$90,000 - $110,000 Relocation available

We are seeking a Senior Manager QA & Regulatory Affairs for our Contract Research Organization client that offers study services to the pharmaceutical industry.  The position can be based in either Houston or Pittsburgh.

Responsibilities:

• Ensuring our client's compliance with Standard Operating Procedures (SOP's) , FDA regulations and any other regulatory agencies.
• Overseeing Phase 1 operations, Clinical Trials and Data Management activities as well as Corporate activities.
• Providing direction to Institutional Review Board and overseeing all regulatory training aspects for the organization.
• Will lead and direct the Quality Assurance Department for 3 facilities.
• Responsible for reviewing the activities of the Quality Assurance department to ensure that appropriate quality reviews are conducted for all areas.
• Ensures company SOPs are written in accordance with current regulatory requirements. This also includes ensuring that critical areas of operations have adequate SOPs in existence to cover company from a regulatory standpoint.
• Provides support during any regulatory inspections such as FDA.
• Oversees SOP training, Good Clinical Practices (GCP's) training and any other training related to FDA, and other regulatory standards.
• Responsible for ensuring training files are in accordance with any regulatory standards.
• Provides oversight to the company Institutional Review Board for pending and ongoing trials as necessary.

Qualifications:

• Bachelors Degree in a scientific discipline, masters degree preferred.
• Must have extensive knowledge of GCP, ICH, FDA guidelines as well as other applicable regulatory requirements.
• 8- 10 years Regulatory or QA experience, GCP experience in clinical research preferred.
• At least 7 years managerial experience in an operations based environment.
• Prefer experience in Clinical Trials or a Hospital setting.
• Knowledge of Spreadsheet & Word processing software; Internet navigation

How to Apply

Qualified candidates please send a cover letter, resume and salary requirements to Ruth Frazer at ruth@pharmacruiting.com.