Director, GCP Compliance

Location
San Francisco, CA, United States
Posted
Nov 19, 2020
Ref
5119-545-2020
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time
Position Overview

Nektar has an exciting opportunity for a Director, GCP Compliance to join their team.

Overall responsibility for the conduct of internal and external audits to ensure compliance with current Good Clinical Practices (cGCP) in accordance with regulatory standards for clinical trials and to ensure integrity of clinical research data and other data to support regulatory filings. Develops proactive approaches to implement quality standards and procedures for cGCP regulatory compliance to meet company needs. Leads cGCP training of functional areas and develops training sessions. Oversees all interactions during regulatory agency inspections of clinical studies and GCP inspections, and all follow-ups to resolve inspection findings. Provides guidance on interpretation and application of cGCP regulations. Perform audits and define plans for contract auditors to proactively identify potential issues, and co-ordinates follow-up corrective actions. May help select, develop and evaluate personnel to ensure the efficient operation of the function.

Oversees the conduct of internal and external audits to ensure compliance with cGCP regulatory requirements for clinical trials, and implements corrective actions to resolve audit findings. Performs internal and external audits of data sources to ensure integrity of clinical research data and other data, as required, to support accuracy of data summaries and conclusions for regulatory filings, due diligence, presentations/publications, etc. Evaluates and selects contract auditors to help perform required audits. Develops proactive approaches to implement quality standards, including input to procedures and systems to support cGCP compliance requirements for the conduct of clinical studies. Develops cGCP training programs and leads training of personnel in functional areas involved in the execution of clinical trials. Overall liaison responsibility for interactions with regulatory agency personnel during their inspections of clinical studies, internally and at external sites, for GCP compliance and co-ordination of all follow-up actions and responses to resolve inspection findings. Determines, evaluates and investigates cCGP deviations and determines adequacy of reporting and the potential impact on the study. Provides guidance and information on cGCP regulations, standards, and quality systems. Interacts with internal senior management and external service providers/CRO's senior management on cGCP quality matters. Represents GCP function on various working teams, other functional areas and with external partners. Interacts with other Corporate Quality personnel to ensure alignment of quality standards and systems. Keeps current on changes in industry and regulatory standards for GCP requirements and advises on business impact. Participates with other senior managers to establish strategic plans and objectives. Makes final decisions on administrative or operational matters and ensures effective achievement of objectives. Works on complex issues where analysis of situations or data requires an in-depth knowledge of the company. Participates in corporate development of methods, techniques and evaluation criteria for programs, processes and people. Ensures appropriate documentation of activities is developed, implemented and maintained. Provides input to the preparation of documents for internal reports, external partner reports and/or regulatory filings. Directs and coordinates the activities of cGCP quality projects with responsibility for results with relationship to cost, methods and employees. Supports the implementation of quality improvement initiatives for company operations. Ensures budgets and schedules meet corporate requirements. Directs operation and compliance activities including selecting, training, supervision, mentoring, as well as, coordinates activities with other applicable groups to establish timelines and accomplish tasks/projects. Establishes, implements and maintains performance metrics. May direct other quality staff and/or functions. May be responsible for providing regular performance feedback, development and coaching to direct reports.

A minimum of a Bachelors degree in a scientific discipline is required; an advanced degree is preferred. Equivalent experience may be accepted. A minimum of 13 years experience in the pharmaceutical or other related industry is required. A minimum of 13 years working experience in a Quality environment with expertise knowledge and hands-on experience with cGCP audits is a must. A minimum of 10 years previous management experience may be required. Comprehensive knowledge of cGCPs regulations and the ability to correctly interpret minimum cGCP standards is a must. Experience with documentation systems, document review and auditing responsibilities is required. Experience with clinical research/development and operations for execution of trials
is required. Working knowledge in quality sciences, statistics, and computer-based operations is required. Must be highly detail-oriented. Strong verbal and written communication skills, as well as interpersonal and influencing are required. Must be goal-oriented, quality-conscientious, and customer-focused to deliver results. Experience working in a cross-functional team environment is required. Excellent computer skills are required. Up to 25% travel required.

We are an Equal Opportunity Employer and do not discriminate against applicants due to race, ethnicity, gender, veteran status, or on the basis of disability or any other federal, state or local protected class. Nektar Therapeutics will consider for employment qualified applicants with criminal histories in the manner proscribed by the San Francisco Fair Chance Ordinance.