Address
Form of work
SalaryPurpose:
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
