Precision for Medicine
Director, Quality Assurance (Bioservices)
Frederick, MD, USA · Director
Sponsorship not specifiedDetected 5 days ago
Business DevelopmentAuditingProcess ImprovementClinical TrialsFDA RegulatoryMedical DevicesLeadershipMicrosoft Office
About the role
- This position is also responsible for supporting the product quality strategy for Precision for Medicines regulated diagnostic and companion diagnostic product portfolio.
- Essential functions of the job include but are not limited to:
- Plan and direct resources and activities of the quality and compliance functions across all facilities globally
Responsibilities
- Support the quality functions related to FDA QSR, IVDD/IVDR, ISO 13485 and ISO 15189
- Support post-market surveillance activities for in vitro companion diagnostic products
- Ensure participation in project team meetings as a Quality representative and contribute toward development of relevant design control and risk management documentation for commercial diagnostic products
- Host/support external regulatory agency, client and notified body assessments and inspections (example: CLIA, CAP, FDA, ISO, EMA)
- Schedule and manage process and equipment validations and re-validation in accordance with established Standard Operating Procedures
- Maintain robust CAPA, nonconformance, QMS electronic documentation and complaint management systems
- Ability to lead and manage a global quality team
- Experience auditing and interacting and relationship building with the public (regulators, vendors and clients)
- Must possess a valid driver's license allowing you to drive in the state(s) you drive in
Requirements
- Minimum Required:
- Bachelor's degree in physical, Biological Sciences, or technical/scientific field
- 5 years of supervisory experience
- Experience interpreting and complying CLIA, CAP, GLP, GLCP, FDA QSR, ISO15189, ISO 13485, ICH
- Proficiency with common computer applications such as MS Office and other relevant industry computerized systems
- Must be able to read, write, speak fluently and comprehend the English language
- Precision is required by law in some states or cities to include a reasonable estimate of the compensation range for this role.
Compensation
- Precision is required by law in some states or cities to include a reasonable estimate of the compensation range for this role.
Benefits
- Support pre-market activities including design control and risk management of medical devices by authoring and reviewing appropriate documentation.
Company info
- This Director of Quality Assurance (Bioservices) role is responsible for implementing and maintaining the quality systems including organizational resource planning, implementation of technology, and developing and implementing tactical plans to meet Company objectives.
- Provide updates to the company leadership regarding status of the quality system, compliance status and performance relating to quality
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This listing is sourced directly from Precision for Medicine's careers page and normalized into a canonical job model.