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 team of Quality Systems Associates responsible for the Company’s Quality System functions. You will be responsible for the development, implementation, and ongoing maintenance of policies, procedures, and processes that support product category, product development, and distribution system quality systems in accordance with applicable regulations and guidance. Quality Systems, in collaboration with Quality Assurance, is responsible for product quality, safety, efficacy, and compliance to cGMP requirements.

Specific responsibilities include but are not limited to:

· Implement and maintain processes that ensure the verification, monitoring, and effectiveness of the Company’s Quality Management System (QMS) and its compliance to applicable regulations and standards.

· Review, approve, and issue controlled documents including Standard Operating Procedures (SOPs), Forms, and other related cGMP related documentation.

· Oversee the Company’s training program and approve GMP training materials.

· Assure each department provides SOP, On-The-Job Training (OJT), and GMP training to personnel on a continuing basis. Assure that GMP training files for personnel are stored in a central, accessible, and secure location.

· Administer and oversee the discrepancy/deviation and Corrective and Preventive Action (CAPA) processes, including review and approval of applicable records.

· Oversee the regulatory notification process (e.g., market actions such as Medical Device Reports) and manage regulatory agency interactions.

· Manage, monitor, and document product recalls and withdrawals.

· Administer and oversee the Company’s change control system(s).

· Review, document, and ensure oversight of product complaint and return processes.

· Monitor quality metrics for trends, patterns, and recurrences.

· Administer regular Quality Council meetings.

· Monitor the Quality System for compliance with the Quality System Regulation (QSR) requirements.

· Administer and oversee risk management program.

· Administer the internal audit program to ensure compliance with regulatory requirements and Company policies, procedures, and practices.

· Notify Senior Management of inspectional observations and significant quality or compliance issues.

· Administer and support the improvement and implementation of Quality Systems, including document control and data governance.

· Contribute to process improvement initiatives across the organization; provide support and direction to maintain the quality system to recognized standards; and direct and/or participate in the development of QA processes and SOPs.

· Serve as the Quality Council Coordinator responsible for coordinating and maintaining metrics for review, follow up on action and decision from the Quality Council, take attendance and prepare the Quality Council Agenda and Summary (meeting minutes) for each meeting.

· Write and review technical and quality system documents such as SOPs, Change Controls and Deviation Reports.

· Support, investigate, and troubleshoot problems and develop innovative and effective solutions.

· Act as the Quality representative on project teams related to areas of responsibility.

· Provide continuous training of existing and new-hire Quality personnel.

Minimum Requirements/Qualifications:

· Bachelor’s degree in technical field, e.g., Chemistry, Microbiology, or Biology, or equivalent.

· Minimum of 7 years of Quality Assurance work experience in FDA-regulated industries.

· Thorough knowledge of FDA Quality System requirements, including 21 CFR Parts 111, 210, 211, 700 and 820.

· Minimum of 5 years of experience working with CMOs and driving process improvements, or similar.

· Excellent verbal and written communication skills.

· Strong attention to detail.

· Works under minimal supervision.

· Effective time management and interpersonal skills.

Preferred Qualifications:

· Minimum of 5 years of experience in a management role.

· Working knowledge of statistics.

· Pharmaceutical or medical device industry experience