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Senior Manager of Quality and Regulatory

2 weeks ago

Spring Hill, Tennessee, United States Prinova Group Full time $80,000 - $120,000 per year

Prinova is a leading global supplier of ingredients and manufacturing solutions for the food, beverage and nutrition industries. By leveraging our broad in-house array of capabilities as well as years of industry expertise, we support our customers throughout the entire development process, taking their product or formulation idea from concept to completion. As a single-source partner, we strive to provide our customers with the utmost simplicity and flexibility in all their processes.

At Prinova, we pride ourselves on hiring individuals who are innovative thinkers with diverse backgrounds. Our culture is based on the FISH philosophy, which encourages four simple practices: Be There, Play, Make Their Day, and Choose Your Attitude

Senior Manager of Quality and Regulatory

Department: Quality Assurance - Admin

Location: Spring Hill, TN

Job Overview

The Senior Manager of Quality and Regulatory oversees aspects of Prinova Nutrition – TN working with ingredients, flavor applications, vitamins, minerals and other nutrients for sports and lifestyle nutrition. This position will be responsible for defining and advocating a culture of food safety throughout the organization. This includes providing strategic leadership and guidance on the company's quality assurance and food safety programs. This role will implement continuous improvements to enhance quality processes and enforce quality assurance and food safety policies company-wide, while adhering to compliance with regulatory agencies. This role serves as a contact for external auditors, customer audits, and regulatory agencies. This role consults with senior director of quality and operational leadership on the attitudes and practice of food safety and quality throughout the organization to develop an environment of continual improvement in every aspect of the organization's products and services.

Main Duties & Responsibilities

  • Ensures compliance with 21CFR - 110,111,117, 211, FDA (FSMA, FSVP), BRC, Organic, Canada, Halal, Kosher, NSF, NSF-Sport, MSC, Gluten Free, SEDEX, ISO17025, SSCI, customer requirements and other applicable regulations.
  • Ensure food safe production, quality ingredients and regulatory compliance for Prinova Nutrition in a manner that promotes a safe workplace, protects the environment, and exceeds regulatory requirements.
  • This position is responsible for being PCQI trained quality specialist, food safety / food defense leader, HACCP team leader, food safety culture leader and ensure compliance with the Prinova required regulatory agencies and local/state/federal regulations.
  • Ensures in-house manufactured, co-manufactured and 3pls products are produced in compliance with company specifications, policies, and government regulations.
  • Advance strategic plans for improving FSQ systems based on changing needs of the business and the regulatory environment making FSQR excellence a strategic advantage for Prinova.
  • Advance and implement best practices for food safety while driving continuous improvements.
  • Drive the advancement of and compliance with the company's Food Safety Plan including but not limited to evolving content, policies, training.
  • Implement and manage internal FSQR systems and infrastructure to support company growth and provide excellent quality results, as measured by QA metrics (e.g. customer complaint frequency, product evaluation scores and audit scores) and other formal and informal feedback.
  • Ensures effective implementation and/or utilization of approved analytical methods and tools to ensure accurate and timely material testing.
  • Advance FSQR problem-solving and corrective actions ensuring root causes are addressed with appropriate controls and corrective actions that are shared and replicated at all applicable sites.
  • Analyzes, evaluates, and provides recommendations on product quality through oral and written reports.
  • Advance compliance of a proactive quality assurance, food safety and regulatory compliance culture.
  • Advance strategic plans for improving quality related programs including but not limited to sanitation, allergen, HACCP, microbiological testing, EMP, weight control, product recall, company conducted audits, third party audits, customer audits and self-audits.
  • Advance compliance of quality standards/specifications for raw materials, partially finished, and finished products.
  • Advance strategic plans improving the qualification process for new suppliers and manufacturers.
  • Advance compliance food safety audits of suppliers, co-manufacturers, co-packers, and warehouses to ensure Prinova quality standards are maintained and ensure a mutually effective partnership exists.
  • Oversee and lead regulatory and/or 3rd party food safety audits.
  • Support quality assurance system and team that promotes customer satisfaction and that positively impacts financial performance.
  • Advance and support raw material and finished product stability and cost-savings through shelf-life evaluations and rework programs.
  • Advance strategic plans for improving the management of new products or new processes or the installation of new equipment by providing analyses on efficiencies and quality impact and needs.
  • Provide technical guidance on the purchase of raw materials and equipment related to food safety.
  • Provide technical support externally to customer/prospects research and development departments and internally to sales, quality, operations, research and development, and other team members.
  • Oversee the consumer affairs and RMA department ensuring prompt categorization, investigation, resolution, and reporting of consumer comments, complaints, and inquiries.
  • Oversees the completion of customer quality surveys and food safety culture surveys.
  • Oversees regulatory compliance, quality, food safety, risk management and environmental sustainability practices are followed.
  • Perform any additional duties or responsibilities as assigned by the manager, in alignment with the role and organizational needs.

Supervisory Responsibilities

  • Regulatory and Quality Assurance
  • Lead, manage and coach the team;
  • Direct management responsibility;
  • Produce annual My Plans for direct reports, with a focus on developing further management talent and subject matter experts;
  • Conduct regular coaching sessions;
  • Effectively and consistently communicate with quality leaders as well as cross functionally across departments and business unit leaders.
  • The candidate must provide our employees with a safe, positive, and engaging work environment.

Requirements and Skills

  • BS Degree preferably in science; a minimum of 7-10 years of previous FSQR experience preferably with dietary supplements, vitamin/mineral premix, sports and lifestyle nutrition, and contract manufacturing; prefer 5-10 years supervisory experience.
  • Have knowledge of dietary supplements used in the manufacturer of sports and lifestyle nutrition. An advanced degree is a plus.
  • Experience in an analytical / QA laboratory within the dietary supplements, nutraceuticals or pharmaceutical industry preferred;
  • Strong background in core programs 21CFR - 110,111,117, 211, FDA (FSMA, FSVP), BRC/SQF/FSSC, Organic, Canada, Halal, Kosher, NSF and NSF-Sport
  • In-depth understanding needed to apply and evaluate relevant root cause analysis, internal audits, regulatory compliance, food safety legislation and 21 CFR related compliance.
  • Ability to apply principles of logical or scientific thinking to a wide range of intellectual and practical problems;
  • Ability to read, interpret, and create required technical documents;
  • Ability to deal with non-verbal symbols (formulas, scientific equations, graphs, etc.);
  • Ability to direct out of specification (OOS) investigations and review for accuracy;
  • Ability to effectively use computers and other business systems, including Microsoft Office applications including Microsoft Word, Outlook, and Excel;
  • Must be able to work without direct supervision;
  • Ability to lift up to 25 lbs.
  • Ability to sit and stand for extended periods of time;
  • Ability to work around a variety of different smells and aromas;
  • Ability to view a computer screen and type for extended hours;
  • Work environment is normally in an office setting. Must be able to make frequent rounds in a warehouse environment;
  • Other physical requirements include moderate standing and occasional squatting, bending, and twisting;
  • Ability to wear any required PPE;
  • Ability to adjust work schedule as business needs require.

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential

Benefits:

  • Medical, Dental, Vision
  • Employer paid STD and LTD
  • HSA and FSA
  • PTO
  • Employer paid Basic Life Insurance
  • 401(k) & Roth with employer match
  • Eight Paid Holidays + 2 Floating Holidays
  • Voluntary - Critical Illness, Hospital Indemnity, Accident
  • Personal growth including training and development opportunities