Quality Assurance (QA) Lead Coordinator
Position Summary
The Quality Assurance (QA) Lead Coordinator is responsible for establishing, implementing, and maintaining the Quality Management System (QMS) to ensure full compliance with regulatory, customer, and internal requirements. This role drives continuous improvement within the Quality and Food Safety System, oversees validation activities, leads product safety initiatives, and manages audits, compliance, supplier oversight, and QMS certification programs. The QA Lead Coordinator ensures that products and processes meet the company's standards while promoting a culture of safety, quality, and regulatory excellence.
Core Role & Authority
Role
- Quality and Safety Management System Manager
- Product Safety Committee Leader
- Leader of Product Safety Committees across all units for validation matters
- Internal Auditor
Authority
- Oversee execution of the Validation Master Plan
- Approve and modify validation plans and programs
- Develop and update validation procedures, protocols, and related documents
- Manage the local Quality Management System
- Lead and ensure Product Safety Management
- Stop any product, service, or activity that jeopardizes product quality, legality, safety, personnel safety, the environment, or facilities
- Determine the appropriateness and effectiveness of corrective actions to close non-conformities
Key Responsibilities
1. Quality Management & Compliance
- Define and monitor KPIs with a continuous improvement focus
- Maintain and control the Document Management System
- Ensure compliance with the Quality and Safety Management System
- Sustain existing certifications and drive corrective actions based on risk and nonconformity analysis
- Implement new certifications aligned with strategic objectives
- Ensure compliance with all applicable standards, including:
ISO 9001, ISO 22716, ISO 14001, ISO 45001, RSPO, BRCGS, EXCiPACT, FSSC22000, EFfCI, Kosher, Halal - Implement GMP practices across QA
- Lead quality initiatives and training programs
- Manage budgets and invoice processes
- Provide QA-related support to cross-functional teams
2. Program & Committee Leadership
- Lead local Quality and Product Safety Committees
- Facilitate management reviews
- Coordinate recall, non-conformance, and food safety teams
- Manage special projects (process mapping, SOP development, 5S implementation)
3. Certifications (FSSC, EXCiPACT & Others)
- Maintain QMS/FSMS to sustain certifications including FSSC 22000, ISO 9001:2015, EFfCI, Kosher, Halal, RSPO
- Develop and implement annual internal and external audit programs
- Serve as Pharma/EXCiPACT specialist and lead pharmaceutical certification initiatives
4. Risk, Validation & Compliance
- Develop validation master plans, cleaning validations, CCP validations, and validation protocols
- Ensure ongoing compliance with all validation plans and assess revalidation needs
- Execute validations per approved protocols
- Investigate system NCRs and conduct root cause and failure analyses
5. Audit Management
- Develop and manage internal and external audit schedules
- Define audit scopes, objectives, and timelines
- Assign and qualify internal/external auditors and consultants
- Oversee audit execution and ensure full compliance
- Review, approve, and issue audit findings and reports
- Track corrective actions through closure
- Provide trend analyses and insights to leadership
- Implement best practices in audit processes
- Conduct internal audits and prepare results reports
6. Tracking, Metrics & Reporting
- Manage tracking and follow-up for all non-conformities
- Lead root cause analysis activities
- Ensure audit findings are fully documented and closed
- Monitor quality metrics and report status to senior management
7. Regulatory & Legal Compliance
- Maintain and implement certifications based on risk assessments and nonconformance trends
- Support legal compliance assessments across all sites
- Monitor Foreign Supplier Verification Program (FSVP – FDA) requirements
8. Supplier Quality Management
- Qualify and monitor suppliers and support supplier audits
- Manage supplier audit and internal audit schedules
- Oversee supplier selection and performance monitoring
- Manage customer-required documentation (questionnaires, quality agreements, contracts, statements)
9. Continuous Improvement
- Define and monitor KPIs aligned with continuous improvement initiatives
- Drive quality and safety system compliance
- Lead quality improvement initiatives and training
- Implement and train teams on risk analysis methods (FMEA, HACCP)
- Benchmark and apply best practices in quality improvement
10. Additional Responsibilities
- Administer the Document Management System
- Conduct quality onboarding for new employees
- Investigate and respond to customer complaints and non-conformances
- Participate in new product introduction (NPI) processes, providing QA review and approval
- Manage department budgets and invoices
- Support QA-related needs at other locations as required
- Perform additional duties assigned by leadership
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