Senior Manager, Quality Assurance

Position Summary:

The Senior Manager, Quality Assurance 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:

• Site head of Quality Assurance at the Frederick, MD location of Precision for Medicine
• Lead the team of Quality Assurance specialists
• Quality Assurance representative on the Frederick site leadership team
• Collaborate with operational and quality staff in other Precision locations to execute harmonization plans for global processes and procedures to be implemented and maintained at the Frederick, MD facility
• Plan and direct resources and activities of the quality assurance and compliance functions in conjunction with the Head of Global Quality for Translational Laboratories
• Serve as system owner for a global QMS functions as they pertain to the Frederick site to include process mapping, aligning global practices, promoting improvement, leading and maintaining compliance, and measuring and reporting on performance and effectiveness through established metrics and KPIs
• Host client, external regulatory agency, and notified body assessments and inspections (example: FDA, CAP). Review and participate in issues and/or decisions related to assessments
• Lead inspection readiness activities
• Manage the Quality System and support the quality functions of all critical operations
• Review and approve quality system activities (including but not limited to Deviation, Non-Conformances, Customer Complaints, CAPA, Audits, Validation, Qualification, Equipment, Review and Disposition of final product/data)
• Contribute to the evaluation and mitigation of program risks and escalation of potentially significant quality issues
• Serve as the site management representative, providing updates to the Head of Global Quality for Translational Laboratories 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
• Prepare and lead management reviews of the quality management system for the site and provide inputs to global management review
• Maintains up-to-date knowledge of regulations and applicable worldwide standards and requirements
• Coordinate and/or ensure annual training for HIPPA, Bloodborne Pathogens, Hazard Communication, and Ergonomics, and Quality Compliance
• 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
• Other duties as assigned

Qualifications:

Minimum Required:

• Bachelor’s Degree in Physical, Biological Sciences, or technical/scientific field
• 8 years of experience as a Quality professional in the biotechnology or life science, regulated environment

Other Required:

• Excellent knowledge of medical research processes, laboratory testing protocols, companion diagnostics, and safety requirements
• Strong understanding of medical data collection, record keeping, and reporting requirements
• Experience interpreting and complying with world-wide cGxPs with an emphasis on GMP, GCP, GLP, GCLP, and blood establishments
• Experience auditing and interacting and relationship building with the public (vendors and clients)
• Proficiency with common computer applications such as MS Office and other relevant industry computerized systems
• Extended business hours may be necessary in order to meet the business demands
• This position will require occasional domestic or international travel, including overnight stays (up to 20%)
• Must be able to read, write, speak fluently and comprehend the English language

Preferred:

• Master’s degree in Physical, Biological Sciences, or technical/scientific field
• ASQ or SQA certification desirable (obtain certification within first year)