Precigen, Inc
Associate Director, Quality Assurance
Precigen, Inc, Germantown, Maryland, us, 20875
Precigen is a dedicated discovery and clinical stage biopharmaceutical company advancing the next generation of gene and cell therapies using precision technology to target the most urgent and intractable diseases in our core therapeutic areas of immuno-oncology, autoimmune disorders, and infectious diseases.
Precigen has developed novel manufacturing processes to deliver UltraCAR-T and AdenoVerse immunotherapies to patients. We have multiple products being evaluated in the clinic using our innovative manufacturing approach to cell and gene therapies, and are working toward FDA approval and commercialization of our gene therapy treatment for Recurrent Respiratory Papillomatosis (RRP).
Precigen is seeking a highly motivated and skilled
Associate Director, Quality Assurance
to work with 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 works closely with personnel and leaders in product development functional areas to ensure compliance with applicable regulations, industry standards as well as regulatory requirements and commitments.
DUTIES AND RESPONSIBILITES:
Prepare the site for regulatory inspection through principles of quality risk management.
Responsible for management of the site self-inspection program (develop internal audit plans, lead and participate in audit program, etc.).
Manage inspections by FDA or other regulatory bodies; develop and improve systems for servicing inspections.
Facilitate and contribute to transition of Precigen Quality System to commercial readiness.
Ensure compliance with all regulations, requirements and industry standards.
General “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 as they relate to GxP.
EDUCATION AND EXPERIENCE:
Bachelor’s degree in Life Sciences or 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 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, supporting 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.
EOE MFDV
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Precigen has developed novel manufacturing processes to deliver UltraCAR-T and AdenoVerse immunotherapies to patients. We have multiple products being evaluated in the clinic using our innovative manufacturing approach to cell and gene therapies, and are working toward FDA approval and commercialization of our gene therapy treatment for Recurrent Respiratory Papillomatosis (RRP).
Precigen is seeking a highly motivated and skilled
Associate Director, Quality Assurance
to work with 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 works closely with personnel and leaders in product development functional areas to ensure compliance with applicable regulations, industry standards as well as regulatory requirements and commitments.
DUTIES AND RESPONSIBILITES:
Prepare the site for regulatory inspection through principles of quality risk management.
Responsible for management of the site self-inspection program (develop internal audit plans, lead and participate in audit program, etc.).
Manage inspections by FDA or other regulatory bodies; develop and improve systems for servicing inspections.
Facilitate and contribute to transition of Precigen Quality System to commercial readiness.
Ensure compliance with all regulations, requirements and industry standards.
General “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 as they relate to GxP.
EDUCATION AND EXPERIENCE:
Bachelor’s degree in Life Sciences or 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 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, supporting 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.
EOE MFDV
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