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:
- 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.
- Deals with conflict in a direct, positive manner.
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