Director, GMP QA Operations - Permanent - Houston, TX
Lead the charge in GMP excellence-drive quality, compliance, and commercial readiness as Director of QA Operations.
Proclinical is seeking a Director of GMP QA Operations to provide leadership in ensuring GxP compliance and quality oversight of manufacturing operations. This role is pivotal in supporting the transition from early development to late-stage clinical and commercial readiness.
Primary Responsibilities:
The successful candidate will lead a team, oversee quality systems, and collaborate across cross-functional teams to maintain high standards of compliance and operational efficiency.
Skills & Requirements:
- Degree in life sciences, pharmacy, or engineering; advanced degree preferred.
- Comprehensive knowledge of GMP requirements for biologics and aseptic manufacturing.
- Strong understanding of quality systems, risk management, and regulatory expectations for commercial readiness.
- Proven ability to lead teams, manage complex projects, and make sound quality and compliance decisions.
- Excellent communication, problem-solving, and organizational skills.
- Experience in Quality Assurance within the biologics or pharmaceutical industry, including team leadership.
- This role requires onsite presence 3 to 5 days per week.
The Director, GMP QA Operations' responsibilities will be:
- Lead GMP QA Operations and manage the Quality team, including coaching, development, and performance management.
- Ensure compliance with FDA cGMP, ICH, and other regulatory standards.
- Oversee the review and approval of GMP documentation, including SOPs, batch records, protocols, and specifications.
- Manage change controls, deviations, CAPAs, non-conformances, and complaints, ensuring timely and thorough resolution.
- Review and approve manufacturing and QC documentation, validation protocols, and product disposition.
- Conduct internal audits, participate in regulatory inspections, and ensure CAPAs are implemented and verified.
- Manage GMP training programs for personnel involved in manufacturing and quality operations.
- Oversee quality system performance, including KPIs, risk management, and escalation of critical issues.
- Provide oversight of third-party GMP partners and service providers.
- Collaborate with cross-functional teams to ensure high-quality, compliant, and efficient operations.
- Identify and drive continuous improvement opportunities across quality systems and processes
Compensation:
- $190 000.00 - $200 000.00 Per Annum
If you are having difficulty in applying or if you have any questions, please contact Alex Bill at
a.bill@proclinical.com
If you are interested in applying to this exciting opportunity, then please click 'Apply' or to speak to one of our specialists please request a call back at the top of this page.
Proclinical is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Proclinical is acting as an Employment Agency in relation to this vacancy.
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