Director of QC/QA and Regulatory Affairs
Location: Houston
Posted on: June 23, 2025
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Job Description:
Job Details Description 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 at www.eagleanalytical.com . Qualifications Skills Behaviors :
Motivations : Education Preferred Bachelors or better in Pharmacy
or related field. Masters or better in Biochemistry or related
field. Masters or better in Microbiology and Molecular Cell
Sciences or related field. PHD or better in Biology or related
field. PHD or better in Chemistry. Experience Licenses &
Certifications Equal Opportunity Employer This employer is required
to notify all applicants of their rights pursuant to federal
employment laws. For further information, please review the Know
Your Rights notice from the Department of Labor.
Keywords: , Houston , Director of QC/QA and Regulatory Affairs, Science, Research & Development , Houston, Texas
