Position Summary

The Quality Assurance Manager is responsible for building, implementing, and maintaining quality assurance systems and processes that comply with FDA and GxP requirements. This individual will oversee and execute all aspects of the strategic quality plan across cGxP applications and quality system functions. This role will interface with internal teams, clients, regulators, and other Precision for Medicine facilities.

Essential functions of the job include but are not limited to:

·Collaborate with operational and quality staff in other Precision locations such as Frederick, Maryland, to plan and ensure harmonization of global processes and procedures.

·In conjunction with the QA Senior Leadership, plan and direct resources and activities of the quality and compliance functions. Develop and maintain GxP audit programs for operations.

·Lead inspection readiness activities.

·Host external regulatory agency and notified body assessments and inspections (example: FDA, ISO, CAP). Review and participate in issues and/or decisions related to assessments.

·Manage the Quality System and support the quality functions of all critical operations.

·Create/revise/coordinate controlled document system.

·Review and approve quality system activities (Deviation, CAPA, Audits, Data Review and Disposition).

·Ensure a technical liaison between QA/QS and all other functional management groups in terms of operational objectives, with respect to QA/QS concerns. Ensure that quality assurance and compliance resources are capable of providing required consultation and input for new projects, development activities and technology transfer.

·Contribute to the evaluation and mitigation of program risks and escalation of potentially significant quality issues.

·Participate in cost reduction and improvement programs.

·Serve as the site management representative, providing updates to QA Senior Leadership, QA regarding status of the quality system, compliance status and performance relating to quality.

·Advise staff to help meet established schedules or resolve technical or operational problems.

·Plan, promote and organize training activities related to operations, quality assurance, and compliance.

·Estimate and administer budget schedules and performance standards.

·Maintain an up-to-date knowledge in the techniques of quality and in the company products/services and process technologies.

·Responsible for ensuring management reviews of the quality system are conducted. Maintains up-to-date knowledge of regulations and applicable worldwide standards and requirements.

·Coordinate annual training for Bloodborne Pathogens, Hazard Communication, and Ergonomics.

·Maintain the biological and chemical waste management programs to ensure compliance to Local, State and DOT regulations.

·Schedule and manage the review of computer systems, process and equipment validations and re-validation in accordance with established Company policy. Complete validation protocols and reports, and ensure compliance with all relevant Quality Standards and regulatory requirements.

·Work in conjunction with purchasing department to develop supplier partnership opportunities and ensure supplier qualifications meet current Quality Standards and regulatory requirements.

·Extended business hours may be necessary in order to meet the business demands.

·Travel up to 20%.

Qualifications

Minimum Required:

·Bachelor’s Degree in Physical, Biological Sciences, or technical / scientific field.

Other Required:

·5-8 years of experience as a Quality Professional in the biotechnology or pharmaceutical industry.

·Experience interpreting and complying with world-wide cGxPs with an emphasis on GLP, GLCP, ICH, and CLIA

·Experience auditing and interacting and relationship building with the public (vendors and clients)

·Must be able to read, write, speak fluently and comprehend the English language.

·Proficiency with common computer applications such as MS Office and other relevant industry computerized systems.

Preferred:

·Master’s degree in Physical, Biological Sciences, or technical/scientific field.

·American Society for Quality certification desirable.

·Familiarity with Flow Cytometry and ELISpot applications