Quality Assurance Manager
Quintiles pioneered the idea of helping pharma companies conduct objective clinical trials to establish not only whether a drug is effective, but who can take it safely. Our customers have relied on us to design and conduct rigorous clinical research for decades, from small studies to multinational mega-trials. However, we continue to develop new ways of interpreting and evaluating data that allow us to create more effective trials and determine outcomes faster. If that is your passion, we have a place for you.
Provide support to Management in the promotion and assessment of compliance with regulations, guidelines, and operating procedures. Manage QA oversight of projects, assignments, and training. Conduct independent audits to assess compliance with regulations, guidelines, and operating procedures. Prepare and distribute reports of findings to operations staff, management, and customers. Provide consultation in interpretation of regulations, guidelines, policies, and procedures.
- Plan, schedule, conduct, report and close audit activities in any of the countries involved with Quintiles contracts. Audits are conducted to assess compliance with applicable regulations/guidelines, customer requirements, Quintiles SOPs and project specific guidelines/instructions.
- Evaluate audit findings and prepare and distribute reports to operations staff, management, and customers.
- Provide interpretation and consultation to project teams on regulations, guidelines, compliance status, and policies and procedures.
- Provide consultation to customers, functional leads and monitors in interpretation of audit observations and formulation of corrective action plans.
- Prepare, review and approve corrective action plans
- Present educational programs and provide guidance to operational staff on compliance procedures.
- Conduct quality assurance consultancy activities and projects for clients within budget and established timelines.
- Evaluate policies and procedures for compliance with applicable regulations/guidelines and provide recommendations to management for continuous process improvements.
- Host customer audits
- Host mock regulatory inspections and regulatory facility inspections
- Provide training for new Quality Assurance staff.
- Serve as author of Quality Assurance SOPs as assigned.
- Advise Quality Assurance management on system audit needs.
- Act as regional or Global QA Coordinator for assigned customers projects
- Oversee documentation, reporting, and closure of compliance issues
- Lead Projects.
- Train new auditors and staff as required.
MINIMUM REQUIRED EDUCATION AND EXPERIENCE
7 years Quality Assurance experience in pharmaceutical, technical, or related area; or equivalent combination of education, training and experience; or equivalent combination of education, training and experience
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