Sr. Manager, GCP GLP IT QA

San Francisco, CA, United States
Aug 13, 2019
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time
Position Overview

This job contributes to and supports the company's R & D goal of creating high value therapeutics by providing drug development programs with strategic GCP/GLP/GCLP/GVP quality assurance and compliance support, with focus on IT QA activities.

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 cogent analyses and guidance on the interpretation and application of GCP/GLP GCLP/GVP regulations to research and development activities; developing and promoting GCP/GLP/GCLP/GVP quality activities/initiatives that enhance Nektar's drug development processes (eg. Departmental SOPs/ Work Instructions); and collaborating with external service providers to help ensure the quality and integrity of services and deliverables. Provides GCP/GLP/GCLP/GVP training to functional areas and ensures the content satisfies regulatory requirements and company needs. Support regulatory agency GCP/GLP/GCLP/GVP 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. 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/clinical 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 preventative 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 GCP/GLP/GCLP/GVP deviations and determines adequacy of reporting and the potential impact on the study. Provides guidance and information on GCP/GLP/GCLP/GVP regulations, standards, and quality systems. Interacts with internal senior management and external service providers/CRO's senior management on GCP/GLP/GCLP/GVP quality matters. Represents GCP/GLP/GCLP/GVP 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/GLP/GCLP/GVP requirements and advises on business impact. Participates with other senior managers to establish strategic plans and objectives. This position works with the compliance administrator to: a) complete all recurring compliance tasks, b) ensure all computer systems are evaluated, selected, implemented and maintained in compliance with the applicable regulations (GLP, GCP, GVP) or IT SOPs that apply to those systems, and c) develop (or revise) those documents required to complete system validation, implementation projects, and management of change control as defined by Nektar QA or GCP/GLP Compliance. Responsible for the revision and maintenance of applicable Nektar CSV and other IT SOPs as required. Works on issues where analysis of situations or data requires an in-depth knowledge of organizational objectives as well as an understanding of the business. Reviews and signs off on those recurring documents that demonstrate Nektar's compliance with applicable regulations. Develops, analyses, revises and approves Validation Plans, Installation Qualification, Operational Qualification, Production Qualification, Validation Summary Reports, and other validation documentation from GXP QA perspective as required. Develops, analyses, revises and approves system test scripts for nonvalidated systems based on the system requirements as defined by the assigned IT Project Manager and Business Partner. Leads or contributes to Supplier Audits and IT Services Quality Agreements in conjunction with Nektar QA and GCP/GLP Compliance departments to ensure compliant supplier management. Participates in internal audits and external Health Agency inspections of Nektar computerized GxP systems. Works with the GCP/GLP Compliance and QA departments to identify gaps (if any), review validation processes and procedures and implements changes and/or improvements to meet appropriate regulatory requirements, internal policies and current industry practices. Participates in SOX audits and control reviews. Other duties as required.

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 3 years of supporting IT QA activities such as change control and computer system validation. 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. 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.