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Manager, Quality Compliance

Cellerant Therapeutics, Inc.

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Location: San Carlos, CA, CA Posted Date: 4/17/2013 Position Type: Full time Job Code: SH22013 Required Education: Bachelors Degree Areas of Expertise Desired: Biology
Cell Biology
Quality Assurance

Description

Cellerant Therapeutics, Inc. is a product focused biotechnology company with a portfolio of development stage programs based on the regulation of the hematopoietic (blood-forming) system.  The Company focuses on human stem cell and antibody therapies for oncology applications and blood-related disorders.  Cellerant is developing a novel, cell-based medicine (Myeloid Progenitors) as a treatment for chemotherapy- and radiation-induced neutropenia (CLT-008) as well as for Acute Radiation Syndrome.  The antibody program is focused on discovering novel therapeutic antibodies aimed at cancer stem cells.  Cellerant has been awarded multiple grant/contract awards from the government towards the development of our key programs.

Position Summary:
The Manager of Quality Compliance will provide risk-based quality oversight to the internal and external customers at Cellerant by managing the approved vendor program, and conducting internal and external audits to ensure Cellerant complies with current regulatory compliance trends.  The incumbent will also help develop and maintain a phase-appropriate Quality System, provide companywide training, and lead risk-based initiatives at Cellerant.

Principal Responsibilities:
• Manage and maintain the approved vendor program from selection through qualification of third-party service providers (e.g., contract manufacturers, testing laboratories, contract research organizations, etc.), from a Quality perspective, and ensure expectations for quality and compliance are documented and met.
• Manage and maintain Cellerant’s Quality System.
• Conduct internal and external audits (GMP/GLP) to ensure compliance with Cellerant procedures and regulations.
• Provide support for Manufacturing, Development, Non-clinical and other internal departments to ensure compliance and adherence to Cellerant procedures.
• Lead risk-based initiatives by directing risk assessments at Cellerant.
• Provide companywide training for Quality procedures and compliance based initiatives.
• Assist in hosting regulatory site inspections and coordinating responses to findings.

Requirements

Qualifications:
• At least 8 years of pharmaceutical or biotechnology experience in quality assurance, preferably with both biologics and/or cell based-therapeutics.
• Bachelor of Science or higher degree in a relevant scientific discipline.
• Strong working knowledge of GMP and GLP regulations and industry practices, with a background that includes outsourced contract manufacturing and testing.
• Well-organized and detailed oriented with good verbal and written communication skills.
• Willingness to travel approximately 30% of the time.

Please submit your CV and cover letter to: hr@cellerant.com

Cellerant is an Equal Opportunity Employer, committed to hiring the best qualified individuals and giving them the opportunity to stretch their abilities. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, or national origin. We offer a competitive compensation and benefits package.

Cellerant provides a goal-oriented environment that fosters innovation, professionalism and open communication.  While taking ownership of their specific area of responsibility, employees contribute to the shared goals of a multi-disciplinary team in a dynamic, participative environment.
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