AD, Quality Control

About the role

The Associate Director, Quality Control provides leadership and technical direction by coordinating with others, the activities associated with the testing of viral and bacterial vaccines. This includes all steps of the manufacturing process according to the Regulations or requirements described in the Global Quality Guidance. This role is also responsible for developing a workforce that is quality focused that will maintain compliance and efficient QC processes.

Responsibilities

• Regularly monitors the testing capacities to support the production flows and ensures adequate resources to complete timely testing
• May participate or facilitate problem solving when testing issues disrupt the production flow
• Ensures Quality Control personnel have the proper skills which are demonstrated through defined qualification activities or studies by identifying core skills and tasks related to training requirements
• Participates in the strategy development for new product transfers and equipment purchases in addition to long range planning for future equipment and facility needs
• Participates in building budget for department expense and approve purchases
• Ensures proper use of quality systems by monitoring deviation closure time, change controls, timely completion and thorough OOS investigations, good documentation practices, changes to facility documents, and overall compliance in the department
• Participates in regulatory inspections and global/corporate audits, including management of the most appropriate action plan to address the findings pointed out by the investigators/auditors.

Requirements

• Masters in science related field or combination of a related undergraduate science degree and five to ten (5-10) years of relevant experience
• Seven to ten (7-10) years of experience in biological manufacturing environment with focus in Quality or Analytical Research and Development
• Thorough knowledge of 9 CFR
• Demonstrated technical knowledge
• Experience working with federal regulatory agencies
• Proven leadership skills
• Knowledge of EU GMP

Preferred Eligibility Requirements

• Must be legally authorized to work in the United States without restriction
• Must be willing to take a drug test and post-offer physical (if required)
• Must be 18 years of age or older