Director QC Analytical
Location: Culver City, CA
Direct the design, planning, implementation, and operation control of quality control programs to ensure product reliability, quality, efficacy, compliance to applicable state, federal, and country-specific regulations including cGMPs and internal standards for manufacturing, materials, and finished products related to the COVID 19 vaccine program
- Ensure the complaint (in line with all relevant guidances), efficient operations of Quality Control Analytical by overseeing all laboratory testing (in house and outsourced In Process, Lot Release, and Stability).
- Develop, review and approve methods and documentation including product specifications; protocols, SOPs, reporting of testing, analytical method development and validation, and stability studies.
- Design and implement methods to increase efficiencies and productivity.
- Design and implement methods to improve knowledge of product safety, purity, efficacy, potency, and stability.
- Design and implement strategies to transfer methods into QCA groups
- Ensure QCA decisions align with Quality System, GMP and regulatory requirements.
- Provide budgets for current and future operations including strategy and plans for laboratory relocations and new laboratory implementation.
- Develop the Analytical Quality Control staff to perform at Phase-appropriate levels of compliance.
- Oversee the performance of designated staff.
- Responsibilities include interviewing, hiring, and training employees, planning, assigning, and directing work; appraising performance; rewarding and disciplining employees, addressing complaints, and resolving problems.
- Bachelor’s degree in biology, chemistry, or other science-related fields; equivalent combination of education and experience. Master’s level degree preferred.
- Ten plus years related quality experience (or 8 with a Masters and 6 with a Ph.D.) including a minimum of eight years at the management level with experience in cGMP lab operations within the pharmaceutical industry.
- Extensive experience with assay qualification and validation activities.
- Experience with a start-up pharmaceutical company preferred.
REQUIRED COMPETENCIES - KNOWLEDGE, SKILLS & ABILITIES:
- In-depth knowledge in analytical method development and validation, and statistical quality control.
- In-depth knowledge of GMPs, SOPs, and pharmaceutical regulations.
- Ability to use sound scientific judgment in the management of the facility and processes to prevent regulatory action.
- Understanding of GMPs and an ability to interpret and enforce regulatory requirements.
- Ability to communicate professionally, knowledgeably, and efficiently with a wide range of employees and with all internal and external customers, both in writing and verbally.
- Ability to work with contractors and suppliers, ensuring compliance with company standards and contractor systems.
- Ability to define problems, collect data, establish facts and draw valid conclusions.
- Demonstrated track record in managing staff and establishing a clear, strategic direction.
- Ability to develop leaders, teams, and groups, and appropriately staff the QC department to meet business needs.
- Ability to build morale and group commitments to goals and objectives.
- Ability to analyze and interpret complex, scientific documents.
- Ability to multi-task and prioritize.
- Excellent project management skills.
- Strong problem-solving.
- Strong computer skills
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