Element Staffing Services
Senior Quality Assurance Manager
Element Staffing Services, Houston, Texas, United States, 77246
Sr. Quality Manager
Element Staffing is recruiting for a Sr. Quality Manager for a pharmaceutical company in Houston, TX. The Sr. Quality Manager will oversee the site’s Quality Management System (QMS) and Quality Assurance Operations, ensuring compliance with global cGMP requirements, company policies, and applicable regulations.
Responsibilities
Provide site leadership for the Quality Management System (QMS), including eQMS (TrackWise), SAP, and other integrated quality platforms; maintain validated state and ensure data integrity.
Oversee initiation, investigation, approval, and closure of deviations, CAPAs, and change controls in compliance with cGMP requirements.
Maintain robust document-control procedures, issuing, revision, and archival of GMP documentation.
Manage quality oversight of manufacturing, packaging, sampling, and materials release activities to ensure accuracy, lot integrity, and compliance.
Lead the vendor-qualification and supplier management program, including assessments, approvals, and periodic reviews.
Oversee the site-wide GxP training system, ensuring curricula align with regulatory requirements and remain inspection‑ready.
Serve as subject‑matter expert during regulatory and customer inspections; prepare for, host, and manage inspection responses.
Collaborate cross‑functionally with Manufacturing, Validation, Supply Chain, and other departments to resolve quality issues and support production schedules.
Generate, interpret, and report site quality metrics; recommend and implement continuous improvement and operational excellence initiatives.
Prepare, review, and enforce SOPs, ensuring compliance with global regulatory requirements and industry standards.
Develop, coach, and evaluate Quality staff, fostering a culture of accountability, compliance, and continuous learning.
Stay current with regulatory expectations and industry best practices; lead implementation of system and process enhancements.
Qualifications
In‑depth knowledge of FDA, EU, and ICH quality regulations, including 21 CFR Parts 210/211, Part 11, and data integrity requirements.
Strong working knowledge of cGMP, quality systems, validation processes, and applicable pharmacopoeial standards (USP, EP).
Hands‑on experience with eQMS (TrackWise or equivalent), SAP, and other integrated quality/enterprise systems.
Familiarity with vendor qualification, training systems, and operational excellence methodologies.
5‑10+ years of experience in pharmaceutical quality assurance.
BS/MS degree in a Scientific Discipline.
Additional Information
Years of Experience: 5-10+ years
Education: BS/MS degree in Scientific Discipline
Shift/Travel: M‑F, days
Compensation: Base salary + bonus
Assignment Type: Direct Hire
Location: Houston, TX
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Responsibilities
Provide site leadership for the Quality Management System (QMS), including eQMS (TrackWise), SAP, and other integrated quality platforms; maintain validated state and ensure data integrity.
Oversee initiation, investigation, approval, and closure of deviations, CAPAs, and change controls in compliance with cGMP requirements.
Maintain robust document-control procedures, issuing, revision, and archival of GMP documentation.
Manage quality oversight of manufacturing, packaging, sampling, and materials release activities to ensure accuracy, lot integrity, and compliance.
Lead the vendor-qualification and supplier management program, including assessments, approvals, and periodic reviews.
Oversee the site-wide GxP training system, ensuring curricula align with regulatory requirements and remain inspection‑ready.
Serve as subject‑matter expert during regulatory and customer inspections; prepare for, host, and manage inspection responses.
Collaborate cross‑functionally with Manufacturing, Validation, Supply Chain, and other departments to resolve quality issues and support production schedules.
Generate, interpret, and report site quality metrics; recommend and implement continuous improvement and operational excellence initiatives.
Prepare, review, and enforce SOPs, ensuring compliance with global regulatory requirements and industry standards.
Develop, coach, and evaluate Quality staff, fostering a culture of accountability, compliance, and continuous learning.
Stay current with regulatory expectations and industry best practices; lead implementation of system and process enhancements.
Qualifications
In‑depth knowledge of FDA, EU, and ICH quality regulations, including 21 CFR Parts 210/211, Part 11, and data integrity requirements.
Strong working knowledge of cGMP, quality systems, validation processes, and applicable pharmacopoeial standards (USP, EP).
Hands‑on experience with eQMS (TrackWise or equivalent), SAP, and other integrated quality/enterprise systems.
Familiarity with vendor qualification, training systems, and operational excellence methodologies.
5‑10+ years of experience in pharmaceutical quality assurance.
BS/MS degree in a Scientific Discipline.
Additional Information
Years of Experience: 5-10+ years
Education: BS/MS degree in Scientific Discipline
Shift/Travel: M‑F, days
Compensation: Base salary + bonus
Assignment Type: Direct Hire
Location: Houston, TX
#J-18808-Ljbffr