QA Manager -GCP

QA Manager - GCP

 

The QA Manager –GCP oversees GCP QA activities, including arranging QA review of clinical and regulatory documents and leading auditing planning activities

Key Responsibilities

· Leads continuous improvement of GCP and GLP Quality Systems

· Performs audits as requested

· Leads Investigations of major deviationsIdentify, drive and implement improvements that result in sustainable compliance

Qualifications

· BA/BS degree in a scientific discipline or equivalent experience with minimum of 7 years in a pharmaceutical environment

· Experience interacting with Regulatory Agency Investigators

· Thorough understanding of GCP practices and US & ICH GCP regulations

· strong leadership skills and the ability to assess data as well as identify quality system trends

· Excellent oral and written communication skills and the ability to effectively manage multiple projects

· Thorough working knowledge of FDA and European regulations

If you are ready for a new challenge please submit a Resume to LifeCycle Pharma at vaw@lcpharma.com .  Please refer to “Job 139” in the subject line.