QA Manager job at Quintiles
Quintiles is the world’s largest provider of biopharmaceutical development and commercial outsourcing services. We bring a fully integrated approach to build biopharma and life sciences solutions – from pipeline through portfolio to population health™. A career with Quintiles connects you to great opportunity to achieve professional success and impact healthcare around the world.
Description
At Quintiles we help healthcare and biopharma companies improve their probability of success. We do this by connecting our scientific, therapeutic and analytics expertise with superior delivery. From advisory through operations, Quintiles and its affiliate companies is the world’s largest provider of product development and integrated healthcare services.
As one of FORTUNE’s ‘Most Admired Companies’ in 2016, we offer great opportunities for a career in world-leading clinical research. Our global projects, innovative tools and industry leading customers combined with outstanding support from our leadership team and clear career mapping allows you to make a difference in patient health.
PURPOSE
Provide support to mgmt 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.
RESPONSIBILITIES
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.
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