Associate Director, R&D QA
- Employer
- Nektar Therapeutics
- Location
- San Francisco, CA, United States
- Start date
- Nov 12, 2020
View more
- Discipline
- Quality, Quality Assurance
- Required Education
- Bachelors Degree
- Position Type
- Full time
- Hotbed
- Biotech Bay
Job Details
Nektar has an exciting opportunity for an Associate Director 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.
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.
Company
Nektar Therapeutics is a research-based development stage biopharmaceutical company that discovers and develops innovative medicines in areas of high unmet medical need. Our R&D pipeline of new investigational drugs includes treatments for cancer and auto-immune disease. We leverage Nektar's proprietary and proven chemistry platform in the discovery and design of our new drug candidates. Our success is rooted in four key elements: our track record reflected by a portfolio of successful approved medicines which emanated from our chemistry platform and are made available globally by our pharmaceutical partners, our unique research and development pipeline of new investigational medicines in cancer and immunology, our proprietary and proven science and technology approach that fuels our discovery efforts and our team of dedicated scientists, clinicians and employees focused on bringing new medicines to patients with debilitating diseases.
Stock Symbol: NKTR
Stock Exchange: NASDAQ
- Website
- http://www.nektar.com/
- Phone
- 415-482-5300
- Location
-
455 Mission Bay Blvd South
San Francisco
California
94158
United States
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