Associate Director, Quality Assurance

Location
San Francisco, CA, United States
Posted
Mar 29, 2021
Ref
5122-420-R
Hotbed
Biotech Bay
Required Education
Other
Position Type
Full time
Position Overview

Nektar has an exciting opportunity for a AD, Quality Assurance to join their team.

The AD, Quality Assurance focuses on the development, implementation and maintenance of quality assurance systems and related activities. This is accomplished through generation and review of documents used in Good Manufacturing Practices as well as regulatory compliance in all areas governed by cGMP regulations (e.g., Production, Packaging, Quality Control, Warehousing, and Distribution). Ensures regulatory compliance is accomplished through audits (internal and external), document review, lead interdepartmental investigations, approval of vendors and facilities. Additionally, the position plays a key role in ensuring operational efficiency through compliant, but not burdensome, quality systems. As a people manager, this position has the responsibility to identify, hire, and develop highly qualified personnel. Finally, this position 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, including an understanding of current business and regulatory trends. 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.
  • Receives assignments in the form of objectives and determines how to tactically meet these goals and manages work priorities to ensure the expedient review and release of drug products.
  • Follows processes and operational policies in selecting methods and techniques for obtaining solutions.
  • Acts as advisor to direct reports to meet schedules and/or resolve technical problems and provides regular performance feedback, development and coaching.
  • Supports quality systems and their maintenance. Acts as management level QA liaison with Manufacturing, Quality Control, senior management and other appropriate organizations.
  • Represents QA to various working teams, other functional areas, and, at times, external partners.
  • Manages and coordinates the activities of projects with responsibility for results with relationship to cost, methods, and employees.
  • Prepares documents for internal and external reports and regulatory filings including contributing to PAI and commercial readiness preparations.
  • Ensures appropriate documentation of activities is developed, implemented, and maintained and determines, evaluates, and investigates deviations from procedure and determines adequacy of reporting and the potential impact on drug products.
  • Provides signatory authorization of final product disposition.
  • Maintains performance metrics and executes on improvement opportunities and supports the implementation of quality improvement initiatives for company operations.
  • Provides Quality guidance manufacturing and laboratory investigations and problem-solving activities.
  • Other duties as assigned.
Minimum of a Bachelor's degree in a scientific discipline is required (equivalent experience may be acceptable). Minimum of 10 years' experience in pharmaceutical/biotech or other related industry. Minimum of 10 years working in a Quality environment. Minimum of 5 years previous management experience preferred. Experience with documentation systems and with document review and auditing responsibilities. Comprehensive knowledge of current Good Manufacturing Practices and the ability to correctly interpret cGMP minimum standards. Working knowledge in quality sciences, statistics, and computer-based operations. Strong verbal and written communication skills. Goal-oriented, quality-conscientious, customer-focused, and detail-oriented. Excellent computer skills. Experience working in a team-focused environment is preferred. Laboratory QC experience is a plus.

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.