Summary

This position is responsible for directing activities within the Regulatory Affairs department and throughout the company to ensure continued compliance with all relevant regulatory requirements and food safety standards. This person will be a key leader within the company, setting objectives, goals, and strategies throughout the organization. The incumbent will manage compliance activities relating to regulatory affairs at Amy’s Kitchen on a corporate level with facilities located in Santa Rosa, CA, Medford, OR and Pocatello, ID. The incumbent will work closely with Regulatory Affairs, Food Safety/Quality Systems, and Legal Team in addition to several other departments at Amy’s and various external entities to ensure compliance with regulatory requirements both domestic and international. This position will oversee and help support compliance efforts for third party and customer requirements. Staff members in the Regulatory Affairs Department, including the Certifications Manager, and Policy/Procedures Development Administrator, will report to the Sr. Enterprise Regulatory Compliance Manager.

This position will be a hybrid remote position.

Essential Duties and Responsibilities

• Work closely with management team and lead initiatives to ensure compliance with international (EFSA, CFIA etc.), Federal (FDA, USDA), State and local regulatory requirements throughout the supply chain including sourcing of raw materials, commercialization, production and distribution.
• Oversee regulatory aspects of import and export activities for both finished goods and raw materials and set compliance policies as needed.
• Research new and existing regulatory information related to processing, raw materials, recipes, finished goods, and make recommendations and establish/oversee procedures regarding compliance requirements and strategies for domestic and international
• Interpret and apply regulatory rules, rule changes and customer requirements to determine impact on the company and appropriate Report findings to the leadership group as necessary, make recommendation regarding compliance strategies, and ensure requirements are appropriately communicated through corporate policies.
• Provide input and develop/implement training from a regulatory standpoint to ensure Amy’s procedures, policies and document control systems are compliant and to-date.
• Assist in ensuring timely turnaround and accurate responses to all governmental agency and customer inquiries regarding regulatory, food safety and quality
• Write and/or review responses to regulatory inquiries and requests. Take lead on communicating directly with regulators as appropriate or as needed.
• Support, advise and initiate oversight activities on Corrective Action Preventive Action (CAPA) program corporate-wide to ensure adequacy and timeliness of all responses. Request, review and approve CAPA activities relating to internal, third party or regulatory audits, consumer or customer complaints, internal process/procedural non-conformance, continuous improvement, and raw materials/supply chain issues.
• Actively maintain current knowledge of existing and emerging regulations, guidance documents, hot-button issues, industry standards, regulatory warning letters, and customer requirements. Recommend compliance actions, set standards, and provide guidance on company procedures and policies based on this knowledge.
• Regularly review FDA recalls, FDA warning letters, Import Alerts, and CFSAN Adverse Event Letters. As appropriate, report findings to management throughout the organization, including Senior Leadership, or the Regulatory Bulletin email group and implement corrective measures or process improvement as needed.
• Conduct regular regulatory update meetings with corporate staff and staff at each production location
• Perform regulatory reviews such as the Food Fraud Vulnerability Assessment, Annual Pesticide Testing Assessment, and Corporate Mock Recall. Report findings to leadership and confirm, oversee, or initiate CAPA activities flowing from oversight activities as appropriate.
• Plan and manage activities or projects in response to emerging issues to mitigate and manage risk to the
• Provide regular updates covering recent and relevant regulatory topics and/or emerging issues of significance to Amy’s to the Senior Management
• Lead special projects in RA and QFS to address specific regulatory and food safety and compliance initiatives, aligning with company goals and objectives.
• Serve as a company representative and/or technical liaison with the Amy’s Legal Team, regulatory and professional organizations and appropriate departments within the
• Work closely with outside consultants, laboratories, customers, and regulatory agencies to troubleshoot problems, maintain compliance with internal procedures and regulatory requirements, and continually improve our food safety/quality systems.
• Develop and maintain both formal and informal relationships (networking) with regulatory agencies, consultants, legal entities and customers both domestically and internationally as needed.
• Represent regulatory perspectives within key business functions including but not limited to commercialization, international sales, consumer and customer inquiries, manufacturing, import and export, Quality Systems (HACCP/HARPC), Supplier Quality in order to ensure compliance and best practices.
• Participate in and provide input to sanitary design process for new equipment, production lines, processing areas and facilities. Attend meetings as
• As needed, act as point-person representing RA/QFS in new plant or production line development, working closely with Engineering, Manufacturing and other stakeholder departments on expansion and capacity projects
• Develop and implement new or maintain current compliance programs at the corporate and/or facility level. For example, Intentional Adulteration (IA), food fraud, pesticide testing etc.
• Advise on company-wide software implementations that impact Regulatory Affairs and QFS
• Create essential reports by accessing complex data sets in order to allow for decision making at the Leadership or plant level  
• Assist in developing and managing the budget, allocating resources and planning activities for the Regulatory
• Act as a key member of our recall response team, supporting the Regulatory, Legal, and FSS functions in collecting/reporting information, making key tactical/strategic decisions, providing data and needed reports to customers and regulatory agencies.
• Oversee certifications function (Kosher, Vegan, Biodynamic, Non-GMO, Coeliac etc.) to assure we are in compliance with all product
• Oversee document control procedures to ensure compliance with internal procedural, regulatory and third-party audit requirements
• Support regulatory aspects and customer requirements relating to Sustainability and Social Responsibility as
• Advise and provide guidance and support relating to regulatory, internal, third party, customer, and certification audits
• Provide support for training needs and develop training modules relating to regulatory compliance on topics such as FSMA, organic certification audits, product weight and coding requirements
• Oversee USDA COC compliance activities for milk-containing items shipped to the EU and participate in these audits or training of auditors as needed
• Work to ensure that regulatory compliance remains part of our company culture and central to our continuous improvement effort.
• Lead on or support initiatives called out in in our Objectives, Goals, Strategies, and Measures (OGSM) within the Regulatory Affairs Department and on a corporate-wide level as required.
• Other projects and duties will be assigned as necessary to support our regulatory compliance effort
• It is the responsibility of all employees to uphold the mission of the Amy’s Food Safety and Quality Policy. This includes following all Food Safety and Sustainability programs and participating in all required.

