Director, GCP Quality

At Proclinical, we are seeking an experienced and successful individual to fill the role of Director of GCP QA, based in either San Francisco, CA or Boulder, CO. This responsibility will include the development, execution and maintenance of risk-based audit strategies, with a focus on internal and external GCP audits. Additionally, this role will bear the responsibility of the development, maintenance and improvement of departmental processes, fostering a compliant environment with internal and external groups.

Responsibilities

• Manage and/or participate in complex audits.
• Conduct GCP inspections.
• Develop of adequate and appropriate responses and resolutions to identified observations.
• Identify, communicate, and escalate GCP corporate risk and serious non-compliance situations and follow to resolution, acting at all times with an appropriate sense of urgency.
• Establish effective means for communicating audit and inspection outcomes, developing metrics, measuring trends and driving improvements thus identified.
• Attend relevant meetings to present quality system expectations and GCP training.
• Review all essential documentation prior to their Quality Assurance acceptance or approval.
• Oversee company-wide required annual GCP training.
• Remain up-to-date with the latest industry changes with regulatory requirements, industry standards and provide consultancy on quality/compliance/regulatory related issues.
• Represent GCP Quality Assurance on compliance-related projects and initiatives.
• Participate in the development and management of the departmental budget.

Skills And Qualifications

• BA or MA in related field and 15+ years of relevant scientific experience.
• Strong knowledge of the drug development process, trial design, data and trial management procedures.
• Experience in and knowledge of internal and external GCP auditing and quality systems operations.
• Experience leading regulatory authority inspections of clinical research activities.
• Hands-on experience managing quality and compliance-related projects and programs.
• Proven ability in driving GCP process improvement initiatives.
• Balanced approach to issue management and risk mitigation planning.
• Consistently and confidently exercise independent, sound judgment in making decisions.
• Current and in-depth knowledge of relevant global regulations and compliance initiatives.
• Strong knowledge of global health authority submission activities, specifically in relation to GCP.
• Excellent written, verbal, and interpersonal communication skills.
• Strong proficiency in Microsoft Office suite.
• Extensive experience in GCP auditing and managing regulatory authority inspections is required.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please call Kaye Dunleavy at (+1) 6463672646 or upload your resume on our website - www.Proclinical.com.

A full job description is available on request.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.