Senior Director, Infrastructure Services
Flexential
AWSAzureCloudCyber SecurityVMware
Director, Quality Audits
GRAIL
full-time
Posted on:
Location Type: Hybrid
Location: Durham • North Carolina • 🇺🇸 United States
Visit company websiteSalary
💰 $167,000 - $239,000 per year
Job Level
Lead
About the role
- Interface with individuals at all levels of the organization to conduct audits at specified intervals and report audit findings
- Facilitate and monitor the life-cycle of audit findings until completion
- Promote continuous improvement of systems, products, and services
- Establish and maintain QMS systems that are in conformance with international and local requirements
- Develop, manage and execute inspection readiness programs across the GRAIL QMS to ensure site readiness at all times
- Manage and support the external regulatory compliance inspections (CAP, NYSDOH, FDA, IVDR)
- Provide guidance to assist in the development, implementation, and maintenance of the Quality Management Systems
- Develops and provides inspection execution related training in support of compliance systems and quality improvements
- Partners with various internal and external groups to help analyze problems
- Develops and creates audit reports, coordinates action plans, and follow-up with auditee to assure prompt and adequate completion of agreed upon actions
- Establishes and conducts sectional readiness training for GRAIL functions
- Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors
- Directly responsible for ongoing maintenance and continuous improvement of this audit program
- Coaches/mentors staff as a means to ensure performance and professional development
Requirements
- BA/BS and10+ years in Quality Assurance.
- Minimum of 10 years of GMP auditing work experience in the medical device, pharmaceutical, or biotech industry.
- Experience in medical devices, manufacturing IVD, clinical diagnostic, CAP/CLIA or similar experience is preferred.
- Extensive knowledge of good manufacturing, strong understanding of FDA, ICH and IVDR regulations and Quality Systems; Solid background in Quality Assurance/ Systems.
- Outstanding auditing skills and attention to detail with audit program implementation including interpreting regulations, guidelines, and identification of compliance issues.
- Demonstrated broad expertise related to the principles and application of quality and regulatory compliance.
- Displays highly developed organizational leadership qualities and effective coaching abilities.
- Listening, interpreting, and summarizing information skills must be highly developedExcellent communication and writing skills; Proactive, energetic, self-assured professional with high personal integrity and ability to develop good interpersonal relationships.
- Ability to work effectively in a collaborative team environment where results are achieved through influence and incorporating multiple points of view.
- Must be able to work in a biohazard environment and comply with safety policies and standards outlined in the Safety Manual.
Benefits
- participate in an annual bonus plan tied to company and individual performance
- incentive plan
- long-term incentive plan
- flexible time-off
- 401k with a company match
- medical, dental, vision plans
- carefully selected mindfulness offerings
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
Quality Management SystemsGMP auditingaudit program implementationregulatory complianceinspection readiness programsdata analysistraining developmentproblem analysisquality assurancecompliance issue identification
Soft skills
organizational leadershipcoachingcommunicationinterpersonal relationshipscollaborationattention to detailproactiveenergeticself-assuredlistening
Certifications
BA/BSGMP certification
