Q2 Solutions is a leading clinical trial laboratory services organization with end-to-end laboratory services and secure, enterprise-wide biospecimen and consent management solutions. With a relentless focus on quality and innovation, Q2 Solutions uses its global experience and scientific expertise to transform science and data into actionable medical insights that help customers improve human health. A joint venture of IQVIA (formerly QuintilesIMS) and Quest Diagnostics, Q2 Solutions combines the best of each parent organization's clinical trials laboratory services capabilities to fulfill its mission of treating each sample as if a life depends on it.
- Plan, conduct, and report audits of processes, systems, projects and/or sites within budget and established timelines.
- Oversee and host the conduct of QA inspections and audits by clients and regulatory agencies and Mock FDA Inspections.
- Prepare, review and approve corrective action plans.
- Promote the concept of quality, the principles of quality management and devise and implement quality improvements.
- Ensure implementation of Corporate Policies.
- Represent QA on project related activities.
- Act as a resource on all aspects of GXP and related guidelines and regulations.
- Manage staff in accordance with organization's policies and applicable regulations. Responsibilities include planning, assigning, and directing work; appraising performance and guiding professional development; rewarding and disciplining employees; addressing employee relations issues and resolving problems. Approve actions on human resources matters.
- Oversee and participate in the documentation, reporting, and closure of compliance issues.
- Organize and deliver training to other IQVIA departments concerning the activities of Quality services, results of activities, quality initiatives, GXP etc.
- Serve as Regional or Global QA Liaison for assigned customers, therapeutic groups and/or functional areas.
- Use the data available from Quality Assurance database (EDA) to provide information, metrics and trend analysis to assigned project, operational and regional units on the quality of procedures, practices, projects and systems.
- Ensure the follow-up of major and critical audit findings to ensure that appropriate actions have been taken and have adequately resolved the issues identified.
- Maintain an excellent knowledge of current GXP regulations, guidelines, and related auditing techniques appropriate to work responsibilities.
- Provide regular feedback to Quality Management, on the above activities.
- Represent IQVIA at industry meetings, conferences, and seminars with presentations and training.
- Provide interpretation and consultation to project teams on regulations, guidelines, compliance status, and policies and procedures.
- Evaluate policies and procedures for compliance with applicable regulations/guidelines and provide recommendations to management for continuous process improvements.
- Serve as author of Quality Assurance SOPs as assigned.
- Advise Quality Assurance management on system audit needs
- Ensure the Quality Assurance database is maintained and up-to-date to reflect the status of audits being scheduled, auditor assignment and audit reporting and/or follow-up status.
- Act as line manager for one or more QA staff.
Knowledge, Skills and Abilities
- An excellent knowledge of current GXP regulations and guidelines, and associated regulatory requirement.
- Knowledge of word-processing, spreadsheet, and database applications.
- Extensive knowledge of pharmaceutical research and development processes and regulatory environments.
- Considerable knowledge of quality assurance processes and procedures.
- Strong interpersonal skills.
- Excellent problem solving, risk analysis and negotiation skills.
- Effective organization, communication, team orientation, and leadership skills.
- Ability to work independently with initiative.
- Ability to manage multiple projects.
- Ability to manage staff
- Strong training capabilities.
- Ability to establish and maintain effective working relationships with coworkers, managers and clients
- Understands basic management approaches such as work scheduling, prioritizing, coaching and process execution.
Minimum Education and Experience
- 7 years of Quality Assurance experience in pharmaceutical, technical, or related area, including GCP Quality Assurance experience
- 5 years of management experience
- Bachelor's Degree or equivalent combination of education, training and experience
IQVIA is an EEO Employer - Minorities/Females/Protected Veterans/Disabled
IQVIA, Inc. provides reasonable accommodations for applicants with disabilities. Applicants who require reasonable accommodation to submit an application for employment or otherwise participate in the application process should contact IQVIA's Talent Acquisition team at email@example.com to arrange for such an accommodation.
Job ID: R1097208