Senior Manager, Quality Assurance

Precision For Medicine
Frederick, MD
Dec 05, 2022
Dec 08, 2022
Full Time
A$ A' "A' ?Position SummaryThe 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 MedicineLead the team of Quality Assurance specialistsQuality Assurance representative on the Frederick site leadership teamCollaborate 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 facilityPlan and direct resources and activities of the quality assurance and compliance functions in conjunction with the Head of Global Quality for Translational LaboratoriesServe 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 KPIsHost client, external regulatory agency, and notified body assessments and inspections (example: FDA, CAP). Review and participate in issues and/or decisions related to assessmentsLead inspection readiness activitiesManage the Quality System and support the quality functions of all critical operationsReview 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 issuesServe 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 qualityAdvise staff to help meet established schedules or resolve technical or operational problemsPlan, promote and organize training activities related to operations, quality assurance, and complianceEstimate and administer budget schedules and performance standardsMaintain an up-to-date knowledge in the techniques of quality and in the company products/services and process technologiesPrepare and lead management reviews of the quality management system for the site and provide inputs to global management reviewMaintains up-to-date knowledge of regulations and applicable worldwide standards and requirementsCoordinate and/or ensure annual training for HIPPA, Bloodborne Pathogens, Hazard Communication, and Ergonomics, and Quality ComplianceMaintain the biological and chemical waste management programs to ensure compliance to Local, State and DOT regulationsSchedule 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 requirementsWork in conjunction with purchasing department to develop supplier partnership opportunities and ensure supplier qualifications meet current Quality Standards and regulatory requirementsOther duties as assignedMinimum RequiredQualifications:Bachelor's Degree in Physical, Biological Sciences, or technical/scientific field8 years of experience as a Quality professional in the biotechnology or life science, regulated environmentOther RequiredExcellent knowledge of medical research processes, laboratory testing protocols, companion diagnostics, and safety requirementsStrong understanding of medical data collection, record keeping, and reporting requirementsExperience interpreting and complying with world-wide cGxPs with an emphasis on GMP, GCP, GLP, GCLP, and blood establishmentsExperience 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 systemsExtended business hours may be necessary in order to meet the business demandsThis 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 languagePreferredMaster's degree in Physical, Biological Sciences, or technical/scientific fieldASQ or SQA certification desirable (obtain certification within first year)Any data provided as a part of this application will be stored in accordance with our Privacy Policy .Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law. A' (C) 2020 Precision Medicine Group, LLCIf you are an individual with a disability and require a reasonable accommodation to complete any part of the application process, or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at QuestionForHR@ .

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