Sr. Manager, QMS Vendor Management & Compliance
Skills
- Strong knowledge of FDA, GMP, GLP, GCP regulations, and ICH guidelines.
- Expertise in FDA inspection management, internal and third-party audits.
- Proven ability to lead cross-functional teams in a regulated environment.
- Excellent communication skills for interaction with regulatory agencies and executive leadership.
Responsibilities
- Develop and implement FDA inspection readiness strategies including training and mock inspections.
- Manage internal and third-party audit programs ensuring regulatory compliance and CAPA effectiveness.
- Collaborate across clinical, QC, and manufacturing teams to drive quality culture and continuous improvement.
- Serve as liaison for FDA and regulatory agency inspections, managing observation responses.
- Oversee Quality Management System processes such as document control, CAPA, deviations, and change control.
- Lead vendor qualification, auditing, and risk assessment activities to maintain compliance.
- Conduct quality training programs to enhance organizational compliance awareness.
- Provide strategic guidance on regulatory compliance trends to senior leadership.
Education
- BA or BS degree in a related field.
Benefits
- Competitive compensation package.
- Comprehensive benefits.
- Equity component.
Average salary estimate
If an employer mentions a salary or salary range on their job, we display it as an "Employer Estimate". If a job has no salary data, Rise displays an estimate if available.
Be a vital part of FinChat's journey as a Quality Assurance Engineer, shaping the future of AI-driven investment research.
Join Coinbase as a Lead TMS Quality Compliance Analyst and help shape the future of the global financial system.
Join Rezilient Health as a Product QA Specialist, where you will drive process improvement and collaboration across our innovative healthcare team.
CD PROJEKT RED's Boston studio needs a Senior Gameplay QA Analyst to lead testing and quality assurance for complex gameplay systems in Cyberpunk 2.
Join PHIL as a Senior Test and Platform Operations Engineer to drive quality and reliability in our cutting-edge health-tech platform.
PNC is hiring a remote Quality Manager to lead and improve the CLLO Lookback team's quality management and operational risk efforts.
As a Senior Quality Assurance Analyst at NewRocket, you will ensure that ServiceNow solutions meet high-quality standards through meticulous testing and process analysis.
We are looking for a driven QA/QC Manager for Process Piping to join WWPS, focusing on quality assurance in large-scale construction projects.
Lead quality assurance operations on the night shift to maintain excellence in food safety and product quality within a dynamic manufacturing setting.
Become a key player in Testronic's Localization Quality Assurance team as a Game Tester, utilizing your language skills and passion for gaming.
Manufacturing Quality Engineer sought to maintain high-quality standards and regulatory compliance in medical device manufacturing at Allurion's Natick facility.
Join WORLD WIDE PROFESSIONAL SOLUTIONS as a QA/QC Manager and play a pivotal role in ensuring quality standards in industrial construction.
Lead QA strategies and automation efforts ensuring high reliability and performance of Salesforce and custom-built applications in a fast-paced tech environment.
Vaxcyte is a people-first organization inspired by an audacious mission to develop best-in-class vaccines to prevent a host of deadly infectious diseases.
60 jobsSubscribe to Rise newsletter
🔮
Hi, I'm Risa! Your AI Career Copilot
you, just ask me below!
