Associate Director, Quality Assurance

4 weeks ago

Germantown, Maryland, United States Precigen, Inc Full time
Job Overview

Precigen, Inc. is a biopharmaceutical company dedicated to advancing gene and cell therapies using precision technology. We are seeking a highly motivated and skilled Associate Director, Quality Assurance, to lead the development, implementation, and execution of Quality Systems for our organization.

The successful candidate will manage GxP Compliance activities, work closely with personnel and leaders in product development functional areas, and ensure compliance with applicable regulations, industry standards, and regulatory requirements.

Key Responsibilities

  • Prepare the site for regulatory inspections through quality risk management principles.
  • Manage the site self-inspection program, including developing internal audit plans and leading and participating in audits.
  • Manage inspections by FDA or other regulatory bodies, developing and improving systems for servicing inspections.
  • Facilitate and contribute to the transition of Precigen's Quality System to commercial readiness.
  • Ensure compliance with all regulations, requirements, and industry standards.
  • Act as a champion for Quality within Precigen.
  • Contribute to the reporting of Quality metrics for performance of the Quality System and GxP compliance.
  • Assist in the authorship, review, and/or approval of company policies, procedures, SOPs, and work instruction documents related to GxP.

Requirements

  • Bachelor's degree in Life Sciences or a related field.
  • At least 10 years of QA experience in the pharmaceutical or biotech industry.
  • Experience in development and implementation of commercial Quality Systems is preferred.
  • Strong knowledge of global regulatory and compliance standards.
  • Experience in Quality aspects of preparation efforts for product development.
  • Experience and success in leading a company through pre-approval and post-approval Regulatory inspections is preferred.
  • Knowledge and experience in application of Risk Management principles.

Desired Competencies

  • Exceptional leadership, planning, organization, and execution skills.
  • Ability to understand and execute the company's mission and values.
  • Strong analytical and decision-making skills with attention to detail and quality.
  • Exhibits impeccable confidentiality on sensitive tasks.
  • Ability to anticipate and solve problems while analyzing complex issues and environments.
  • Ability to communicate and work effectively and collaboratively with all levels of employees in various communication mediums.
  • Possess a high degree of personal responsibility.
  • Ability to adapt and succeed in a milestone-driven, rapidly changing product development and commercialization environment.
  • Ability to prioritize and re-prioritize activities as needed to accomplish unanticipated requests or initiate new projects requiring immediate attention.
  • Demonstrates the highest ethical standards and trustworthiness.
  • Strong verbal and written communication and interpersonal skills.

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