Sr Director, GCP Quality Assurance

Summary

Oversees the development, implementation, and maintenance of quality assurance systems and activities that support clinical trial quality, GCP compliance, and program-level quality oversight. Serves as a senior QA partner for assigned clinical development programs, providing independent, risk-based oversight without assuming responsibility for study operations. Directs the generation and review of documentation used in clinical quality systems, trial oversight, and other GCP-regulated activities, and leads internal and external audits involving investigator sites, vendors, and clinical processes. Leads investigations and supports resolution of clinical quality and compliance issues, including protocol deviations, CAPAs, audit findings, and site- or vendor-related concerns, to strengthen quality and operational effectiveness. May select, develop, and evaluate staff to support effective function operations. This role contributes to and supports the company’s research and development efforts to advance therapeutic programs that address unmet medical needs.

Essential Duties and Responsibilities

• Oversees the development, implementation, and maintenance of quality assurance systems and activities for clinical trial quality and GCP compliance.

• Oversees the generation and review of documents used in clinical quality systems, trial oversight, and GCP-regulated activities. Also oversees internal and external audits for GCP activities, including investigator sites, vendors, and clinical processes.

• Leads investigations and supports resolution of clinical quality and compliance issues, including protocol deviations, CAPAs, inspection findings, and vendor- or site-related quality concerns.

• Provides clinical quality expertise and strategic leadership for Phase I–IV clinical development, including trial conduct, inspection readiness, and cross-functional quality support.

• Provides independent, risk-based QA support for assigned clinical programs by reviewing and challenging protocol risk assessments and critical-to-quality assessments; reviewing Sponsor and Vendor Oversight Plans; assessing relevant quality metrics, trends, significant issues, and CAPAs; confirming that vendor oversight and escalation are appropriately documented; and supporting audit follow-up and inspection evidence readiness.

• Provides guidance on regulatory standards, compliance strategies, ICH-GCP, clinical trial regulations, inspection readiness, and clinical quality documentation.

• Represents Quality Assurance on clinical development teams, governance forums, and cross-functional trial teams, as needed, while maintaining appropriate separation from Study Operations responsibilities.

• Leads the implementation of electronic reporting for deviations, CAPAs, audit findings, inspection readiness tracking, and clinical quality metrics.

• Contributes significantly to health authority inspection readiness, sponsor oversight, and clinical trial quality readiness efforts.

Additional Qualifications

• Experience with clinical quality documentation systems, document review, and GCP auditing responsibilities is required.

• Comprehensive knowledge of ICH-GCP, applicable global clinical regulations, and clinical quality standards, and the ability to interpret and apply regulatory requirements effectively, is required.

• Working knowledge of clinical quality systems, quality risk management, data analysis, statistics, and computer-based systems is required.

• Experience providing program-level QA support, including review of protocol risk or critical-to-quality assessments, sponsor or vendor oversight plans, significant quality issues or CAPAs, and inspection-readiness evidence, is preferred.

• Experience supporting clinical audits, investigator site oversight, vendor quality oversight, or inspection readiness activities is preferred. Strong verbal and written communication skills are required.

• Demonstrates sound judgment, a commitment to quality, and a service-oriented approach to cross-functional collaboration.

• Strong knowledge of clinical compliance, data integrity, patient safety obligations, and risk-based quality practices is required. Employees may be required to perform tasks essential to the job function in areas that require the use of hearing protection devices.

• Employees may be required to enroll in a medical surveillance program based on the potential exposure to certain health hazards encountered as a result of their job function. Strong proficiency with electronic quality systems and standard business software applications is required. Demonstrates strong attention to detail and organizational effectiveness.

Education or Degree Requirements

A Bachelors degree in a scientific discipline is required. An advanced degree is preferred. Equivalent experience may be considered.

Minimum Professional Experience

• 15 years of experience in the biotechnology, pharmaceutical, CRO, or related clinical research industry is required.

• 15 years of experience in a quality environment supporting clinical development, with a thorough understanding of ICH-GCP and applicable clinical quality requirements, is required.

• 12 years of progressive people leadership or management experience is preferred.

Physical Requirements

Employees may be required to perform essential job duties in areas where hearing protection is required and to participate in a medical surveillance program based on potential exposure to health hazards associated with their job duties.

Additional Information

Nektar currently anticipates the base salary for the Sr. Director, GCP Quality Assurance to range from $260,000 to $320,000 for candidates in the Bay Area and will depend, in part, on successful candidate's location and qualifications for the role, including education and experience. This position will also be eligible for an annual performance bonus in accordance with the terms of the applicable plan (depending, in part, on company and individual performance and at the Company's discretion on an individual basis.) The compensation described above is subject to change and could be higher or lower than the range described based on the market survey data.

Qualifying employees are eligible to participate in benefit programs such as:

Health Insurance (Medical/Dental/Vision)
Disability Insurance
Holiday Pay
Paid Time Off (PTO)
401(k) Match
Employee Stock Purchase Plan
Wellness Programs
Parental Leave Benefits (in accordance with the terms of applicable plans)
For general information on company benefits, please go to https://www.nektar.com/careers.