Vice President, Quality Assurance

This is a fully remote position, open to applicants in Tennessee.

📋 Description

• Build and manage a high-performing global Quality Assurance team.

• Ensure adherence to data privacy standards, quality oversight, and regulatory compliance.

• Supervise all GxP activities and the performance of the Quality Management System.

• Lead and collaborate with Operations, Quality, and other departments on quality issues, escalations, and regulatory obligations.

• Act as the Data Privacy Officer.

• Oversee quality assurance and quality control initiatives, metrics, and the promotion of a quality culture.

• Support vendor, client, and internal audit programs, including vendor qualification, monitoring, CAPA, and issue resolution.

• Ensure that global quality team resources, expertise, and processes align with relevant regulations and client agreements.

• Develop the annual strategic Quality Plan.

• Assess regulatory and compliance risks during contractual negotiations and ensure clarity in client Quality agreements.

• Serve as a quality and regulatory advisor to partners and clients.

• Represent LC Quality in various forums.

• Provide quality guidance for strategic projects and initiatives.

• Ensure proper GxP training and annual retraining for LC personnel.

• Maintain the Quality Management System along with relevant quality processes and procedures.

• Monitor regulatory and industry standards and implement best practices for continual improvement.

• Perform additional related duties as assigned.

⛳️ Requirements

• Bachelor's degree from a four-year college or university, with 12-15 years of related experience and/or training; or a combination of education and experience.

• Over 10 years of progressively responsible experience in developing and leading global teams in regulated environments (biotech, central labs, and/or pharmaceutical companies) with a strong focus on Quality.

• Demonstrated experience managing FDA inspections, client audits, and quality oversight throughout drug development, approval, and post-market (GxPs).

• Strongly preferred: Experience in clinical trials, clinical laboratories, FDA 21CFR11/GCP, and GxP.

• Certifications and a comprehensive understanding of applicable global regulations.

• Experience with Veeva Vault is highly desirable.

• Proven leadership and supervisory skills and experience.

• Strong analytical, planning, and problem-solving capabilities.

• Ability to collaborate effectively with the CQO as a strategic partner.

• Global work experience with teams and clients across diverse cultures and time zones.

• Ability to adhere to established timelines, processes, and procedures.

• Exceptional attention to detail.

• Self-motivated with the ability to work independently and as part of a team.

• Capacity to adapt to changing environments and requirements.

• Ability to make prompt and well-considered decisions.

• Excellent organizational, time management, communication, multitasking, interpersonal, and listening skills.

• Business acumen to foster a quality culture while achieving both short- and long-term business objectives.

• Proficiency 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 notes.

• Ability to apply basic mathematical skills and abstract reasoning.

• Capability to resolve practical problems, investigate issues, and draw logical conclusions.

• Willingness to travel as needed/requested.

🏝️ Benefits

• Ability to travel as needed/requested.

• Reasonable accommodations may be made to assist individuals with disabilities in performing essential job functions.