Job description

Job Summary
The Quality Systems Manager is responsible for the development, implementation, and ongoing maintenance of policies and procedures that support drug product, medical device, dietary supplement and cosmetic manufacturing, packaging, and distribution systems quality systems in accordance with 21 CFR Parts 111, 210, 211, 700 and 820 (and other applicable regulations and guidance). The Quality Systems Manager is responsible for the administration of quality systems processes, including but not limited to Quality Council/metrics, Training, document control, data governance, Change Control, administration of the deviation program, Corrective and Preventive Actions, Complaints, Recalls, Returns, Annual Product Reviews, the internal audit program, Risk Management, and Regulatory Agency Interactions. Quality Systems, in collaboration with Quality Assurance, has the responsibility for product quality, safety, efficacy, and compliance to cGMP requirements. The Quality Systems Manager works with the Director of Quality and Regulatory Compliance to implement and maintain processes that ensure the verification, monitoring, and effectiveness of the Family Dollar Quality Management System (QMS) and its compliance to applicable regulations and standards.

Principal Duties & Responsibilities

The Quality Systems Manager manages a team of Quality Systems Associates responsible for the Quality System functions within Family Dollar, including but not necessarily limited to: Reviews, approves, and issues controlled documents including Standard Operating Procedures (SOPs), Forms, and other related cGMP related documentation. Oversees the Family Dollar Training program and approves GMP training materials. Assures each department provides SOP, On-The-Job Training (OJT), and GMP training to personnel on a continuing basis. Assures that GMP training files for personnel are stored in a central, accessible, and secure location. Administers and oversees of the discrepancy/deviation and Corrective and Preventive Actions (CAPA) processes, including review and approval of applicable records. Oversees of the regulatory notification process (e.g. market actions such as Medical Device Reports) and monitors and documents product recalls. Administers and oversees the Family Dollar change control system(s). Reviews, documents, and ensures oversight of the commercial product complaint process. Monitors quality metrics for trends, patterns, and recurrences. Administers monthly Quality Council meetings. Monitors the Quality System for compliance with the Quality System Regulation (QSR) requirements. Administers and oversees the Family Dollar Risk Management program. Administers the internal audit program to ensure compliance with Family Dollar policies and control procedures and practices, and regulatory requirements. Notifies Senior Management of inspectional observations and significant quality or compliance issues. Administers and supports the improvement and implementation of Quality Systems. Contributes to process improvement initiatives across the organization; provides support and direction to maintain the quality system to recognized standards; directs and/or participates in the development of QA processes and SOPs. Serves as the Quality Council Coordinator responsible for coordinating and maintaining metrics for review, follows up on action and decision from the Quality Council, takes attendance and prepares the Quality Council Agenda and Summary (meeting minutes) for each meeting. Writes/reviews technical and quality system documents such as SOPs, Change Control and Deviation Reports. Supports, investigates, and troubleshoots problems and develops innovative and effective solutions. Acts as the Quality representative on project teams related to areas of responsibility. Provides continuous training of existing and new-hire quality associate personnel.
Position Requirements

Proficient with Microsoft office applications.
Excellent verbal and written communication skills.
Strong attention to detail.
Works under minimal supervision.
Effective time management and interpersonal skills.
Working knowledge of statistics preferred.

Preferred Qualifications
Bachelor of Science 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 (pharmaceutical or medical device industry preferred). Thorough knowledge of FDA Quality System requirements, 21CFR Parts 111, 210, 211, 700 and 820.
Minimum of 5 years of experience working with CMOs and driving process improvements, or similar.
Minimum of 5 years of experience in a management role preferred.

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