Senior Director of Quality Compliance
4 weeks ago
We are a leading manufacturer of hydration solutions, dedicated to elevating the vitality of people and the planet. Our purpose is to make a lasting impact through innovative products and sustainable practices.
Job SummaryWe are seeking a highly experienced Senior Director of Quality Compliance to join our team. This key role will be responsible for ensuring the highest quality products are produced in the safest and most efficient manner, while maintaining compliance with FDA regulations and internal standards.
Key Responsibilities- Lead the development, implementation, and maintenance of quality systems and food safety procedures to achieve company goals and objectives.
- Collaborate with cross-functional teams to resolve key quality issues and develop action plans to address major quality and safety concerns.
- Investigate out-of-specification issues, analyze test data, and identify potential problem areas to prevent issues.
- Develop and implement Liquid I.V. Technology Solutions for Quality Management, including Viva Quality One and Product Lifecycle Management.
- Provide quality and technical support to Product Development teams and ensure compliance with FDA regulations and internal standards.
- Manage certification programs for products, including ISO17025 and GLP, and ensure all documentation and change management requirements are met.
- Lead international programs, collaborate with key stakeholders, and ensure all documentation and change management requirements are met.
- Coordinate and troubleshoot raw material deviations between suppliers, contract manufacturers, and sourcing teams.
- Lead change management programs, ensure documentation is properly routed, managed, disseminated, implemented, and trained on.
- Responsible for raw material and product risk assessments, statistically sound testing protocols, and corrective actions to reverse negative trends in manufacturing-related consumer complaints.
- Develop, monitor, and report on relevant supplier KPIs and scorecards to drive continuous improvements.
- Ensure effective risk mitigation management to reduce risk and interruption in supply and co-manufacturing operations.
- Lead the CAPA management program, ensuring CAPAs are captured, documented, checked for effectiveness, and closed.
- Lead departmental staffing and people development strategies to ensure technical competence, creativity, teamwork, and broad business knowledge.
- Lead internal audit programs to ensure compliance with the Quality System.
- Provide supplemental industry expertise through industry connections and strategic partnerships.
- Bachelor's degree from an accredited college or university in a related field or equivalent combination of education, training, and experience.
- Master's degree from an accredited university in a related field or equivalent combination of education, training, and experience preferred.
- 12+ years of relevant Quality Assurance experience in the food/supplement industry.
- Strong understanding of FDA regulations for Foods FSMA (21 CFR part 117) and Dietary Supplements (21 CFR part 111).
- Working knowledge of plant layout and manufacturing operations to effectively troubleshoot and correct production-related problems.
- Strong working knowledge of GMPs and FDA/ISO guidelines for manufacturing of Food, Supplement products.
- Strong analytical and critical thinking skills.
- Strong attention to detail.
- Strong interpersonal and communication skills.
- Prior experience managing and developing others.
- Ability to represent the company's needs when dealing with suppliers, contract manufacturers, regulatory agencies, and other departments within the corporation.
- 100% company-paid medical, dental, and vision insurance for employees.
- A 401k plan with company match, short and long-term disability coverage.
- A generous PTO and sick policy that includes 13+ paid annual holidays.
- Wellness classes (fitness, mental health, nutrition, finance, etc.).
- An Employee Assistance Program, including membership for guided meditation for all employees.
- Monthly tech and wellness reimbursement.
- An infinite supply of Liquid I.V. for endless hydration.
- Hybrid office environment with flexibility for industry events and up to 40% travel for supplier visits.
Candidates must be authorized to work in the United States without sponsorship.
The expected salary range for this position is $172,200 - $258,400 annually and is bonus eligible.
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