Director, Commercial QCA

Position Summary

The Director, Commercial QCA is responsible for the design, planning, implementation, and operation control of quality control programs to ensure product reliability, quality, efficacy, and compliance to applicable state, federal, and country-specific regulations including cGMPs and internal standards for manufacturing, materials and finished products related to the commercial N-803 program and all other QCA programs that are advancing to the commercial stage.

Responsibilities

• Ensure the compliant (in line with all relevant guidance), efficient operations of Quality Control Analytical by overseeing all laboratory testing (in house and outsourced In Process, Lot Release, and Stability).
• Transfer, review, and approve methods and documentation including product specifications; protocols, SOPs, reporting of testing, analytical method development and validation and stability studies.
• Ownership and oversight of all assay trending programs.
• Design and implement methods to increase efficiencies and productivity, and 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 and mentor the Analytical Quality Control staff to perform at a commercial level 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.
• Performs ad-hoc and cross-functional duties and/or projects as assigned to support business needs and provide developmental opportunities.

Requirements

• Bachelor’s degree in biology, chemistry, or other scientific related field with 15 years of related quality experience with 8+ years at the management level required;
• or Master’s degree in biology, chemistry, or other scientific related field with 10 years of related quality experience with 8+ years at the management level required;
• or Ph.D. in biology, chemistry, or other scientific related field with 8+ years of related quality experience with 8+ years at the management level required.

Essential Functions

• Ensure the compliant (in line with all relevant guidance), efficient operations of Quality Control Analytical by overseeing all laboratory testing (in house and outsourced In Process, Lot Release, and Stability).
• Transfer, review, and approve methods and documentation including product specifications; protocols, SOPs, reporting of testing, analytical method development and validation and stability studies.
• Owns and oversees all assay trending programs.
• Designs and implements methods to increase efficiencies and productivity, and to improve knowledge of product safety, purity, efficacy, potency, and stability.
• Designs and implements strategies to transfer methods into QCA groups.
• Ensures QCA decisions align with Quality System, GMP and regulatory requirements.
• Provides budgets for current and future operations including strategy and plans for laboratory relocations and new laboratory implementation.
• Develops and mentors the Analytical Quality Control staff to perform at a commercial level of compliance.
• Oversees 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.
• Performs ad-hoc and cross-functional duties and/or projects as assigned to support business needs and provide developmental opportunities.