Senior Director of Quality Control

Our client is a well-established organization in the pharmaceutical industry. They are looking for a Senior Director of Quality Control to join their team to oversee various contributing departments to quality control.

Salary/Hourly Rate:

Depending on experience

Position Overview:

The Senior Director of Quality Control will be responsible for the oversight and compliance of departments related to Quality Control. This includes both analytical quality control and microbiology. The Senior Director of Quality Control will also be responsible for strategic oversight in terms of quality for the organization.

Responsibilities of the Senior Director of Quality Control:

• Support management of various departments in terms of operations
• Work with the manager to achieve goals and demonstrate strong, positive leadership
• Resolve technical issues and ensure cGMP compliance relating to quality systems (OOS, CAPA, and Deviations) and data integrity requirements
• Establish, monitor, and improve critical KPIs (Quality Index) in the Microbiology and QC labs related to invalid OOS, analyst error, training, testing plans, release metrics, and stability testing
• Ensure test methods and systems selected have the capability of providing quality results while verification procedures used are adequate to determine the accuracy, precision, and other pertinent characteristics of the method
• Participate, conduct, and/or write OOS and Nonconformance/CAPA investigations and conduct audits of analytical testing documentation
• Support other departments cross-functionally with method validation relating to analytical instrumentation
• Oversee and ensure technical training efforts are provided regarding the education of lab associates regarding cGMP compliance, company requirements as well as other regulatory and sanitation requirements to optimize the function’s responsibilities
• Direct all activities associated with product or facility non-compliance conditions
• Act as the senior site Quality resource regarding decisions associated with the hold or release of non-compliant product
• Other duties assigned as appropriate

Qualifications for the Senior Director of Quality Control:

• ASQ or CQA certification is preferred
• 15+ years of experience in the pharmaceutical industry
• Experience with supporting FDA audits related to QC and Micro labs
• Experience with FDA regulated manufacturing facilities
• Strong management and leadership experience

Education Requirements:

• Bachelor’s degree in a Life Science is required
• Advanced degree is preferred

Benefits:

• Medical
• Dental
• Vision
• 401k with match
• Bonus
• PTO