Manager, Quality Management

The Position:

Quality Manager must have the education, experience and authority to discharge the responsibilities of the position and must have access to personnel at all levels of the laboratory organization as required. The Quality Manager is expected to be a resource person to the Department when there is a need for document review and compliance assessment.

• Essential duties and responsibilities include the following. Other duties may be assigned.
• Responsible for day-to-day oversight of the Quality Management System.
• Monitor the entire quality system to ensure that acceptable levels of performance are maintained.
• Ensure that metrics are established to measure quality and assure that the processes they measure are within established quality standards.
• Provide support for management review of the company’s quality systems and metrics.
• Work with the technical team in ensuring that verification and validation activities are sufficient for the scope of the Clinical Laboratory services offered by the laboratory.
• Review and approve quality records including non-conforming event reports, assay validation reports, corrective and preventive action reports, policies and procedures, software validation reports and documents, deviation reports, etc.
• Facilitate meetings and co-ordinate other personnel as necessary to assure the compliance and quality of the Clinical Laboratory.
• Interact with Government and Regulatory Agencies as appropriate on behalf of the Laboratory.
• Maintain State, Federal and other certifications and licenses as deemed necessary for the operations of the Clinical Laboratory.
• Manage internal audit program, including audit preparation, execution of the audit, the audit report, and follow up to any findings; Be the point of contact for external agencies.
• Monitor Laboratory proficiency testing and personnel training and competency assessments.
• Oversee safety program and training for the laboratory to meet OSHA and other applicable standards; maintain safety permits from federal, State and local agencies as appropriate
• Adhere to department rules and protocols as well as Company policies stated in the Employee handbook.
• Responsible for establishing performance standards, employee coaching and development, determining employee responsibilities, evaluating performance and rewarding as appropriate, disciplining and recommending termination when necessary. Identifies recruits and retains top-notch talent.
• Manage quality personnel and projects to assure compliance with customer and regulatory requirements.
• Completes other duties as assigned.

Who You Are:

• To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skills and/or abilities required. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions
• Bachelor’s or higher degree in a Life Sciences discipline or equivalent
• Seven (7) years relevant experience in a regulated biotech, or pharmaceutical industry with 2-4 years in a quality managerial position performing Quality Assurance functions such as; SOP and protocol writing or review, record and data review, investigations into deviations and out of specification results, training and auditing.
• Knowledge of HIPAA, CFR 21 Part 11, FDA General Principles of Software Validation, 21 CFR 820, CLIA, CAP and, New York requirements.
• Practical experience in auditing practices and procedures.
• Detail oriented and strong written and verbal communication skills.
• Ability to work independently, within prescribed guidelines, or as a team member.
• Must be familiar with Microsoft Office applications.

What We Can Offer You: