Associate Director of Quality Assurance
germer international pharmaceutical recruitingSan Antonio, TX
Associate Director of Quality Assurance
germer international pharmaceutical recruitingSan Antonio, TXManager L7
Pharmaceutical Preparation ManufacturingResearch and Development in Biotechnology (except Nanobiotechnology)Biological Product (except Diagnostic) Manufacturing
APPLY NOWOur client is hiring an Associate Director or Director of QA. This role will provide leadership, management and responsibility for Quality Assurance Investigations and Operational Auditing functions. Ensures all quality-related corrective measures related to investigations, deviations, change controls, CAPAs, and complaints are conducted, documented, and closed in compliance with FDA, cGMP, and company procedures. Provides strong investigation and report writing skills as a lead author of high criticality Quality Assurance reports and investigations. Oversees quality systems, documentation management, and internal audit coordination to ensure data integrity and continuous improvement within Quality Operations.
REQUIREMENTS:
SKILLS/KNOWLEDGE AND/OR ABILITIESComprehensive understanding of cGMP regulations and FDA expectations for documentation and investigationsDemonstrated expertise in deviation investigations, CAPA management, and root cause analysisStrong investigation and report writing skills with working knowledge of quality systems, change control, and document control processesExperience with audit preparation, management, and follow-up for both internal and regulatory inspectionsExcellent organizational skills and attention to detail in document review and recordkeepingStrong analytical and problem-solving abilities with a data-driven approachAbility to lead cross-functional teams in investigation and CAPA resolution activitiesSkilled in communication with internal teams, regulatory agencies, and external partnersProficiency in use of Quality Management Systems (QMS) and document control softwareAbility to train, coach, and develop personnel in investigation techniques and quality system processesEDUCATION
Required:
Baccalaureate degree in Chemistry, Pharmacy, Biology, or related scientific disciplinePreferred: Advanced certification in Quality Management, Quality Auditing, or related fieldEXPERIENCE10 years experience directly related to pharmaceutical manufacturing and quality assurance operations ideally with at least 5 years of management experience
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Level
Manager L7
Location
San Antonio, TX
Occupation
Quality Control Systems Managers
Industry
Pharmaceutical Preparation Manufacturing
Posted
10 days ago