within a company that has demonstrated continued growth over the past few years. The company are leading the way in cutting edge medical technology, with an exciting pipeline and a global outreach. This opportunity will give the chance for a clear, mapped out career progression plan, and the chance to be part of something truly special in the industry.
To apply for this position and put yourself under immediate consideration, send your CV to email@example.com or call +44 (0) 207 255 6650