Precigen
Manager, Quality Assurance
Precigen, Germantown, Maryland, us, 20875
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
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