Quality Assurance Manager (remote eligible)

Quality Assurance Manager
Job Summary

The Quality Assurance 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 in accordance with 21 CFR Parts 111, 210, 211, 700 and 820 (and other applicable regulations and guidance). The Quality Assurance Manager is responsible for the administration of quality system processes, including but not limited to product disposition, batch review, oversight of contracted facilities, quality agreements, product and/or purchasing specifications, external audits, significant deviation Investigation review, labels/labeling control, warehousing, and distribution. Quality Assurance has the responsibility for product quality, safety, efficacy, and compliance to cGMP requirements. The Quality Assurance Manager works with the Director of Quality and Regulatory Compliance to implement and maintain processes to assure control and quality of outsourced activities.

Principal Duties & Responsibilities
The Quality Assurance Manager manages a team of Quality Assurance Associates responsible for the Quality Assurance functions within Dollar Tree including, but not necessarily limited to:

• Assesses current and proposed contract manufacturers, laboratories, and/or materials to confirm their suitability and competence to execute the pre-defined activities (e.g., through audits, material evaluations, qualification) in compliance with Good Manufacturing Practices.
• Establishes requirements and scheduling for periodic external audits. Provides oversight of third parties that may perform external audits on behalf of Dollar Tree.
• Establishes and maintains Quality Agreements with supply partners.
• Assures that appropriate process validation studies are conducted, stability studies are conducted, and retain samples are maintained to support Dollar Tree private-label products.
• Approves or rejects products through a review of applicable documentation, Certificates of Analysis, Certificates of Compliance, product specifications, and applicable contracted laboratory results. Nonconformances may be reviewed as specified in the Quality Agreements with supply partners.
• Oversees the development and maintenance of product labeling (including primary package labeling, printed containers, and product informational inserts) and product purchasing specifications as defined in the executed Quality Agreements.
• Verifies that appropriate procedures are being followed by transportation companies, including but not limited to appropriate chain-of-custody and transportation conditions.
• Verifies that appropriate procedures are being followed by warehouse facilities, including but not limited to appropriate storage conditions, pest control, handling of returns, and waste disposal.
• Identifies and implements actions identified as a result of audits, quality investigations, deficiencies noted by health authorities, etc.
• Notifies Senior Management of inspectional observations and significant quality or compliance issues.
• Identifies opportunities for improvement within existing quality systems and implements effective changes.
• 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.
• Reviews and approves technology transfers to or between contracted facility sites, if applicable.
• 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.

Preferred Qualifications

• Bachelor of Science degree in technical field, e.g., Chemistry, Microbiology, or Biology.
• 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 Contract Manufacturing Organizations and driving process improvements.
• Minimum of 5 years of experience in a management role preferred.