Summary of Job

The current position for a Director of GCP QA Consultant will have primary assigned responsibilities in the areas of GCP QA and Compliance. The position requires both regional and globally focused operational skills in the reading and interpretation of the laws for regulatory compliance and US responsibilities. Moreover, s/he will provide GCP QA Quality and Compliance, Inspection Readiness and Auditing for RegDev clients.

Essential Duties and Responsibilities

• Manage ongoing GCP QA day to day activities associated with RegDev clients
• Conduct GCP Audits of Vendors, Investigator Sites and Internal Process Audits for RegDev clients.
• Conduct GCP Mock Inspections or Gap Assessment for RegDev clients.
• Support Inspection Readiness projects for RegDev clients.
• As requested, provide training for clinical sites and trial personnel to assure GCP compliance.
• Manage all aspects of GCP QA SOPs and support relevant SOPs development.

Job Requirements

Education:

• BS in scientific field; RN may be helpful.

Experience:

• 20 years or more in pharmaceutical company with specific GCP auditing experience at least 5 years.

Other Skills and Abilities:

• Excellent written and verbal communications. Powers of persuasion and negotiations, able to influence outcomes without authority. Full computer literacy.
• Full working knowledge of current regional regulatory laws and regulations and regulatory bodies and processes especially as related to regulatory compliance in GCP areas. Understanding of FDA and ICH guidance documents and requirements. Outstanding interpersonal skills, specifically able to take regulatory compliance positions within the company and with external persons such as investigators, and consultants. Must be able to resist pressure to waiver on company operational standards and expectation. Detail oriented. Flexible.

ADA Notations

• Ability to sit for long periods of time, handling, feeling with hands, reaching with arms.
• Regular communication (hearing/speaking).
• Approximately up to 30% domestic and international travel is required.
• Lifting up to 25 lbs.
• Routine home and onsite office duties including computer keyboard use.
• Vision requirements include close vision and ability to focus.
• Noise conditions range from quiet to moderate – home office conditions variable.

EQUAL OPPORTUNITY EMPLOYER