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Senior Director, Project Quality & Risk Management

Employer
Parexel International
Location
Baltimore, MD
Closing date
Jul 24, 2019
Quality Assurance Opportunities at Parexel By being hired into one of our Quality Assurance jobs at Parexel International, you'll be a key member of the Parexel International team. Professionals in Quality careers come from a variety of backgrounds, bringing an assortment of knowledge and skills to every area of our business. A job in Quality at Parexel International may be waiting for you! Senior Director, Project Quality & Risk Management Apply Now Job ID 53724BR Responsible for quality oversight globally across the Early Phase Clinical Units. Provide management support to other Project Quality & Risk Management, staff. Identify and lead initiatives relating to quality improvement at the project, client, department, or cross department level. Provide management support to the team. Support Senior Management with the implementation & monitoring of the vision, mission, strategic & tactical goals of the Project Quality & Risk Management group, to ensure they are being met. * Recruit qualified staff. * Ensure that CVs and Job Descriptions are maintained. * Ensure that staff are appropriately trained when they join the group and thereafter on an ongoing basis. * Ensure that performance objectives and a development plan are documented for each employee and that these are reviewed at least annually. * Verify training compliance at minimum during performance management meetings. * Provide coaching, mentoring and constructive feedback to employees. Ensure that resources are adequate. If they are not, provide a business case to senior management * Maintain a positive, results oriented work environment, building partnerships within the group and across the organization at large, modeling teamwork * Provide oversight and serve as an escalation point where management support and intervention are indicated. * Work closely and collaboratively with other Management within and outside Project Quality & Risk Management. A * Share trend data and lessons learned * Identify and lead initiatives relating to quality improvement at the project, client, department, or cross department level. Actively participate in relevant external meetings and / or associations. Represent PAREXEL Quality and PQRM department in client meetings, bid defense meetings, feasibility assessments and audits or inspections, as necessary. * Build and maintain relationships with clients. Fulfill role of Quality Sponsor or Portfolio Quality Lead or Client Quality & Risk Lead as assigned. Serve as quality consultant for assigned accounts to senior project leadership personnel and assist with the oversight of quality aspects of the client program * Review key portfolio documentation from a quality standpoint * Facilitate portfolio level compliance with the Corrective and Preventive Actions (CAPA) * Provide audit and inspection support for portfolio, including, where feasible, advising the project teams during preparation and conduct of audits and inspections as per applicable SOPs. Review and provide feedback on portfolio related audit/inspection responses generated by project team members per applicable SOPs. Represent Quality Management in audits and inspections as assigned. * Oversee the collection and reporting of portfolio quality metrics. Evaluate the quality status of a portfolio by reviewing applicable quality metrics. Provide expert quality support within one or more projects or across projects, as assigned. Identify process improvement opportunities. Report process gaps and participate in implementation of process improvement. * Develop and Innovate new methods and strategies to increase efficiency of Project Quality & Risk Management and develop business cases and proposals for their implementation * Maintain an understanding of PAREXEL standard operating procedures that are relevant to the assigned project(s) and of relevant regulations and guidelines. Maintain compliance with training curriculum * Consult process SMEs as necessary for guidance * Where assigned, work with Operational groups to provide expert review of client-defined processes/quality and/or training materials. * Perform Clinical Delivery Unit (CDU) Quality Lead role (where assigned), acting as a direct Quality liaison for the CDU Heads, including but not limited to duties listed within this section * Support audits and inspections as Host/Co-Host/Other support, as assigned. Qualifications Skills: * Leadership and management skills * Excellent interpersonal, verbal and written communication skills * Client focused approach to work * Project management skills and experience * Able to handle several highly complex projects simultaneously and entire programs, potentially spanning multiple strategic business units (SBUs) * Able to work independently, take initiative, and have a flexible approach with respect to work assignments and new learning * Able to manage multiple and varied tasks with enthusiasm, and prioritize workload with attention to detail and strong organizational skills * Able to work effectively in a matrix environment and to demonstrate and foster teamwork within the group as well as across the organization * Must be IT literate: experienced with Microsoft based applications and general knowledge of personal computer functions * Able to travel approximately 30%-50%. * Substantial relevant experience (eg, in the pharmaceutical or CRO industry) * Prior management experience Education: * Educated to degree level (technology, biological science, pharmacy or other health related discipline preferred) or equivalent qualification or clinical research experience. * Master's degree in a science, technology or industry EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. Apply Now Apply Later Share this Job * Facebook * Twitter * LinkedIn * Email Our Location United States View Map Sign Up for Alerts Get the latest Parexel career opportunities as soon as they become available. First Name Last Name Most Recent Job Title Email Address Mobile Number Are you interested in a home based position? Areas of Interest Enter category and/or location, then click add. Job Category Location * Quality Assurance, United StatesRemove * Remove Confirm Email Recently Viewed Jobs You have not recently viewed any jobs View all jobs Global recruitment events * Leadership and management skills * Excellent interpersonal, verbal and written communication skills * Client focused approach to work * Project management skills and experience * Able to handle several highly complex projects simultaneously and entire programs, potentially spanning multiple strategic business units (SBUs) * Able to work independently, take initiative, and have a flexible approach with respect to work assignments and new learning * Able to manage multiple and varied tasks with enthusiasm, and prioritize workload with attention to detail and strong organizational skills * Able to work effectively in a matrix environment and to demonstrate and foster teamwork within the group as well as across the organization * Must be IT literate: experienced with Microsoft based applications and general knowledge of personal computer functions * Able to travel approximately 30%-50%. * Substantial relevant experience (eg, in the pharmaceutical or CRO industry) * Prior management experience Education: * Educated to degree level (technology, biological science, pharmacy or other health related discipline preferred) or equivalent qualification or clinical research experience. * Master's degree in a science, technology or industry

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