This position will develop Calithera’s global GMP quality strategy, ensure compliance to the strategy through training and quality metrics reviews, and direct the Quality Assurance resources needed to execute this strategy.
Duties and Responsibilities
- Develop a Quality Management System that is in full compliance with all regulatory requirements through the translation of the strategy in appropriate procedures.
- Execute the 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 Quality management.
- Direct oversight of all GMP Quality-related aspects for organizations providing contracted services.
- Ensure appropriate systems are in place to support product release in a compliant and timely manner.
- Develop 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.
- Monitor industry trends and regulatory expectations to ensure appropriate evolution of the Quality System and Compliance Strategy.
- 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
- Must have recent hands-on oversight of a GMP 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.
- 15+ years of experience working in the Pharmaceutical/Biopharmaceutical industry (preferably small molecule).
- Bachelor of Science degree in scientific field. MS or PhD desired.
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.
Interested candidates should submit their resume to firstname.lastname@example.org
Local candidates only