SUPERVISORY RESPONSIBILITIES

This position supervises one or more Food Technologists, Managers, and/or Administrators in the Regulatory Affairs Department.

Qualifications and Skills

KEY FOOD SAFETY PERSONNEL

This position is identified as a key food safety and regulatory compliance role with the authority to initiate actions related to food safety and report food safety problems. In their absence the Senior Director Regulatory Affairs or Organic Program Manager will provide coverage on all shifts.

QUALIFICATIONS

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

EDUCATION

• Minimum BA/BS degree in Food Science and Technology with a concentration in QA/QC and regulatory compliance; or a degree in a related Life Science from a four- year college or university; or an equivalent combination of education and experience.

EXPERIENCE

• Minimum of 7 years of food safety and technical experience with food and food- related products (including food laws and regulations) within a QA/QC
• Minimum of 4 years management experience.

SKILLS

• Excellent communication skills; ability to relate to all internal levels as well as interface with suppliers and government on a technical
• Strong understanding and high skill level with data analysis, Excel, pivot tables, ERP reports and report creation, data manipulation and reporting.
• Ability to distill large amounts of complicated data into concise reports for sharing internally, with third parties and with regulatory agencies as needed.
• Exceptional interpersonal and assertiveness skills necessary to maintain effective and cordial working relationships while being the person whose foremost responsibility is regulatory
• Team player. Works well with food safety staff, local plant management and corporate
• Ability to assess risk and make decisions both collaboratively and independently based on multiple
• Ability to review, assess, distill complex regulatory documents and present with recommendations for decision making
• Detail oriented.
• Reliable/Dependable.

LANGUAGE SKILLS

• Ability to read, analyze, and interpret common scientific and technical journals, financial reports, regulatory, customer, and legal
• Ability to respond to common inquiries from regulatory agencies, customers or members of the business
• Ability to effectively present information to top management, public groups, and/or boards of

MATHEMATICAL SKILLS

• Ability to work with mathematical concepts such as probability and statistical inference, and fundamentals of plane and solid geometry and
• Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical

REASONING ABILITY

• Ability to define problems, collect data, establish facts, and draw valid conclusions.
• Ability to interpret an extensive variety of technical and regulatory instructions in mathematical or diagram form and deal with several abstract and concrete variables.

PREFERRED 

• Project Management experience.
• Knowledge of GFSI (SQF), CI and RCA methods
• SQF Practitioner
• PCQI (Preventive Controls Qualified Individual – Human Foods) Certification
• PCQI Lead Instructor (LI)
• Successful completion of Better Process Control School
• Knowledge of food product
• Membership in IFT, ASQ

COMPETENCIES 

• Team Player – Team oriented; Identify with the larger organizational team and their role within it; Share resources, respond to requests from other parts of the organization, and support larger legitimate organizational agendas as more important than local or personal goals.
• Communicativeness – Recognize the essential value of continuous information exchange and the competitive advantage it brings; actively seek information from a variety of sources and disseminate it in a variety of ways; use modern technologies to access and circulate information, even across great distances; take responsibility for ensuring that their colleagues have the current and accurate information needed for success.
• Initiative – Proactive; Take action without being prompted; Don't wait to be told what to do or when to do it; See a need, take responsibility, and act on it; Make things happen.
• Integrity – Think and act ethically and honestly; apply ethical standards of behavior to daily work activities; take responsibility for their actions and foster a work environment where integrity is rewarded.
• Organizing and Planning – Have strong organizing and planning skills that allow them to be highly productive and efficient; manage their time wisely, and effectively prioritize multiple competing tasks
• Problem Solving and Decision Making – Able to identify problems, solve them, act decisively, and show good judgment; isolate causes from symptoms, and compile information and alternatives to illuminate problems or issues; involve others as appropriate and gather information from a variety of sources; find a balance between studying the problem and solving it; readily commit to action and make decisions that reflect sound judgment.
• Organizational Knowledge – Understand the workings of the organization and the formal and informal policies and structures that govern operations; Know the essential technologies at the heart of the business; Know "how the place works."
• Relationship Building – Understand that a primary factor in success is establishing and maintaining productive relationships; Enjoy interacting with people and are good at it; Devote appropriate time and energy to establishing and maintaining networks. Initiate contacts readily and maintain them over time; Utilize relationships to facilitate business transactions.
• Technical Savvy – Comfortable working around and with new technologies

CERTIFICATES, LICENSES, REGISTRATIONS

• Valid drivers license
• SQF Practitioner and HARPC Qualified Individual preferred.

PHYSICAL DEMANDS

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is frequently required to sit, stay in a stationary position stand; use hands to finger, handle, or feel, talk or hear. The employee is sometimes required to walk, move around an office or plant location, reach with hands and arms, and taste or smell. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision, color vision, depth perception and the ability to adjust focus.

WORK ENVIRONMENT

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

This position is exposed to a work environment where the noise level is moderate; i.e. business office with computers and printers, light traffic, and office conversation.

TRAVEL: Minimal

California Compensation Range: $126,400 - $189,600

*This range is for California employees living in the Bay area. Other locations may be subject to a lower range.