The posting
Summary: The Vice President, Quality Assurance is responsible for building and leading an effective team globally and ensuring data privacy, quality oversight and regulatory compliance. He/she is accountable for the quality oversight of all GxP activities and performance of the QMS. They lead and collaborate with other functions to achieve organizational quality standards and GxP compliance, set quality goals and standards for LC, and oversee the Quality Assurance and Quality Control function. This is a pivotal role that drives quality initiatives, cross collaboration, and continuous improvement to promote quality culture and excellence. This position is ideally suited for candidates within commuting distance to Johnson City, TN or in the Eastern US time zone. General responsibilities include but are not limited to: Responsibilities:
Leads and directs Operations, Quality and other functions on quality matters, escalations and regulatory requirements. Partners with all functions for managing, informing and driving a culture of quality in the entire organization. Serves as Data Privacy Officer for the organization. Provides oversight of quality assurance and quality control activities. Including identifying and reporting on key Quality metrics to measure performance and drive excellence/RFT culture. Supports an audit program consisting of vendor, client and internal audits; provides oversight of the vendor qualification and monitoring including appropriate CAPA and issue resolution. Leads a global quality team to ensure adequate resourcing, expertise and processes that govern LC operations and comply with application regulations and client agreements. Creates annual strategic Quality Plan. Provides regulatory and compliance risk review of contractual negotiations. Ensures clarity on Quality agreements with Clients. Serves as quality and regulatory advisor to partners and clients where applicable. Represents LC Quality at various forums. Participates in and provides quality guidance for strategic projects and plans. Ensures a training program that provides LC personnel engaged in GxP activities are adequately trained, including annual retraining. Accountable for the Quality Management System and all applicable quality processes and procedures. Maintains a working knowledge of regulatory and industry requirements and best practices and implements as appropriate. Performs other related duties and tasks as necessary or as assigned.
Education and Qualifications:
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.
Required Skills
Proven leadership/supervisory ability and experience. Ability to strategize and solve problems and have strong leadership skills. Strong analytical skills and proven ability to work effectively with the CQO as a strategic partner. Ability to travel as needed/requested. 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. Strong planning and problem-solving skills. Self-motivation and ability to work well independently, as well as using a collaborative team approach. Excels at adapting to changing environments and requirements. Ability to make quick and well-thought-out decisions. Excellent organization and time management skills, communication, multitasking, interpersonal and listening skills. Business acumen to drive a quality culture while meeting and advancing business short term and long-term goals. Proficient in Microsoft Word, Excel, and database software.
Language Ability: Ability to read, write and comprehend internal and external correspondence, meeting agendas and meeting notes. Mathematical Ability: Ability to apply simple mathematical skills and abstract thinking in a logical and organized manner. Reasoning Ability: Ability to solve practical problems, investigate issues, draw correct and logical conclusions; the ability to understand instructions, mathematical and diagrammatic representations of data in both an abstract and concrete manner. Computer Skills: To perform this job successfully, an individual must have advanced working knowledge of Microsoft Office applications and proficiency in finance software and technology. Supervisory Responsibilities: Management and Specialist levels Work Environment: The noise level in the work environment is usually moderate. Physical Demands: While performing the duties of this job, the employee is regularly required to sit. The employee is frequently required to talk or hear. The employee is occasionally required to stand; walk and reach with hands and arms. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision and ability to adjust focus. This job description should not be construed to imply that these requirements are the exclusive standards of the position. Incumbents will follow any other instructions and perform other related duties as may be required by their supervisor. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of the job.
