Associate Director, Quality Assurance avoin työpaikka, Quintiles | Avoimet työpaikat

Quintiles is currently recruiting for a Director, Quality Assurance - Europe. The key purpose to this role is to 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 back-up for QA management.

Responsibilities include but are not limited to;

RESPONSIBILITIES

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).

Qualifications

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
Extensive Quality Assurance experience in pharmaceutical, technical, or related area, including GCP Quality Assurance experience; management experience; or equivalent combination of education, training and experience; or equivalent combination of education, training and experience

Primary Location

: GBR-ENG-Berkshire

Other Locations

: Portugal, Italy, Spain, Belgium, France, Germany, DNK-Copenhagen, Netherlands, Ireland, Sweden

Organization

: GBR02 - UK Product Development

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» Avoin työpaikka: Associate Director, Quality Assurance, Quintiles

Associate Director, Quality Assurance

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