We are seeking a highly motivated and creative individual to join our team as a SENIOR DIRECTOR, QUALITY ASSURANCE. This is an exciting opportunity to be part of a growing, dynamic, and collaborative company focused on delivering cutting-edge technology directly to clinicians for use in diagnostics and disease treatment. The successful candidate will be responsible for the continuous development, execution and administration of the Quality Management System and the corporate quality strategy that meets all compliance requirements as defined by global regulatory authorities and guidance. She/he will serve as the subject matter expert on quality systems, regulatory and compliance requirements
- Develop, execute, and administer Quality Management System (QMS) to cover all aspects of the laboratory services and other corporate activities.
- Establish robust document control system (DCS) and oversees corporate policies and procedures.
- Collaborate with leaders across the organization to ensure policies and procedures are developed and adhered to in support of the QMS .
- Serve as subject matter expert regarding quality and regulatory requirements for the company
- Review validation documentation to ensure compliance with regulatory requirements.
- Review records of internal audits to ensure compliance with regulatory requirements.
- Act as regulatory body liaison for the laboratory.
- Collaborate with the laboratory to design quality and key performance indicators.
- Review all occurrence reports and ensure effective resolution is achieved by the laboratory.
- Monitor and ensures the on-time initiation and closure of Deviations / Investigations, Non-Conformities, CAPAs, Change Controls with thorough & standardized supporting documentation.
- Develop and monitors training programs for technical and laboratory personnel to ensure competence with performance of laboratory activities.
- Perform other duties as required.
- Demonstrates skill at multi-tasking and resourcefulness. Ability to participate simultaneously in multiple projects efficiently
- Demonstrates skill at managing by influence and completing tasks through others in non-reporting relationships.
- Strong analytic & problem-solving ability
- Proficiency with utilization of electronic Document Control Systems (e.g., Master Control)
- Ability to work collaboratively across all functions within the organization
- Excellent written and verbal communication skills are required
- Demonstrated results at both a strategic and hands-on level in managing pre- and post-approval QA relationships
- Responds effectively to inquiries or complaints from customers, regulatory agencies, or internal sources
- BS in Biological Science, Medical Technology, or related field.
- Minimum 10 years Quality Assurance experience
- Minimum of 3 years of supervisory and/or management experience.
- 3-5 years hands-on laboratory experience preferred.
- CLIA/CAP experience required.
- Familiarity with Next Generation Sequencing platforms and workflows preferred.
All interested applicants should send their background and letter of interest to Todd.firstname.lastname@example.org