Director, Quality Assurance - (R1034607) in Ithaca, NY at IQVIA™

Date Posted: 7/12/2018

Job Snapshot

  • Employee Type:
    Full-Time
  • Location:
    Ithaca, NY
  • Experience:
    Not Specified
  • Date Posted:
    7/12/2018
  • Job ID:
    R1034607

Job Description

Description

PURPOSE
The Director, Quality Assurance (QA) has responsibility for establishing and maintaining a site compliance program for Good Laboratory Practices (GLP) for nonclinical development to assure management that the facilities, equipment, personnel, methods, practices, records and controls for each nonclinical laboratory study are in compliance with current GLP regulations as well as consistent with client expectations and requirements to positively impact company performance. This position is responsible for the successful and timely execution of the internal audit program, planning and implementation of quality improvement projects, departmental budget, regulatory compliance training, and quality assurance unit (QAU) staff training and line management.
 
RESPONSIBILITIES
  • Provides clear direction and vision to the QAU and laboratory teams that ensures the quality programs of the Bioanalytical and ADME Laboratory are consistent with client and regulatory requirements and expectations.
  • Supports all human resources policies, such as performance development, recruiting and interviewing standards.
  • Develops direct reports and sets manageable objectives and goals for career development that also support company objectives.
  • Develops, evaluates and supports process and procedural improvements that are consistent with client and regulatory agency expectations to improve the quality, efficiency, and effectiveness of company operations.
  • Provide the required quality assurance support for data submission to regulatory bodies (e.g. GLP Study Report). 
  • Monitors the QAU staff performance, sets project priorities and ensures deadlines are met to support client projects through effective teamwork, organization, and management.
  • Maintains organizational awareness of regulatory developments and requirements and has responsibility for ensuring all potential GxP compliance issues are identified and brought to the attention of appropriate business managers in a timely manner.
  • Stays current with industry trends and developments through active involvement with external professional groups.
  • Leads audits and/or inspections of all laboratory facility, process, and study data generated from such to ensure regulatory compliance.
  • Serves as the primary escort and coordinator of inspections by external visitors and regulatory agencies.
  • Reviews all SOPs to ensure compliance to regulatory requirements and established company procedures.
  • Assure QA oversight of computer system validation projects to meet regulatory requirements.
  • Establishes budgets for area of responsibility and works within established budgets.
 

Job Requirements

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
 
  • Knowledge of word-processing, spreadsheet, and database applications.
  • Extensive knowledge of current Good Laboratory Practices (GLP) and pharmaceutical research and development processes in regulated environments.
  • Considerable knowledge of quality assurance principles, processes and procedures.
  • Strong interpersonal skills.
  • Excellent problem solving, risk analysis and negotiation skills.
  • Effective organization, communication, and team orientation skills
  • Senior Management experience in Quality Assurance / Regulatory Compliance.
  • Ability to influence and guide others at all levels of management.
  • Demonstrated ability to lead and manage multiple responsibilities.
  • Ability to manage costs effectively through appropriate resource allocation.
  • Ability to articulate and define departmental needs and processes.
  • Ability to establish and maintain effective working relationships with coworkers, managers and clients
 
 
MINIMUM REQUIRED EDUCATION AND EXPERIENCE
 
  • Bachelor’s degree in life sciences
  • Minimum of 12 years Quality Assurance experience in laboratory, pharmaceutical, technical, or related area, including GLP Quality Assurance experience
  • Minimum of 5 years of management experience; or equivalent combination of education, training and experience;  
  • Regulatory and/or Operations experience in pharmaceutical industry a plus
 
PHYSICAL REQUIREMENTS          
  • Position requires a significant amount of writing and keyboarding involving repetitive motions with fingers and sitting for prolonged periods of time.
  • Position requires extensive use of telephone and face-to-face communications, which requires the accurate perception of speech.
  • Travel is required and may include some international travel.
 
 
EEO Minorities/Females/Protected Veterans/Disabled

Job ID: R1034607