Location: El Segundo, CA
Start Date: Oct 21, 2019
Apply Now Sign Up For Job Alerts Email Job Refer a Friend Apply with LinkedIn
El Segundo, CA
Pay up to: $155K
The GCP Associate Director role provides leadership and ensures compliance witht entities standard operating procedures, ICH and US FDA regulations and guidelines, and clinical study protocols. This role participates in the development, implementation, and maintenance of the corporate GCP Quality Management System and training program. Strong communication skills are needed, with the ability to build internal and external relationships including interactions with clinical investigators and their staff concerning GCP matters, contract research organizations, and clinical laboratories
The successful candidate demonstrates GCP QA leadership, is proficient in communication (written and verbal), multitasks across multiple functional areas, is timeline focused and flexible in their work scheduling to meet the demands of a multi-product clinical phase pharmaceutical company that is transitioning to the commercial phase.
Lead a team of direct reports and actively manage the team's workload and provide coaching and development.
Direct investigations and resolution of non-conformances and ensure that appropriate and timely corrective and preventive actions are implemented and documented
Ensure timely review and approval of QA activities and documents
Assist in the implementation of Quality Assurance strategic initiatives
Develop, monitor, and report the status of compliance metrics
Leading Change Control assessments and managing subsequent QA deliverables.
Supporting IND and NDA/BLA preparation and Audit readiness initiatives.
Performing work that consistently requires independent decision making and the exercise of independent judgment and discretion
Ensure Corporate compliance with SOPs and GCP regulations
Conducts Quality Oversight of all study activities and provides risk mitigation strategies.
Lead and coordinate diverse Audits and Compliance visit monitoring activities.
Performs extensive quality reviews of monitoring reports, on-site activities and electronic data capture (EDC). Perform qualification, and routine compliance audits of clinical sites and clinical suppliers (CROs, phase 1 units, IRBs, data processing, etc.)
Independently schedule, plan, coordinate and conduct internal system, and clinical trial site audits
Accountable for the accuracy of audit findings.
Maintain all associated department spreadsheets, tracking of audit findings, and audit files as applicable
Participate in solving GCP compliance issues within Quality Assurance, Clinical Operations, Regulatory Affairs, Medical Affairs, and Pharmacovigilance.
Support joint efforts in training on company procedures, GCP regulations, and documentation systems to assure compliance with company policies and regulatory standards.
Bachelor's/Master degree in science or equivalent, with 12+ years of experience
Must possess knowledge of US FDA regulations, International Conference on Harmonization (ICH) and EU GCP regulations and guidelines to act as a resource for colleagues
Experience in Phase 1-4 clinical trials
Ability to effectively plan and organize work activities and prioritize task completion to meet schedules and deadlines
Strong problem solving and analytical skills with demonstrated ability to be detail oriented; while managing multiple projects simultaneously
Ability to identify improvements that enhance the clinical trial quality system.
Must be able to exercise judgment in ensuring that written procedures are followed and in evaluating quality systems, processes, procedures, and protocols for compliance.
Inspection experience in hosting or supporting regulatory authority inspections (US FDA, EMA, MHRA)
Strong Communication skills (written and verbal), interpersonal and problem solving skills and detail oriented
40-50% travel may be required.
Complete understanding and application of ICH GCP R2
CQA or other audit certifications is a plus
Knowledge of TMF or electronic document management systems is a plus
Be a part of the ConsultNet difference. As a leading national provider of IT staffing and solutions, ConsultNet delivers exceptional services to startup, midmarket and Fortune 1000 companies across North America. Since 1996, we've partnered with clients to create rewarding opportunities for our consultants, successfully building teams that have surefire results.
In the past two years alone, we have placed more than 1,500 consultants in contract, contract-to-hire, or direct placement opportunities. We understand communication is key to finding the right job that matches your skills and career goals. For us, it's not just the work that we do; it's how we do the work. Our breadth of offerings extends to multiple IT positions in major markets throughout the country, see more at www.consultnet.com