Technical Quality Manager

Job Category: IT/Software Development Career Level: Experienced (Non-Manager) Location: 02451           Job Description: PAREXEL International Corporation is a leading global bio/pharmaceutical services organization, providing a broad range of knowledge-based contract research, medical marketing and consulting services to the worldwide pharmaceutical, biotechnology and medical device industries. Committed to providing solutions that expedite time-to-market and peak-market penetration, PAREXEL has developed significant expertise across the development and commercialization continuum, from drug development and regulatory consulting to clinical pharmacology, clinical trials management, medical education and reimbursement. Headquartered near Boston, Massachusetts, PAREXEL operates in 55 locations throughout 43 countries around the world, and has over 6,315 employees. For more information about PAREXEL International visit www.PAREXEL.com The Project Manager, Technical Process and Systems Implementation will provide technical expertise, resource and mentoring for the implementation, computer systems validation (CSV) and ongoing support & maintenance activities related to systems used by CRS staff in clinical trial activities. General responsibilities include leading implementation projects for systems, managing CSV activities, providing quality management support pertaining to technical activities, and representing CRS systems in audit/inspections. Work to the appropriate corporate standards of quality and efficiency, WSOPs/Guidelines, ICH-GCP and/or other international regulations as applicable. Key Accountabilities' Promote a positive, results orientated work environment, build partnerships and model teamwork, communicate to others in an open, balanced and objective manner' Deliver best value and high quality service for the benefit of CRS and ensure compliance with Corporate Quality standards, Controlled Documents and appropriate regulations' Lead the implementation of new functional, or cross-functional, systems and tools in line with CRS Operations and CRS Quality Management strategies' Perform required tasks associated with delivering systems projects including management of stakeholder expectations, scope of work, communication, team management, planning, initiation, execution and closeout' Develop and implement project plan, as required, for assigned projects ' Manage project budgets, as required, for assigned projects' Participate in systems implementation teams and support pilot study activities' Document user requirements and provide input into design specifications to ensure these are met' Lead the ongoing CSV tasks on assigned projects and provide leadership to validation teams' Act as Designated Responsible Individual (DRI) for assigned systems' Prepare, review and maintain relevant Controlled Documents' Develop, review and maintain technical training materials as required' Provide technical training, support and advice to operational groups on the use of systems including adherence to applicable processes ' Perform hand-off of tasks to relevant groups such as Process and Training, as required' Use process mapping and analysis techniques to support process improvements within operations, with subsequent development and implementation of processes' Keep abreast of regulatory requirements and represent CRS systems at regulatory inspections, audits and/or client audits' Represent CRS in system improvement initiatives' Initiate escalation of significant quality events to Management as required' Train and mentor less experienced Technical Specialists ' Perform all tasks as reasonably requested Skills' Exhibits competency across core project management activities' Excellent interpersonal, verbal and written communication skills, business understanding, negotiation skills and strong organizational skills' Personal qualities that include the ability to gain trust and confidence with a variety of clients within PAREXEL' Ability to work in an action-oriented, fast-paced and rapidly changing environment' Ability to prioritize workload and manage multiple and varied tasks with enthusiasm ' Ability to make appropriate decisions in ambiguous situations' Client-focused approach to work' Exhibits a sense of urgency about solving problems and completing work' Culturally aware and ability to think and work globally' Ability to lead a 'virtual', global team as required' Understand the strengths and development areas of team members' Actively seeks opportunities to develop experience and knowledge' Ability to travel as needed for the position and to support other officesEducation' Masters/Bachelors degree in a science, technology or industry related discipline Language Skills' Excellent English written and oral communication skillsMinimum Work Experience' Relevant clinical trials and / or research work experience preferred with emphasis on GCP and compliance' Good experience and understanding of technology as it relates to clinical trial activities, including System Life Cycle process and applicable GCP regulations pertaining to Computer Systems' Project Management or Management experience preferred RESPOND HERE! Respond immediately by accessing the following dedicated online response form which will allow you to cut and paste your resume. This form will go directly and immediately to the hiring authority for this position. Access the online response form at: http://sh.webhire.com/servlet/resp/rf?jobid=2261216&boardid=749