Senior Director of Quality Assurance
4 weeks ago
The Senior Director of Quality Assurance directs and continually develops, enhances and maintains food safety and quality programs including FSMA, HACCP, SQF, and GMP. They will work with division quality leaders to develop and implement policies and procedures to ensure continued compliance with all regulatory, FSMA, PMO, CFR, SQF Certification, third-party and customer requirements while working with cross departmental operational groups in the development of process improvement and lean manufacturing initiatives.
Key Responsibilities:
- Develop Food Safety Plan by conducting and documenting facility hazard evaluation/analysis, developing and implementing preventive controls, and verifying plan effectiveness against FSMA requirements
- Maintain GMP requirements to current good manufacturing practices (cGMPs)
- Remain current and serve as division SME on all mandated food safety regulations, laws, policies and procedures of the FDA & USDA as mandated by the PMO, CFR & FSMA.
- Ensure that all Shamrock divisions are is audit ready and serve as the co-host of regulatory inspections.
- Serve as multi-facility SQF Practitioner developing and validating SQF program procedures and policies (QA Managers are also required to be SQF practitioners).
- Drives simplification and standardization of audit process and execution across Shamrock Enterprise to ensure compliance with new and emerging regulatory standards and requirements
- Coordinate all regulatory, customer, and third-party audits
- Visit and confer with representatives of ingredient and packaging suppliers to obtain information related to vendor quality standards. Ensure vendor management program includes quality and food safety review for all materials.
- Work with R&D in the development of new product formulations and label compliance review.
- Establish and maintain enterprise quality management systems, policies and procedures that enable Shamrock to comply with regulatory requirements and current regulatory expectations.
- Develop and maintain FSQA training for Shamrock Company. (Set annual training requirements and training frequencies)
- Develop and maintain Shamrock vendor management program and policies, including auditing, performance monitoring and inspection readiness programs.
- Interface directly with division QA leaders to assure cross functional alignment of goals and objectives ensuring compliance and realization systems related best practices.
- Partner with IT/IS to develop and integrate a QMS roadmap that allows for scaling of systems to ensure continued compliance and growth of our business.
- Act as an expert resource and provide expertise, support, and guidance to internal and external partners in resolving complex food safety and product quality challenges and solutions for potential compliance risks.
- Participate in a monthly Quality Management Review meeting (QMR) to review specific set of quality and compliance metrics to state of control and drive targeted actions for continuous improvement.
Requirements:
- Bachelor's degree in Food Science, Microbiology, Chemistry, or related field required. Master's degree preferred.
- 12+ years of experience in food safety & quality assurance
- 3+ years of direct management experience
- Working knowledge of regulatory compliance with USDA, FDA, CFR, PMO and implementing and managing third-party auditing schemes (GFSI, SQF).
- Demonstrated expertise in Dairy, meat, seafood and edible oils manufacturing and processing including UHT manufacturing.
- Ability to review regulatory requirements and evaluate compliance, and experience with regulatory inspections
- 20% plus travel required.
- Must be flexible and willing to work the demands of the department which may be subject to evenings, weekends and holidays.
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