Quality Manager
Job
Kelly Services
Boerne, TX (In Person)
$102,500 Salary, Full-Time
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Job Description
- Quality Manager
Salary Range:
- $90,000 - $115,000
Location:
- Greater San Antonio Area
Industry:
- Pharmaceutical Manufacturing
Work Schedule:
Days- /10 x 4; Monday-Thursday; Off Friday
Benefits:
- Full benefits
- Position Overview
- We are seeking a seasoned
- Quality Manager
- to lead internal quality assurance functions. This role is pivotal in ensuring the integrity of our manufacturing and packaging processes. You will have overall responsibility for batch releases and the execution of critical quality systems, including CAPAs, deviations, and regulatory compliance.
- Key Responsibilities
- + •
Quality Oversight:
- Serve as the Subject Matter Expert (SME) for all quality matters related to manufacturing, packaging, warehousing, and supporting operations. +
Documentation & Release:
- Review and approve GMP Master documents and oversee the final release of all manufactured batches. +
Audit Management:
- Lead the Internal Audit and Supplier Audit Programs; facilitate and host customer audits and support regulatory inspections (FDA and other health authorities). +
Investigations & Compliance:
- Manage change controls, deviations, non-conformances, and customer complaint investigations. Ensure effective CAPAs and conduct effectiveness checks. +
Reporting:
- Coordinate and approve Annual Product Reviews (APRs) and share reports with business partners as required. +
Training & Development:
- Conduct introductory GMP training for new hires and collaborate with senior leadership on continuous improvement projects for existing Quality Systems.
- Qualifications
- + •
Education:
- Bachelor's Degree in a scientific or technical field. +
Experience:
- Minimum of 5 years of related experience in a GMP-regulated environment (Pharmaceutical industry experience is highly preferred). +
Equivalent:
- An equivalent combination of education and professional experience will be considered.
- Technical Skills & Core Competencies
- + Deep understanding of
- FDA regulatory requirements
- and
- GMP standards
- . + Proven track record in managing
- Quality Management Systems (QMS)
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