Executive Director, GCP & GLP Quality Assurance and Compliance

San Francisco, CA, United States
Jun 09, 2019
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time
Position Overview

The Executive Director, GCP & GLP QA and Compliance will provide strong leadership and clinical development experience to support the GCP compliance function.

Proactively assesses compliance issues and risks in development operations for Nektar, providing strong leadership and expertise in setting and maintaining the compliance standards of Nektar throughout Nektar's clinical development value chain, through to the patient. Provide strong leadership and clinical development experience to support the GCP compliance function and, in alliance with other functional areas, will establish comprehensive GCP quality processes and systems that support collaboration and compliance across an extended partner network. Assist with developing, implementing and communicating the strategic vision for GCP compliance to maximize employee focus, while maintaining a strong independent role for QA and compliance-related decisions. Review existing policies and procedures, identify gaps, and support operational departments in developing and communicating new and enhanced policies and procedures, including providing compliance support and advice to all aspects of Nektar's development operations.. Oversees the conduct of internal and external audits to ensure compliance with current Good Clinical Practices (GCP) and Good Laboratory Practices (GLP) in accordance with regulatory standards for clinical trials and nonclinical studies to ensure integrity of clinical and nonclinical research data to support regulatory filings. Organizes and performs audits and defines plans for contract auditors to proactively identify potential issues, and co-ordinates follow-up corrective actions. Develops proactive approaches to implement quality standards and procedures for GCP/GLP regulatory compliance to meet company needs. Facilitates GCP/GLP training of functional areas and/or develops training sessions. Laison responsibility for interactions during regulatory agency inspections of clinical studies and GCP inspections, as well as GLP inspections as needed, and coo-ordinates follow-ups to resolve inspection findings. Provides guidance on interpretation and application of GCP/GLP regulations. May help select, develop and evaluate personnel to ensure the efficient operation of the function. This job contributes to and supports the company's research and development efforts to create high value therapeutics to address unmet medical needs.

Interacts internally and externally with senior l management, requiring negotiation of extremely critical matters. Supports and assists VP GCP & GLP QA and Compliance in providing overall leadership for the GCP & GLP compliance function and, in alliance with the other functional areas, establishes comprehensive processes and systems that support collaboration. Assists in developing a robust clinical (GCP) quality system, provides business level leadership, fosters best practices, and mentors and consults on compliance techniques across the development and operations organizations. Supports clinical development teams in maintaining clinical compliance while remaining commercially competitive. Directly supports VP GCP & GLP QA and Compliance to lead change to enhance quality culture in the organization and to continuously adapt to a dynamic business environment; applies learning to enhance organizational performance. Assists in development and implementation of corporate and/or other organizational polices related to GCP/GLP compliance , including quality standards and SOPs. Oversees the conduct of internal and external audits to ensure compliance with GCP/GLP regulatory requirements for clinical trials and nonclinical studies, and implements corrective actions to resolve audit findings. Performs internal and external audits of data sources to ensure integrity of study data, including, clinical research data and nonclinical data, as required, to support accuracy of data summaries and conclusions for regulatory filings, due diligence actvities, presentations/publications. 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 GCP/GLP compliance requirements for the conduct of clinical studies. Facilitates GCP/GLP training of functional areas and/or develops training programs of personnel involved in the execution of clinical trials and nonclinical studies. 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. Also helps, as needed, with the interaction with regulatory agency personnel involved in inspections of nonclinical studies , as well as corrective actions. Determines, evaluates and investigates GCP/GLP deviations and determines adequacy of reporting and the potential impact on the study. Provides guidance and advice on GCP/GLP regulations, standards, and quality systems. Interacts with internal senior management and oversight of external service providers/CRO's senior management on GCP/GLP quality matters. May represent GCP/GLP function on various working teams, with 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/GLP requirements and advises on business impact. Participates with other senior managers to establish strategic plans and objectives. 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. Assists in the direction and coordination of the activities for GCP/GLP quality projects. Supports the implementation of quality improvement initiatives for company operations. Ensures budgets and schedules meet corporate requirements. Develops and maintains effective working relationships with stakeholder functions within Nektar and with local and global stakeholders in alliance managed partnerships to achieve GCP & GLP QA and Compliance goals. Identifies emerging trends / changes in GCP/GLP quality and redesignsprocesses and practices accordingly. Fosters an environment of collaboration, trust, quality, innovation and continuous improvement within the GCP & GLP compliance organization and between other functional departments. Leads operation and compliance activities including selecting, training, , mentoring, as well as, coordinates activities with other applicable groups to establish timelines and accomplish tasks/projects. May help recruit and direct, train/develop 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 15 years experience in the pharmaceutical or other related industry is required. A minimum of 18 years working experience in a GCP, Quality Assurance, or Clinical Operations environment with expertise knowledge and hands-on experience with GCP/GLP audits is a must. A minimum of 12 years previous management experience may be required. Comprehensive knowledge of GCP/GLP regulations and the ability to correctly interpret minimum GCP/GLP standards is a must. Knowledge of other regulations for pharmaceuticals, along with an understanding of global quality standards and regulatory authority inspection trends in relation to product development, submission and commercialization is required. Must understand all aspects of the pharmaceutical business, from research through sales and marketing, with the ability to operate cross-functionally and/or globally to achieve Nektar goals. Demonstrated ability to provide leadership for key strategic issues and significant quality policies, practices and processes with respect to quality compliance. Experience with process improvement techniques and practices such as Lean Six Sigma. Experience with preparing for and successfully managing regulatory inspections. Demonstrated ability to anticipate, proactively respond to trends and/or shifts in the external environment (e.g., regulatory, business partner relationships, industry standards). Strong verbal and written communication skills, as well as strong interpersonal and influencing skills are required. Proven ability to communicate in a strategic manner and influence decisions at a senior level, both internally and externally. Demonstrated ability to manage, develop and motivate Quality personnel, and work collaboratively across functional areas. Must be able to partner with a diverse group of staff/consultants with different strengths and skills and have the ability to prioritize work, manage multiple projects, while maintaining quality and strategic goals. Demonstrated ability to enlist input from stakeholders and constituents to make key decisions (e.g. tactics to accomplish goals), while ensuring final decisions are reached quickly and effectively, including situations with ambiguous data and/or uncertainty. 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.