Quality Assurance Principal Specialist
On-siteBaltimore, Maryland, United States
Job Summary
Lead Quality Management System oversight, ensuring compliance with GMP, GLP, GDP, FDA, EMA, and ISO standards while driving audit readiness across assigned sites and business units. Provide independent Quality oversight for deviations, CAPAs, change controls, and customer complaints, leading root cause analyses and risk-based decision-making to mitigate quality risks. Conduct internal audits of facilities, laboratories, and manufacturing operations; manage document control workflows and validate processes to support product release. Analyze quality metrics and trends to present performance data and strategic recommendations to management, fostering a culture of accountability and continuous improvement. Requires 7-10 years in regulated industries; 30% travel.
Required Qualifications
- Bachelor's degree in Biological Sciences, Chemistry, Microbiology, Engineering, Pharmaceutical Sciences, Life Sciences, or a related scientific discipline
- Minimum of 7-10 years of progressive experience in Quality Assurance, Quality Control, Manufacturing, or Operations within pharmaceutical, biotechnology, biologics, cell therapy, medical device, or other regulated industries
- Demonstrated experience managing and improving regulated Quality Management Systems
- Experience with quality investigations, CAPA, deviation management, change control, customer complaints, internal auditing, and regulatory compliance programs
- Working knowledge of GMP, GLP, GDP, FDA, EMA, ISO, and related quality and regulatory requirements
- Strong knowledge of Quality Management Systems (QMS) and quality risk management principles
- Demonstrated expertise in compliance management, inspection readiness, and regulatory expectations
- Advanced proficiency with Microsoft Office applications, including Word, Excel, PowerPoint, and Access
- Experience utilizing electronic Quality Management Systems, document control systems, and quality software platforms
- Excellent analytical skills with the ability to interpret complex quality data and identify meaningful trends and risks
- Strong technical writing skills, including authoring and reviewing procedures, investigations, CAPAs, reports, and audit documentation
- Exceptional verbal, written, presentation, and facilitation skills
- Proven ability to influence cross-functional teams and drive quality-focused decision-making
- Strong organizational skills, attention to detail, and commitment to Good Documentation Practices
- Experience conducting internal audits and supporting regulatory and customer inspections
- Extensive knowledge of manufacturing, laboratory, testing, validation, and quality assurance processes
- Proficiency with MasterControl
Desired Qualifications
- ASQ certifications (CQE, CQA, CMQ/OE) preferred
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