Job Description

W2 only-No C2C-We do not provide sponsorship at this time

FDA Reg Compliance Manager

About Us

Based in Chesapeake, VA, Family Dollar operates more than 7,000 stores across the 48 contiguous states, supported by a coast-to-coast logistics network and more than 80,000 Associates. Family Dollar is a leading value retailer serving large and small communities across the country. Come help us grow!

The Opportunity

In this role, you will manage a Food Safety and Quality Specialist and together be responsible for the Company’s FDA regulatory compliance across FDA-regulated products, including private label food products, as well as pet food. You will be responsible for the administration of quality system processes, including but not limited to product disposition, oversight of vendors and foreign suppliers, product and/or purchasing specifications, external audits, significant deviation investigation review, labels/labeling control, warehousing, and distribution. You will also be responsible for the development, implementation, and ongoing maintenance of certain policies, procedures, and processes that support product category, product development, and distribution system quality systems in accordance with applicable regulations and guidance. In collaboration with the broader Product Quality and Regulatory Compliance team, your team will be responsible for FDA-regulated product quality, safety, efficacy, and compliance to cGMP requirements.

Specific responsibilities include but are not limited to:

• Assess vendors, manufacturers, laboratories, and/or materials to confirm their suitability and competence to execute pre-defined activities (e.g., through audits, material evaluations, qualification) in compliance with FDA regulations and guidance, including Good Manufacturing Practices and FSVP requirements under FSMA.
• Approve or reject products through a review of applicable documentation, Certificates of Analysis, Certificates of Compliance, product specifications, and applicable contracted laboratory results.
• Oversee the development and maintenance of product labeling and product purchasing specifications, as applicable.
• Verify that warehouse facilities and stores, as applicable, are following appropriate procedures, including but not limited to appropriate storage conditions, pest control, handling of returns, and waste disposal.
• Verify that transportation companies, as applicable, are following appropriate procedures, including but not limited to appropriate chain-of-custody and transportation conditions.
• Identify and implement actions identified as a result of audits, quality investigations, and deficiencies noted by regulatory agencies such as health authorities.
• Notify management of inspectional observations and significant quality or compliance issues.
• Write and review technical and quality system documents such as SOPs and Deviation Reports.
• Administer and oversee the discrepancy/deviation and CAPA processes, including review and approval of applicable records.
• Oversee the regulatory notification process and manage regulatory agency interactions.
• Manage, monitor, and document product recalls and withdrawals.
• Review, document, and ensure oversight of product complaint and return processes.
• Support, investigate, and troubleshoot problems and develop innovative and effective solutions.
• Act as the FDA Regulatory Compliance representative on project teams related to areas of responsibility.
• Oversee the Company’s training program and approve training materials as relates to FDA regulatory compliance.

Minimum Requirements/Qualifications:

• Bachelor’s degree in technical field, e.g., Chemistry, Microbiology, Biology, Food Science, or equivalent.
• Minimum of 7 years of work experience in FDA-regulated industries, preferably in food.
• Minimum of 5 years of experience in a management role.
• Knowledge of FDA regulatory compliance requirements, including but not limited to 21 CFR Parts 111, 117, 210, 211, 700 and 820.
• Excellent verbal and written communication skills.
• Strong attention to detail.
• Works under minimal supervision.
• Effective time management and interpersonal skills.

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