Director, R&D QA (GCP & PV)

Position Overview

Exciting opportunity for a Director to join the R&D QA team at Nektar.

This job contributes to and supports the companys research and development goal of creating high-value therapeutics by providing drug development programs with strategic GXP (GCP/GVP/GLP) compliance support.

This includes:

A) Conducting internal and external quality assurance audits to assess compliance with GCP/GLP/GVP requirements and guidelines, and ensures implementation of CAPAs to address audit findings;

B) Providing cogent analyses and guidance on the interpretation and application of GCP/GVP/GLP regulations to research activities;

C) Contributing to the design and review of nonclinical/clinical research protocols and supporting documents (eg.

informed consents) that are conducted under GCP/GVP/GLP regulatory requirements;

D) Developing and promoting GCP/GVP/GLP quality activities/initiatives that enhance Nektar’s drug development processes (eg.

Departmental SOPs/ Work Instructions); and

E) Collaborating with external service providers to help ensure the quality and integrity of services and deliverables.

Provides GCP/GVP/GLP training to functional areas and ensures the content satisfies regulatory requirements and Company needs.

Directly interacts with inspectors during regulatory agency GCP/GVP/GLP inspections of clinical and non-clinical Sponsor studies/activities and prepares follow-up responses to inspection findings.

Lastly, facilitates and helps manage due diligence activities associated with the outlicensing or partnering of Nektar products.

Works on issues where analysis of situations or data requires an in-depth knowledge of organizational objectives, compliance requirements as well as a scientific/clinical understanding of the clinical or non-clinical program.

Leads the conduct of internal and external audits to assess compliance with GCP/GVP/GLP regulatory requirements for Sponsor studies.

Provides Drug development Teams with clear and fact-based GCP/GVP/GLP audit results regarding the conduct of clinical or non-clinical studies.

Provides guidance to process owners so that effective corrective and preventative actions (CAPAs) are implemented to resolve areas of non-compliance.

Performs audits of data sources to assess integrity of research data and other data, as required, which support data summaries and conclusions for regulatory filings, due diligence, presentations/publications, etc.

May evaluate and select contract auditors to help perform required audits.

Develops proactive approaches to implement quality standards, including input to procedures and systems which support GCP compliance requirements for the conduct of clinical studies.

Provides training programs in functional areas involved in the execution of regulated activities.

Has liaison responsibility for interactions with regulatory agency inspectors during inspections of Sponsor studies/activities and coordinates follow-up actions and responses to address inspection findings.

Assesses deviations and determines adequacy of reporting and the potential impact on the study.

Provides guidance and information on (GXP) GCP/GVP/GLP regulations, standards, and quality systems.

Interacts with internal senior management and external service providers/CROs senior management on GCP/GVP/GLP quality matters.

Represents GCP/GVP/GLP compliance 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/GVP/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.

Directs and coordinates the activities of GCP/GVP/GLP quality projects with responsibility for results with relationship to cost, methods and employees.

Supports the implementation of quality improvement initiatives for company operations.

Directs operation and compliance activities with other applicable groups to establish timelines and accomplish tasks/projects.

This includes helping drive the development, content, and implementation of SOPs and Work Instructions within GCP/GVP/GLP Compliance and other Nektar Drug Development departments.

May direct other quality staff and/or functions.

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 10 years working experience in a Quality environment with expert knowledge and hands-on experience with GCP/GVP/GLP audits a must.

Comprehensive knowledge of GCP/GVP/GLP regulations and the ability to correctly interpret minimum standards are a must.

Experience with documentation systems, document review and auditing responsibilities is required.

Experience with clinical/non-clinical research/development and operations for execution of studies is required.

Working knowledge in quality sciences, statistics, and computer-based operations is required.

Must be highly detail-oriented and have a high analytical aptitude.

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.