Makro Technologies: Director of GCP Compliance, Seattle, WA

Senior Manager / Associate Director / Director of GCP Compliance

Urgent requirement for one of our top clients located in Seattle, WA.

Description:
This position will be responsible for managing and maintaining the global GCP compliance program to ensure that clinical development is conducted in conformance with global regulatory requirements. This includes reviewing and auditing clinical operational systems (internal and external) impacted by European EMEA, ICH and US FDA regulations and extensive interaction and cooperation with clinical operations and regulatory functions to create a team approach to the evaluation. This position is also accountable for routine periodic reporting to management regarding audit findings and corrective action progress and the development and management of vendor qualification program including but not limited to pre-approval inspection readiness. This position will also manage GCP auditing staff.

Requirement: Requires BS in Life Sciences or health related field or equivalent and 8+ years of applicable experience required with at least 5 years experience in global GCP compliance auditing in the pharmaceutical industry. At least 2+ years management of audit staff; global management experience is highly desired. Experience in clinical operational or clinical trial management environment is a plus. GCP compliance training experience is required.

Contact:
The most effective way of communication is via email please forward us your updated WORD FORMAT resume (Address, Contact number and email is must), including position of interest and job No. SMGC_122907, to *** anitha.maturi@makrotech.com ***

Please mention your best hourly rate, availability and visa status. Any questions, do feel free to email us.

An equal opportunity employer, m/f/d/v.

Please reference BioTechPharmJobs.com when responding.