Closing Date: 13 Feb 17
Type: Full Time
Salary (£): Negotiable
Quintiles (NYSE: Q) is the world’s largest provider of biopharmaceutical development and commercial outsourcing services with a network of more than 29,000 employees conducting business in approximately 100 countries. We helped develop or commercialize all of 2013’s top-100 best-selling drugs on the market. ...
Quintiles (NYSE: Q) is the world’s largest provider of biopharmaceutical development and commercial outsourcing services with a network of more than 29,000 employees conducting business in approximately 100 countries. We helped develop or commercialize all of 2013’s top-100 best-selling drugs on the market.
Quintiles applies the breadth and depth of our service offerings along with extensive therapeutic, scientific and analytics expertise to help our customers navigate an increasingly complex healthcare environment as they seek to improve efficiency and effectiveness in the delivery of better healthcare outcomes. To learn more about Quintiles, please visit www.quintiles.com
Oversee and coordinate the quality assurance program for assigned customer projects at a regional and/or global level. Provide support in the promotion and assessment of compliance with regulations, guidelines, and operating procedures among sites within the region and globally as assigned. Act as line manager for one or more QA staff. Serve as primary backup for QA management.
? Plan, schedule, conduct, report and close audit activities in any of the countries involved with corporate contracts.
? Assist in establishment of quality assurance and control policy by providing consultation and recommendations to regional and Global QA Management
? Serve as author for QA SOPs and may act as regional QA representative to the global QA SOP taskforce
? Serve as QA representative on Global SOP Taskforce(s) for other Quintiles functional areas as assigned
? Participate in or lead teams for special projects as assigned. Teams may be cross functional.
? Provide guidance, interpretation, support, training, and key input to development groups for consultation and interpretation of regulations, guidelines, corporate standards, and policies.
? Host customer audits and participate in review of corrective action plans. • Recommend systems for audit, write systems audit plans and coordinate scheduling, conduct, reporting and closure of internal system audits.
? Serve as Global QA Contact for assigned customers and Quintiles functional areas.
? Oversee documentation, reporting, and closure of compliance issues.
? Support QA Management in proposal reviews and reporting QA metrics.
? Act as primary back-up for QA management.
? Conduct trend analysis of audit results and provide QA management with initial root cause analysis.
? May present trend analysis results and QA metrics to Quintiles upper management.
? Ensure proper coordination of customer-initiated audits and mock regulatory inspections, and manage regulatory facility inspections.
? 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.
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.
? Considerable knowledge of quality assurance 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
? 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/primary degree
? 12 years Quality Assurance experience in pharmaceutical, technical, or related area, including GCP Quality Assurance experience; 5 years of management experience; or equivalent combination of education, training and experience; or equivalent combination of education, training and experience
? 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.
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