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 assist in completing the day-to-day responsibilities of the Quality Systems Manager for product quality, safety, efficacy, development, and compliance to cGMP requirements. Responsibilities include, but are not limited to, preparing metrics and trending reports, assisting in preparing Quality Council presentations, recording and tracking Complaints and Deviation Investigations, recording and tracking Corrective and Preventive Actions (CAPAs) for Complaints and Deviation Investigations, recording/tracking/writing Change Controls, writing reports, assisting with Medical Device Reports, assisting with recalls, writing and revising Standard Operating Procedures (SOPs), maintaining all master documentation files, recording and maintaining the Company’s Quality training records, and communicating with contract facility management as necessary to ensure the timely completion of required activities.

Specific responsibilities include but are not limited to:

· Write, review, and revise SOPs and forms, as necessary.

· Assist in the review, approval and issuance of controlled documents including SOPs, forms, organizational charts, specifications, and other related cGMP documentation.

· Distribute and notify departments of document releases, changes, and obsolescence of documents and reconcile controlled copies of documents, as applicable.

· Maintain the document archives and conduct periodic reviews of the record retention system.

· Oversee the Company’s Quality training program and approval of GMP training materials.

· Enter the Company’s employee Quality training in the training system, identify overdue training, implements training profile updates, and schedule training as required.

· Maintain and file GMP training records for the Company’s personnel in a central, accessible, and secure location.

· Administer and oversee the internal discrepancy/deviation and CAPA processes within the Company, including review and approval of applicable records.

· Administer and oversee the commercial product complaint process, including oversight of third-party complaint handling administrators, as applicable.

· Communicate with the contract facility/supplier, as warranted, to obtain additional information on Complaints and Deviation Investigations.

· Track closure of Complaint and Deviation Investigations and associated CAPAs generated by contract facility sites as a result of a complaint or event.

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

· Monitor and document product recalls.

· Administer and oversee the Company’s internal change control system(s). Issue Change Control numbers, update electronic tracking logs, route documents for review and approval, and schedule Change Control meetings as required.

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

· Prepare data, metrics, trending reports, and presentations for monthly Quality Council meetings. Monitor the Quality System for compliance with the Quality System Regulation (QSR) requirements.

· Notify the Quality Systems Manager of any trends, patterns, and recurrences.

· Administer and oversee the Company’s Quality risk management program.

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

· Prepare the Annual Product Reviews (APRs) in collaboration with Quality Assurance, suppliers, and other third-parties. Track APRs prepared by contracted facilities to ensure timely submission and review.

· Update and maintain the internal audit schedule and notify the Quality Systems Manager of any overdue audits. Participate in Internal Audits as required.

· Track CAPAs as a result of an Internal Audit observation or action for completion.

· Notify the Quality Systems Manager of overdue CAPAs that are a result of an Internal Audit observation.

· Maintain supplier performance metrics and trend data and communicate data to management and suppliers, as appropriate.

· Notify management of significant quality or compliance issues.

· Assist in other functions, as needed.

Minimum Requirements/Qualifications:

· Ability to work independently guided by documented procedures, with appropriate support.

· Able to work effectively as part of a team.

· Strong attention to detail.

· Excellent verbal and written communication skills with the ability to interact across function, departments, seniority levels and contract facility management.

· Ability to explain problems, develop solutions, and make recommendations, and the ability to handle various urgent requests in a professional manner.

· Effective time management and interpersonal skills.

· Ability to deliver within established timelines.

· Proficient with Microsoft Office applications.

Preferred Qualifications:

· Bachelor of Science degree in a science or engineering discipline.

· Minimum 3 years of Quality work experience in FDA regulated industries (pharmaceutical or medical device industry preferred).

· Working knowledge of FDA Quality Systems (cGMP) and regulatory requirements (e.g., 21 CFR Parts 111, 210, 211, 700 and 820).

· Working knowledge of statistics.