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.
? ****uate 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 **** plans.
? Prepare, review and approve corrective **** 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.
? ****uate 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.
?
All responsibilities are essential job functions unless noted as nonessential (N).
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
? Knowledge of word-processing, spreadsheet, and database applications.
? Extensive knowledge of pharmaceutical research and development processes and regulatory environments.
JOB DE****ION
? Considerable knowledge of quality assurance processes and procedures.
? Strong interpersonal skills.
? Excellent problem solving, risk analysis and negotiation skills.
? Exceptional training capabilities.
? Effective organization, communication, team orientation, and leadership skills.
? Ability to work independently with initiative.
? Ability to manage multiple projects.
? Ability to establish and maintain effective working relationships with coworkers, managers and clients
MINIMUM REQUIRED EDUCATION AND EXPERIENCE
? Bachelor’s/primary degree
? 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
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.
? Occasional travel.

The worlds leading pharmaceutical services organization is powering the next generation of healthcare. If you want to make a difference in global healthcare, There is the place for you. Youll be connected with an organization that is changing the way drugs are developed, profiled and marketed. More than 19,000 people throughout the world have already chosen to join Here.
Of the worlds top 30 best-selling drugs, We have helped to develop or commercialise every single one. This is an outstanding opportunity to join us and become an integral part of our team.