Purpose:

The Quality Assurance Manager is responsible for ensuring that all products and services meet established quality standards.

Duties & Responsibilities:

• Maintain a working knowledge of FDA 21 CFR 1271, FDA 21 CFR 820, AATB, other regulations (as appropriate), and industry standards.
• Author, revise, and maintain procedures/controlled documents according to FDA, AATB, and other applicable regulations.
• Manage deviations, nonconformances, complaints, CAPAs, SCARs, and safety incidents and ensure timely completion of associated investigations.
• Ensure adequacy of investigations with respect to root cause analysis and CAPA assessment (as appropriate).
• Establish, evaluate, report, and provide improvements (where appropriate) for quality metrics.
• Manage and oversee review of HCT/P donor records for final product release in accordance with standard operating procedures and regulatory/accrediting agency requirements.
• Manage and oversee review of quality control records to include equipment cleaning, maintenance, environmental monitoring, and supply inspections.
• Assist with training of processes and corrective actions relating to quality.
• Support implementation of new projects/product development.
• Support development of validation/qualification protocols and summary reports in accordance with regulatory requirements and industry best practices.
• Review and approve validation/verification protocols, execution data, and summary reports.
• Support internal, client, and regulatory agency audits to ensure compliance with regulatory requirements, certification requirements, and internal policies and procedures.
• Maintain professional working relationships with customers, partners, and vendors.
• Manage direct reports and monitor individual performance.
• Maintain records in accordance with standard operating procedures.
• Attend/participate in offsite business meetings/conferences.
• Perform other related duties as assigned.

Skills & Abilities:

• Leadership & Management skills
• Attention to detail
• Organized
• Verbal/Written Communication skills
• Analytical Thinking skills
• Technical Writing skills
• Multi-tasking skills

Education & Experience:

• Bachelor’s degree in a biological science or related field required.
• At least 5 years of experience in quality in an FDA regulated environment for HCT/Ps and/or medical devices (or related field), with progressive management responsibility/experience