Quality Assurance Lead
About The Position
The Quality Assurance Lead will be responsible for leading customer audits independently and supporting the QA Manager for regulatory inspections and agency visits. This role involves drafting audit responses and corrective action plans, monitoring regulation changes, assessing risk, and closing compliance gaps. The Lead will also assist with facilitating scope expansion with regulating/certifying bodies, participate in cross-departmental corrective activities, support quality event trending, and facilitate cross-departmental communication to improve the efficiency and effectiveness of quality processes. Additionally, the role involves preparing Management Review Meeting reports, reporting quality systems status, developing tracking/trending tools, and collaborating with managers on company policies. The Lead will oversee the CAPA system, ensure departmental priorities are met, and approve/reject procedures and specifications. This position also involves resolving client issues, tracking deviations, and advising the Quality Manager on regulatory strategy.
Requirements
- Bachelor's Degree + 7 years QA experience with progressive responsibility OR Master's Degree + 5 years QA experience with progressive responsibility
- Exceptional written/verbal skills for executive reporting and stakeholder engagement
- Deep understanding of requirements and proactive compliance management
- Advanced knowledge of QMS, statistical analysis, and validation
- Expertise in QMS implementation and continuous improvement
- Thorough understanding of ISO 9001, 17025, CFR 210, 211, 820
- Proficient in quality data analysis, trending, and reporting
- Advanced proficiency with QMS software, databases, and statistical tools
- Expert knowledge of GLP, GMP, and regulatory frameworks
- Train and develop QA team on data analysis and quality management
- Strong interpersonal and relationship-building skills
- Oversee large, cross-departmental projects
- Excellent project management and coordination skills
- Advanced problem-solving for complex quality challenges
- Manage multiple high-priority projects simultaneously
- Expertise in root cause analysis and corrective action implementation
- Strong attention to detail with strategic perspective
- Organizational and time management excellence
- Proactively interpret and apply new regulations
- Positive attitude, self-motivated, highly engaged
- Proficiency with Windows, Word, Excel, and specialized quality software
Nice To Haves
- Laboratory/manufacturing quality management experience
- Regulatory inspection representation experience
- Multiple QMS experience (ISO 17025, ISO 9001, GLP, GMP)
Responsibilities
- Lead customer audits independently, and support QA Manager for regulatory inspections & agency visits
- Draft audit responses and corrective action plans
- Monitor regulation changes, assess risk, and close compliance gaps
- Assist with facilitating scope expansion with regulating/certifying bodies
- Participate in cross-departmental corrective activities based on trends
- Support quality event trending and corrective actions
- Facilitate cross-departmental communication
- Improve efficiency and effectiveness of quality processes
- Assist in preparing Management Review Meeting reports
- Report quality systems status to QA Manager
- Develop tracking/trending tools and communicate trends to leadership
- Collaborate with managers on company policies, goals, and procedures
- Oversee CAPA system
- Ensure departmental priorities, goals, and policies are met
- Oversee Quality Assurance Unit policies/procedures
- Approve/reject procedures and specifications for data/client reports
- Review and approve investigations, deviations, and change controls
- Direct inspections and audits for materials, facilities, and test results
- Advise Quality Manager on regulatory strategy and developments
- Resolve client issues to enhance satisfaction
- Lead client audits
- Track deviations, change controls, and complaints
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What This Job Offers
Job Type
Full-time
Career Level
Senior
