Position OverviewThe Quality Assurance Lead Coordinator is responsible for managing and continuously improving the Quality and Safety Management System (QMS), ensuring compliance with Good Manufacturing Practices (GMP) and relevant certifications. This role requires a subject matter expert in GMP standards (EXCiPACT, FSSC22000, BRCGS, etc.), hands-on experience in leading audits, and a strong background in chemical manufacturing processes. The position will lead validation programs, internal and external audits, and drive initiatives to maintain and enhance product safety and quality standards.
Key ResponsibilitiesQuality Management & Compliance - Lead the implementation and maintenance of GMP practices across all operations.
- Ensure compliance with quality and safety standards, including ISO 9001, ISO 22716, ISO 14001, ISO 45001, RSPO, BRCGS, EXCiPACT, FSSC22000, EFfCI, Kosher, and Halal.
- Maintain current certifications and implement new ones aligned with business strategy.
- Develop and deliver training programs on quality standards and GMP requirements.
- Update and control the Document Management System.
Audit Leadership - Develop and manage annual internal and external audit programs.
- Facilitate and lead audits, ensuring compliance with scope, objectives, and timelines.
- Oversee audit execution, review reports, and ensure closure of findings.
- Maintain a qualified audit team and engage external consultants as needed.
- Monitor audit trends and share insights with leadership.
Validation & Risk Management - Manage the execution of the Validation Master Plan.
- Develop validation protocols for equipment, systems, cleaning, and CCPs.
- Ensure compliance with validation programs and revalidation requirements.
- Investigate non-conformities and perform root cause analysis.
Program Development & Continuous Improvement - Lead local Quality & Product Safety Committees.
- Coordinate management reviews, recalls, and non-conformance teams.
- Define KPIs and drive continuous improvement initiatives.
- Implement and train risk analysis methodologies (FMEA & HACCP).
Supplier & Regulatory Management - Qualify and monitor suppliers, supporting supplier audits.
- Manage customer quality documentation and agreements.
- Monitor regulatory developments, including FDA Foreign Supplier Verification Program.
Required Qualifications - Subject Matter Expertise in GMP Standards (EXCiPACT, FSSC22000, BRCGS, etc.) with proven ability to lead GMP programs.
- Hands-on Experience in Facilitating and Leading Audits (internal and external).
- Experience in Chemical Manufacturing Processes with strong understanding of quality and safety requirements.
- Minimum [X] years of experience in quality assurance within chemical or pharmaceutical manufacturing.
- Strong knowledge of ISO standards and risk management methodologies (FMEA, HACCP).
Preferred Skills - Excellent leadership and communication skills.
- Ability to manage multiple projects and priorities.
- Proficiency in document control systems and audit management tools
- Bachelor's degree in Chemistry, Chemical Engineering, Quality Assurance, or related field.
