Summary of Job

Emphasis for this position will be assuring GCP compliance through the coordination and execution of quality audits in support our routine audit and inspection readiness program.  Additionally, this individual will also be responsible to gather changes to global GCP related regulations. All GCP SOPs will need to be refreshed as a result of new ICH GCP regulations. Relevant expertise should include a strong technical knowledge as well as solid experience in the application of 21 CFR 11,50,54,56,312 regulations, ICH guidance’s, and MHRA regulations.

Essential Duties and Responsibilities

Consulting Assignment may include:

• Responsibilities include support activities for the external study audit programs, support for the external vendor qualification audit program, internal process audits for RegDev clients as well as participate in due diligence and regulatory inspections.
• Training/experience in the following areas of pharmaceutical industry-related expertise are a plus: -computer systems validation, 21 CFR Part 11 assessments-project management techniques.
• This candidate will have an auditing background, and ability to work/contribute in a team based environment as a lead and a participant, exceptional interpersonal skills that is comfortable working with cross functional departments and adept problem solving skills are strongly desired.
• The candidate will also have experience in the creation of standard operating procedures (SOP’s) and GCP Training Programs.

Job Requirements

Education:

• B.S.  in basic or applied science (chemistry, biological sciences, pharmacology, pharmaceutical science).

Experience:

• The successful candidate will have 5 years of experience working in a pharmaceutical Quality Assurance environment or related environment.
  • Background in leading and participation in audits with a GCP focus as well as a practical working knowledge of drug development and data management are necessary.

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 overseas travel.
• 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