Sr. Manager, R&D QA

Location
San Francisco, CA, United States
Posted
Oct 13, 2020
Ref
5200-545-R
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time
Position Overview

Nektar has an exciting opportunity for a Sr. Manager, R&D QA to join their team.

This job contributes to and supports the company's research and development goal of creating high-value therapeutics by providing drug development programs with strategic GCP/GLP/GCLP/GVP quality assurance and compliance support. This includes conducting internal and external quality assurance audits to assess compliance with GCP/GLP/GCLP/GVP requirements and guidelines, and ensures implementation of CAPAs to address audit findings; providing analyses and guidance on the interpretation and application of regulations to research and development activities; developing and promoting quality activities/initiatives that enhance Nektar's drug development processes (e.g., departmental SOPs/work instructions); and collaborating with external service providers to help ensure the quality and integrity of services and deliverables. Provides training to functional areas and ensures the content satisfies regulatory requirements and company needs. Support regulatory agency 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 outlicensing or partnering. 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. Works on issues of diverse to complex scope where analysis of situation or data requires evaluation of a variety of factors. Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions. Implements policies when selecting methods, techniques, and evaluation criteria for obtaining results. Assures adherence to budgets, schedule, work plans, and performance requirements.
  • Works on issues where analysis of situations or data requires an in-depth knowledge of organizational objectives, compliance requirements as well as a scientific understanding of the clinical or non-clinical program.
  • Provides drug development teams with clear and fact-based audit results regarding the conduct of clinical or non-clinical studies.
  • Provides guidance to process owners so that effective corrective and preventive actions (CAPAs) are implemented to resolve areas of non-compliance.
  • Develops proactive approaches to implement quality standards, including input to procedures and systems which support compliance requirements for the conduct of clinical studies.
  • Assesses deviations and determines adequacy of reporting and the potential impact on the study.
  • Provides guidance and information on regulations, standards, and quality systems.
  • Interacts with internal senior management and external service providers/CRO senior management on quality matters.
  • Represents Quality Assurance function on various working teams, other functional areas and with external partners. Interacts with other Quality personnel to ensure alignment of quality standards and systems.
  • Keeps current on changes in industry and regulatory standards and requirements and advises on business impact. Participates with other senior managers to establish strategic plans and objectives.
  • GCP/GLP/GCLP/GVP quality systems: Assists in the creation and implementation of Nektar SOPs and other documents to ensure compliance with GxP requirements and Nektar research and development processes. Assists in the development of GxP training programs and may lead training of personnel in functional areas involved in the execution of clinical trials. Responsible for assisting with the management of regulatory agency inspections of clinical studies at Nektar, clinical sites, and service providers. This includes the coordination of follow-up actions and responses to resolve inspection findings. Interacts with Nektar and external service providers/CRO management on quality matters including the preparation of quality agreements. Keeps informed regarding changes in industry and regulatory standards and requirements. Participates in quality improvement initiatives within and outside of Nektar.
  • Auditing: Conducts and manages external audits to assess compliance with GCP/GLP/GCLP/GVP requirements, investigational plans, and Nektar standards for clinical trial-related activities. This includes audits of foreign and domestic clinical investigators, contract clinical laboratories, full-service CROs, and other service providers supporting Nektar-sponsored clinical programs. Plans and conducts internal process/system audits to: 1) assess compliance with regulatory requirements and Nektar standards and 2) ensure and improve quality. Communicates audit findings to audit stakeholders to ensure understanding and collaborates with auditees to develop corrective actions to address root causes.
  • Clinical Development Support: Represents Quality Assurance on various clinical project teams and other working groups, functional areas, and with external partners. Establishes and oversees compliance services for assigned projects including audit activities. Supports due diligence activities including providing responses to prospective partners' quality system and queries. Provides guidance and information on regulations, standards, and quality systems as they apply to research and development programs and studies. Supports clinical sites conducting Nektar-sponsored clinical trials before, during, and after regulatory inspections. Completes compliance activities, tasks, and projects in conjunction with other research and development groups according to established timelines.
  • Other duties as assigned.
Minimum of a Bachelors degree in a scientific discipline is required. Equivalent experience may be accepted. Minimum of 10+ years related experience. Minimum of 8 years experience in the pharmaceutical or other related industry. Minimum of 6 years working experience in a Quality environment with expertise, knowledge, and experience with conducting GCP audits. Minimum of 5+ years of management experience. Comprehensive knowledge of GCP regulations and the ability to interpret and apply GCP standards. Also knowing GLP/GVP regulatory requirements is preferred. Strong verbal and written communication skills, as well as interpersonal and influencing. Ability to thrive in a small group, cross functional setting with limited administrative support. Must be able to develop and maintain collaborative internal and external relationships. Must be goal-oriented and customer-focused to deliver results. 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. Excellent computer skills are 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.