Senior Quality Assurance Director

4 days ago

Germantown, Maryland, United States Precigen Full time
Precigen is a pioneering biopharmaceutical company at the forefront of gene and cell therapies. We leverage precision technology to target complex diseases in our core therapeutic areas of immuno-oncology, autoimmune disorders, and infectious diseases.

Our innovative approach to cell and gene therapies has led to the development of novel manufacturing processes for UltraCAR-T and AdenoVerseTM immunotherapies. We are currently evaluating multiple products in the clinic using our cutting-edge manufacturing approach.

We are seeking a highly skilled and motivated Senior Quality Assurance Director to join our Quality Assurance (QA) team. This role will lead the development, implementation, and execution of Quality Systems for Precigen while managing GxP Compliance activities. The incumbent will work closely with personnel and leaders in product development functional areas to ensure compliance with applicable regulations, industry standards, and regulatory requirements.

Key Responsibilities:

* Prepare the site for regulatory inspection through principles of quality risk management.
* 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 Quality System to commercial readiness.
* Ensure compliance with all regulations, requirements, and industry standards.
* Serve as a champion for Quality within Precigen.
* Contribute to the reporting of Quality metrics for the 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.
* Ten (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 the application of Risk Management principles.

Desired Key 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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