Manager, Quality Assurance

MISSION STATEMENT: Advancing Medicine with Precision

POSITION SUMMARY:

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.

Precigen is seeking a detail-oriented and skilled Quality Assurance Manager/Sr Manager to work with our QA Compliance team. This role will primarily manage/support Precigen's Vendor and Raw Materials Management programs. The position works to ensure compliance with applicable regulations and company procedures/policies.

This will be an onsite role in our Germantown, Maryland facility.

DUTIES AND RESPONSIBILITIES:

• Manage, execute Vendor Management Program including defining qualification plans, performing/coordinating audits, maintaining approved vendor list, etc.
• Facilitate review and approval of Quality Agreements.
• Manage, execute QA aspects of Raw Materials Program including performing/coordinating supplier-material qualifications and completing incoming lot release.
• Manage and report on supplier performance/compliance and corrective actions.
• Assess, define and implement improvements in the Vendor and Raw Materials Management programs and procedures to improve efficiency, accuracy and compliance.
• Promote and ensure Quality and Compliance within Precigen.
• Perform additional QA duties as assigned by supervisor.

EDUCATION AND EXPERIENCE:

• BS/BA degree in a scientific/life sciences discipline.
• Minimum seven (7) years of progressive QA experience in a pharma/biotech environment.
• Knowledge of principles and practices of cGMP, especially vendor/raw materials management.
• Experience in QA support of biologics manufacturing and compliance; experience in Gene Therapy and/or Cell Therapy is a plus.
• Experience in commercial cGMP environment is a plus.

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; experience with Veeva is a plus.

• Responsive, can-do attitude.
• Deals with conflict in a direct, positive manner.

EOE MFDV