Senior Manager Regulatory & Process Validation Compliance in Edina MN

Senior Manager Regulatory & Process Validation Compliance
Job ID: 
Edina MN
Not Specified
Not Specified
Job Types:
QA/Lab Manager, Regulatory Affairs/Compliance





SunOpta Overview:

SunOpta Inc. is a leader in the plant-based foods and beverages, fruit-based foods and beverages, and organic ingredient sourcing industries. SunOpta is focused on sustainability and specializes in the sourcing, processing, and packaging of organic, conventional, non-GMO food products.

SunOpta is looking for talented individuals that demonstrate our most valued behaviors: Passion, Dedication, Speed, Entrepreneurship, Customer-Centricity, and Problem-Solver, to help create a brighter, healthier, and sustainable future of food!

Job Summary:

This position provides expert support and guidance for ensuring regulatory and company policy compliance for product and processing system design, maintenance, and operation. Responsibilities include ensuring established preventive control in all aspects of product and process design are followed, establishing minimum system documentation requirement, and establishing minimum system critical limit requirements. Focus will be on FSMA (21 CFR 117), and 21 CFR 113/114 compliance, plant aseptic and extraction systems, legacy HACCP programs including LACF and Acid/Acidified programs, and USDA 9 CFR Part 431. The position will support all platforms in fulfilling Food Safety and Quality Excellence in the plant-based food and beverage division for SunOpta.

Essential Functions of the Job:

  • Proactively partner with the R&D and Engineering to evaluate, develop, and commercialize new processing technologies.
  • Oversee thermal process validation for new and existing products and provide direction for product disposition based on microbiological results. Partner with project teams on writing user requirement, design requirement and validation protocol.
  • Set the strategy for thermal process/food safety testing for facilities, co-manufacturers, and corporate.
  • Partner with R&D (and vendors) in development of preservation processes based on scientific principles to optimally produce safe and high-quality products. Provide process instructions to preserve/process products manufactured by the company.
  • Provide leadership in food safety programs and standards to assure that manufacturing processes and environments are microbiologically safe for producing both new and existing products.
  • Act as a troubleshooting resource to investigate and correct thermal process/food safety non-conformities at plants and contract manufacturers.
  • Provide recommendations regarding process design, product disposition, and continuous improvement.
  • Manage/supervise/audit all original process development files, process deviation files, and regulatory process filing files for regulatory compliance.
  • Support food safety risk assessments for new/existing processing lines.
  • Oversee registration of all necessary sterilization information with FDA for all facilities.
  • Provide necessary direction for all process deviations correction at factories.
  • Conduct GMP and HACCP-based audits in a variety of food processing and related environments.
  • Heavily engage in fully understanding Food Safety Modernization Act regulation; Aid in the development/implementation, & long-term oversight of FSMA, by means of conducting gap analyses/risk assessments/policy development throughout the network and partnering with functional team leaders to ensure there is FSMA execution network wide.
  • Responsible for facilitating verification program development network wide, with appropriate team leadership.
  • Facilitate compliance to Federal regulation by compliance dates published by FDA.
  • Collaborates on the review of facility, co-packer and supplier validations.
  • Responsible for facilitating verification program development network wide, with appropriate team leadership.
  • Ensure timeliness, consistency, and accuracy in all audits and audit reports.
  • Work within existing ISO 17065 certified audit platform, adhering to all official procedures.
  • Represent SunOpta with outside consultants, trade associations, and appropriate industry groups.
  • All other duties as assigned.

Supervisory Responsibilities:


Minimum Qualifications:

  • Master&##39;s Degree in Food Science / Microbiology / or Engineering
  • PHD is a plus.
  • 5-7+ years of experience in/with food manufacturing environments with emphasis on program development and implementation.
  • Must also have experience with IQ/OQ/PQ validation.
  • Thermal process experience required, aseptic experience a plus.

Knowledge and Skills:

  • Candidate must possess a strong working knowledge of food safety, HACCP, GMP&##39;s, FSMA, sanitary design and controls, food regulations and basic food technology.
  • Knowledge of Lean Manufacturing practices is beneficial.
  • Outstanding verbal, written, multi-tasking and presentation skills.
  • Ability to create momentum and foster organizational change.
  • Bilingual in Spanish is beneficial.
  • Must have a working knowledge of MS Word and MS PowerPoint software, and be proficient with MS Excel software.
  • Experience with Oracle is beneficial.
  • Candidate must be able to maintain confidentiality and impartiality in all aspects of work and adhere to all procedures established.
  • Exhibits professional behavior appropriate to a food safety auditor, behaving with integrity, honesty, impartiality, and reporting any potential conflicts of interest.
  • Ability to maintain applicable professional development and training qualifications required for audit proficiency.

Travel Requirements:

Travel Expectation: 30-40%

Work Environment/Physical Demands:

Approximately; 60% of the work is performed in an office environment. 40% of work may involve being in the agricultural or manufacturing environment)

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time, with or without notice.



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