Manager of GCP Compliance (NJ) (FullTime)

Apply for this Job

Eyetech has an opening for an individual who will be responsible to prepare and conduct clinical and non-clinical study audits to assure compliance with all FDA regulations and ICH guidelines for Good Clinical Practices (GCP) and Good Laboratory Practices (GLP). The incumbent in this position will provide guidance to the Medical Department in the interpretation and application of pertinent US and International GCP regulations, coordinate the development of standard operating procedures, evaluate GCP training needs, plan and conduct domestic and international clinical compliance audits, assist in the development of corrective action plans and facilitate regulatory agency inspections. This position requires the participant to identify compliance risks and develop the basis for observations based on current regulations and internal quality standards. In addition to providing timely audit reports to Senior Management, the individual will be required to evaluate corrective action and collaborate with clients to ensure appropriate steps are taken to address corrective action plans. This role affords the individual the opportunity to participate in strategy sessions requiring the identification of risks and expert input so that the desired results are achieved.

Qualifications

• BS/BA in life science or equivalent.
• Minimum of 7 years of Biopharmaceutical experience, with an emphasis in clinical research, clinical monitoring, quality assurance or analytical laboratory operations.
• Thorough understanding of auditing processes in the drug development and approval process.
• In-depth knowledge and understanding of complex audits that require interpreting regulations, guidelines, and compliance issues.
• Excellent written and verbal communication skills.
• Ability to influence others and work as part of a collaborative team.
• Ability to travel approximately 25-30%.