Sr. Manager, Quality - Regulatory Affairs

Kraft HeinzPittsburgh, PA
7d

About The Position

Senior Manager, Regulatory Affairs This role serves as the lead for Operational Food Safety &/or Food Safety-related Regulatory Affairs (FDA) for several Operational Business Units (BUs) in the US Zone. This individual provides organizational leadership across several key operational support areas, while providing regulatory food safety-related expertise to key business partners to ensure consumer safety and brand sustainability. Key Components of the Role The position provides organizational leadership and food safety regulatory affairs support to internal/external manufacturing sites that make products that are regulated by the US FDA and CFIA. Lead and develop training for factories, cross functional teams and team members for their respective BUs concerning regulatory issues. Provide leadership support for several BUs that include factories regulated by US FDA and CFIA, while coaching and directing the respective Factory Quality Managers and BU Corporate Quality. Managing relationships with key regulatory agencies (FDA and CFIA), resolving escalations and partnering with KHC Legal and KHC Government Affairs to influence relevant legislation. Review, track and trend factory inspections and nonconformances to ensure corrective action sharing across the network. Monitor significant issues across industry and apply learnings internally. Provide input on HACCP policy development and conduct training and support with factories. Provides FDA regulatory expertise for Special Situations in the US zones. Acts as a point of contact for FDA Food Safety matters, partnering with Corporate Food Safety leads, Corporate Quality, and Regulatory Labelling to manage issues. Act as liaison for industry trade groups as assigned. Provide support for other programs, including National Organic Program compliance and Prop 12, and assist with US FSIS and CFIA matters as needed.

Requirements

  • Master of Science degree preferred, focused on Food Safety or Food Microbiology.
  • 7 plus years of experience in food safety and/or regulatory affairs.
  • Ability to troubleshoot food safety issues by observing, analyzing data and identifying gaps and corrective actions, including influence of product formulations on thermal process efficacy.
  • Idea leadership, change management, able to influence the business, able to manage conflict and drive the Quality Management agenda.
  • Ability to communicate upward effectively, conduct training, and collaborate with cross-functional groups.
  • Ability to develop justification and communicate to business partners when unplanned corrective actions, including capital expenses, are necessary.
  • Ability to lead people, providing timely feedback to address and optimize personnel performance, while facilitating performance and career development for their direct report.
  • Significant understanding of quality systems/processes (ISO, Six Sigma etc.)
  • Excellent communication skills (presentation, report writing, teaching/training).
  • Work experience in team-oriented functions as well as individual contribution.
  • Action-oriented with good project management skills.
  • Travel requirements up to 15% a year.

Responsibilities

  • Provide organizational leadership and food safety regulatory affairs support to internal/external manufacturing sites that make products that are regulated by the US FDA and CFIA.
  • Lead and develop training for factories, cross functional teams and team members for their respective BUs concerning regulatory issues.
  • Provide leadership support for several BUs that include factories regulated by US FDA and CFIA, while coaching and directing the respective Factory Quality Managers and BU Corporate Quality.
  • Managing relationships with key regulatory agencies (FDA and CFIA), resolving escalations and partnering with KHC Legal and KHC Government Affairs to influence relevant legislation.
  • Review, track and trend factory inspections and nonconformances to ensure corrective action sharing across the network.
  • Monitor significant issues across industry and apply learnings internally.
  • Provide input on HACCP policy development and conduct training and support with factories.
  • Provides FDA regulatory expertise for Special Situations in the US zones.
  • Acts as a point of contact for FDA Food Safety matters, partnering with Corporate Food Safety leads, Corporate Quality, and Regulatory Labelling to manage issues.
  • Act as liaison for industry trade groups as assigned.
  • Provide support for other programs, including National Organic Program compliance and Prop 12, and assist with US FSIS and CFIA matters as needed.

Benefits

  • Coverage for employees (and their eligible dependents) through affordable access to healthcare, protection, and saving for the future, we offer plans tailored to meet you and your family’s needs.
  • Coverage for benefits will be in accordance with the terms and conditions of the applicable plans and associated governing plan documents.
  • We offer events, resources, and learning opportunities that inspire a physical, social, emotional, and financial well-being lifestyle for our employees and their families.
  • You’ll be able to participate in a variety of benefits and wellbeing programs that may vary by role, country, region, union status, and other employment status factors, for example: Physical - Medical, Prescription Drug, Dental, Vision, Screenings/Assessments Social - Paid Time Off, Company Holidays, Leave of Absence, Flexible Work Arrangements, Recognition, Training Emotional – Employee Assistance Program , Wellbeing Programs, Family Support Programs Financial – 401k, Life, Accidental Death & Dismemberment, Disability
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