What We’re Looking For:
The Director of Quality is responsible for ensuring the highest standards of quality are met across all products and processes. This role involves a hands-on approach to developing, implementing, and maintaining a comprehensive quality system that aligns with regulatory requirements and company objectives.
What You Will Do:
- Lead and direct the QA Manager and quality team in all aspects of quality assurance, quality systems development, regulatory inspections, and daily operations.
- Ensure all procedures are robust, accurate, and aligned with current regulatory requirements.
- Oversee staff recruitment, development, coaching, and performance management in line with HR policies.
- Drive continuous organizational improvement to meet evolving operational goals and compliance demands.
- Represent the company during regulatory inspections (e.g., FDA, Health Canada, CLIA), including preparation, on-site support, and response to inspection reports.
- Provide regular operational and compliance updates to Senior Management, including recommendations and implementation plans.
- Deliver consulting services in QA, QC, regulatory affairs, and operational excellence to new and existing 503B pharmacy compounding facilities.
- Guide facility design, development, and validation with regulatory and GMP alignment.
- Author and deliver training materials in sterile manufacturing, quality systems, and regulatory compliance.
- Perform on-site compliance audits and manage post-audit follow-ups.
- Collaborate with scientific teams to develop a first-class clinical laboratory for genetic sample testing.
- Create and maintain Quality Standard Operating Procedures (SOPs) for:
- Environmental Monitoring
- Defining the Responsibilities of the Quality Unit
- Managing Incidents, Deviations, and Nonconformances
- Conducting Investigations and Corrective and Preventive Actions (CAPA)
- Handling Recalls
- Qualifying Suppliers
- Conducting Vendor Audits
- Conducting Internal Audits
- Performing Annual Product Reviews
- Complaint Handling
- Implement the Quality System, coordinating the commissioning and qualification of the facility, utilities, and equipment.
- Coordinate the execution of Environmental Monitoring Performance Qualification (EMPQ), disinfectant efficacy studies, and cleaning validations.
- Oversee environmental monitoring sample collection
- Oversee raw material monograph and consumables testing.
Who You Are:
- Master’s degree in Regulatory Science or a related discipline.
- Bachelor’s degree in Chemistry, Life Sciences, Microbiology, or a related field.
- Minimum of 5 years of experience in quality management within the pharmaceutical industry.
- At least 3 years of leadership/management experience.
- 15 years of experience in pharmaceutical quality environments.
- 10 years of experience in medical analytical laboratory settings.
- 5 years in technology management.
- In-depth knowledge of 503B regulatory requirements, cGMP, FDA, CLIA, and industry standards.
- Proven experience developing, implementing, and managing quality systems.
- Strong understanding of sampling methods, quality control systems, and analytical method validation.
- Demonstrated ability to lead cross-functional teams and communicate effectively at all levels.
- Proficient in laboratory management software and data trending tools.
- Highly analytical, with excellent organizational and interpersonal skills.
Who We Are
Serving customers since 2004, Eagle offers the highest quality in preparation testing for sterility, bacterial endotoxins, microbial detection, beyond-use dating (BUD) determination and active ingredient potency. State-of-the-art equipment, combined with the experience and knowledge of our team, makes Eagle the best choice for all testing needs. The Eagle team is committed not only to performing the best quality control testing, but also working relentlessly with our customers on solutions if tests receive unexpected results.
Learn more atwww.eagleanalytical.com.
