Associate Director, Quality Assurance
The Development department at Calithera Biosciences is seeking a highly motivated individual to support the development of Calithera’s global GMP quality assurance group and ensure compliance to the GXPs through training and quality metrics reviews.
Calithera is focused on discovering and developing small molecule drugs that slow tumor growth through controlling key metabolic pathways in the tumor and immune cells.
Tumor metabolism and tumor immunology are promising new interrelated fields for cancer drug discovery. Recent clinical successes have demonstrated the potential to slow abnormal cell growth and create fundamentally new therapies for cancer patients. Our investigational onco-metabolism medicines take advantage of the specific metabolic requirements of tumor cells and cancer-fighting immune cells.
Calithera’s discovery and development efforts are focused on diseases for which new treatments are urgently needed for patients suffering from renal cell carcinoma, triple negative breast cancer and other tumor types.
Duties and Responsibilities
- Work with the team to build a Quality Management System that is in full compliant with all regulatory requirements through the translation of the strategy in appropriate procedures.
- Manage the document control program
- Execute internal/external audit and compliance review programs in a manner to confirm full compliance with all regulatory requirements.
- Develop Quality metrics to monitor performance and provide updates to management.
- Oversight of GMP Quality-related aspects for organizations providing contracted services.
- Oversight of GCP Quality-related aspects for vendors, internal GCP-related systems and clinical study sites providing services to the company.
- Ensure appropriate systems are in place to support product release in a compliant and timely manner.
- Assist in developing a Quality Assurance budget and ensure spending is within budget.
- Manage Quality Assurance personnel with a focus on retention and development.
- Oversee QA review and approval of change control requests, OOS/OOT investigations, product and raw material specifications, in-process controls, validation, engineering and quality control protocols, procedures, test plans and summary reports and data integrity audits.
- Ensure effective validation processes for manufacturing, test methods, software, cleaning, and facilities.
- Review and approve compliance documentation including approving regulatory filings for products.
- Responsible for product quality complaints and ensure timely review, investigation, tracking and remedy.
- Oversee the corporate training program ensuring employees are compliant with relevant requirements.
- Assist in developing a culture of quality across the company.
Qualifications and Requirements
- Bachelor of Science degree in scientific field.
- 10+ years of experience working in the Pharmaceutical/Biopharmaceutical industry (preferably small molecule).
- Must have recent hands-on oversight of a GXP environment in compliance with regulatory inspections.
- Must have in-depth knowledge of FDA and EU guidelines and have a proven implementation track record.
- Experienced and fully capable to implement and ensure quality in a GXP-regulated environment.
- Established experience in dealing with regulatory authorities such as the FDA and other regulatory authorities.
- Demonstrated leadership successes in building and creating functions and infrastructure.
- Position requires approximately 35% of travel.
Calithera Biosciences, Inc. is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital and veteran status.