Job description
Manager, Quality Assurance and Quality Control
Position Overview:
This role is a key position within the organization, contributing to setting short- and medium-term goals related to quality assurance. The Manager of Quality Assurance & Quality Control is responsible for overseeing and maintaining the company’s quality system and process compliance on a daily basis. This includes monitoring inspection activities, managing non-conforming product dispositions, and ensuring compliance with applicable procedures. The role involves direct interaction with both internal and external customers regarding product release activities as necessary. Additionally, this position plays a key role in coordinating cross-departmental efforts to achieve growth objectives in an entrepreneurial environment. The position is based on-site at the company’s Gaithersburg, MD facility.
Essential Duties & Responsibilities:
- Review and approve relevant document change orders.
- Assist management in developing regulatory strategies for new product or business development.
- Oversee daily activities concerning the quality and safety of tissue products and processes.
- Help establish and implement quality systems and improvements.
- Ensure corrective and preventive actions are taken per established procedures.
- Lead continuous improvement initiatives.
- Monitor regulatory updates from relevant authorities and communicate changes that may impact the company.
Education & Experience:
- BA or BS in life sciences or a related field.
- Minimum of 5 years in a management role with significant quality experience in an FDA-regulated environment, with knowledge of 21 CFR Part 1271, Human Cells, Tissues, and Cellular and Tissue-Based Products (HTC/P) preferred.
- Experience interacting with accreditation agencies (ISO, AATB), and writing required documents in a regulated environment.
- Strong leadership abilities with a proven track record of setting and communicating short-term goals to drive performance.