Manager, Quality Systems

Job DescriptionJob Description

POSITION SUMMARY:

Precigen is a dedicated discovery and clinical stage biopharmaceutical company advancing the next 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 seeking a highly motivated and skilled Manager Quality Systems with automated systems knowledge, strong organizational skills, and keen attention to detail to work with our Quality Assurance team. This position will perform or oversee certain key functions of the Quality Management System – document control, training management, deviation/CAPA management, change control, etc. – in compliance with GxP regulations and company procedures/policies.

DUTIES AND RESPONSIBILITIES:

• Management, maintenance, execution, compliance and continuous improvement of Precigen’s Quality Systems as system owner/facilitator in support of QA operations.
• Business Administrator and SME for Precigen’s EDMS/EQMS.
• Manage all aspects of document control, including but not limited to: administering automated systems and overseeing paper-based processes.
• Prepare Quality Systems performance metrics for management review.
• Support overall QA functions and QA leaders of keys operational areas.
• General “Champion” for Quality and compliance within Precigen.
• Perform additional duties as assigned by supervisor.

EDUCATION AND EXPERIENCE:

• BS/BA degree in a scientific discipline.
• Minimum five (5) years of progressive experience in a pharma/biopharmaceutical QA function.
• Experience with configuring, managing and executing automated document and quality systems; experience with Veeva EDMS/EQMS strongly .
• Knowledge of principles and practices of cGxP.

DESIRED KEY COMPETENCIES:

• Ability to understand and execute on the company’s mission and values.
• Exceptional organization skills with strong attention to detail.
• Strong interpersonal skills including clear communication in both oral and written form.
• Demonstrated ability to work with and coordinate demands from multiple stakeholders.
• Exhibition of the highest degree of ethical standards and trustworthiness.
• Thorough understanding and use of Microsoft Office Suite and Adobe Acrobat Pro.
• Ability to learn then administer automated quality systems.
• Maintain a high degree of ethical standard and trustworthiness.
• Responsive, can-do attitude.
• Deals with conflict in a direct, positive manner.
• Ability to think and adapt to a rapidly changing environment and demands.

WORK ENVIRONMENT:

Administrative office/cubical; some laboratory/cleanroom access

• Frequent: Speaking; hearing; sitting; use of hands/fingers; handling or feeling objects, tools or controls; close vision; vision; peripheral vision; ability to adjust focus.
• Occasional: Standing; walking indoors; reaching with hands and arms; stooping; kneeling; crouching; lifting and/ or move up to 10lbs.
• General: Moderate noise level, similar to typical office environment with computers, printers and light traffic.