Vice President, Quality Assurance
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Job Description
Vice President leading global Quality Assurance, data privacy and GxP compliance for a regulated life-sciences organization. Overseeing QMS, audits, FDA inspections and quality teams.
Responsibilities:
- Build and lead an effective global Quality Assurance team
- Ensure data privacy, quality oversight and regulatory compliance
- Oversee all GxP activities and Quality Management System performance
- Lead and collaborate with Operations, Quality and other functions on quality matters, escalations and regulatory requirements
- Serve as Data Privacy Officer
- Oversee quality assurance and quality control activities, metrics and quality culture initiatives
- Support vendor, client and internal audit programs, including vendor qualification, monitoring, CAPA and issue resolution
- Ensure global quality team resourcing, expertise and processes comply with applicable regulations and client agreements
- Create the annual strategic Quality Plan
- Review regulatory and compliance risks in contractual negotiations and ensure clarity of client Quality agreements
- Serve as quality and regulatory advisor to partners and clients
- Represent LC Quality at forums
- Provide quality guidance for strategic projects and plans
- Ensure adequate GxP training and annual retraining for LC personnel
- Maintain the Quality Management System and applicable quality processes and procedures
- Monitor regulatory and industry requirements and best practices and implement improvements
- Perform other related duties as assigned
Requirements:
- Bachelor's degree from four-year college or university with 12-15 years related experience and/or training; or equivalent combination of education and experience
- 10+ years of progressive experience in building and leading global teams in regulated environments (biotech, Central labs and/or Pharma companies) with a specific focus on Quality
- Proven experience managing FDA inspections, client audits and quality oversight across drug development, approval and post market (GxPs)
- Strongly preferred: Experience in clinical trials, clinical laboratory, FDA 21CRF11/GCP, GxP
- Certifications and thorough understanding of applicable global regulations
- Veeva Vault experience highly desired
- Proven leadership/supervisory ability and experience
- Strong analytical, planning and problem-solving skills
- Ability to work effectively with the CQO as a strategic partner
- Global work experience with teams and clients across cultures and time zones
- Ability to adhere to established timelines, processes and procedures
- Excellent attention to detail
- Self-motivation and ability to work independently and collaboratively
- Ability to adapt to changing environments and requirements
- Ability to make quick and well-thought-out decisions
- Excellent organization, time management, communication, multitasking, interpersonal and listening skills
- Business acumen to drive quality culture while meeting short- and long-term business goals
- Proficient in Microsoft Word, Excel, database software, Microsoft Office applications, finance software and technology
- Ability to read, write and comprehend internal and external correspondence, meeting agendas and meeting notes
- Ability to apply simple mathematical skills and abstract thinking
- Ability to solve practical problems, investigate issues and draw logical conclusions
- Ability to travel as needed/requested
Benefits:
- Ability to travel as needed/requested
- Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of the job
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