Quality Assurance Manager

As the Quality Assurance Manager, you will be responsible for clinical quality of laboratory operations. Working closely with the Director, Quality Assurance & Regulatory Affairs, you will provide quality oversight for development and commercial services.

Location: Metropark, NJ, this is a hybrid position requiring 3 days onsite.

What you'll do:

• Guides the implementation, maintenance, and monitoring of processes and procedures to ensure compliance with relevant guidance and requirements.

• Handles document and record control.

• Leads the training programs.

• Supports the tracking, monitoring, and presentation of operational and quality metrics

• Initiates or supports as needed quality improvements initiatives to improve performance and/or mitigate quality or compliance risks.

• Provides guidance in assessing non-compliance events and supports the team effort to define corrective and preventive actions as well as supervising their effectiveness.

• Supports the internal audit program and supplier qualification program

• Assures executive staff is advised of any issues that may adversely impact the Quality System.

• Supports independent monitoring of study conduct to assure management that the facilities, equipment, personnel, methods, practices, records, and controls are in conformance with internal procedures and follow regulations.

• Liaise with external entities such as customers, auditors, and/or regulatory agencies on matters relating to the Quality Management System at the discretion of Quality Assurance Director.

What you'll bring:

• 5+ years of experience in the Healthcare industry (CAP/CLIA/ISO environment) with 2 years of GCP/GCLP-related Quality Assurance experience.

• Bachelors in science, biological science, computational biology, or biotechnology.

• CQA auditor certification is a plus

• Strong organizational and leadership skills to communicate to multi-disciplinary project teams.

• Ability to comprehend regulations and guidance documents and technical information related to equipment, processes, and regulatory expectations.

• The ability to think strategically and maintain an attention to detail.

• Capable of working independently with little supervision and interacting with staff in a fast-paced sometimes pressure filled environment.

• Excellent written and verbal communication skills coupled with strong negotiation and decision-making skills.

• Strong comprehension while applying critical thinking skills to evaluate requirements.

• Ability to present data and defend approaches to inspectors.