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Senior Quality Manager TQM

Parexel International Corporation

Durham, North Carolina

Durham, NC

As Sr Quality Manager, TQM you will manage efforts to define, adopt and oversee compliance to processes and standards as the fundamental baseline for technology solution development, validation and delivery. Supports efforts, in collaboration with the business to monitor, identify and implement continuous process improvement across all technology business units.

You will manage validation efforts and provide expertise to ensure technology projects adhere to established standards and quality expectations. Manage activities to develop and perform assessments on technology projects to identify and mitigate risks and prevent quality concerns.

Manage monitoring and maintenance of oversight for the selection and implementation of technology solutions for quality management in support of delivery of products and services to customers. Manages the vision and direction for the development and implementation of Parexel’s business intelligence infrastructure, including in-depth analysis of key performance metrics and indicators of quality management and operational systems.

Key Accountabilities:

Quality Representative

Standards & Quality Framework

Technology Solution Project Quality Oversight

Commercial Services

Skills: Expert in computer technology quality and compliance (including computerized system validation) and the pharmaceutical industry across multiple disciplines within Clinical Drug Development (Phase I/II/III/IV) and/or Manufacturing.Advanced knowledge of continuous improvement methodologies.Exhibits competency across core project management activities.Excellent interpersonal, verbal and written communication skills, business understanding, negotiation skills and strong organizational skills.High ability to work in a customer-focused, fast-paced and rapidly changing environment with the high ability to prioritize workload and manage multiple and varied tasks with enthusiasm and supervision.Highly motivated, seeks opportunities for development, client-focused, having the ability to work with guidance on own initiative.Exhibits a sense of urgency when addressing problems and ensures completion of commitment.Culturally aware and ability to think and work globally.Intermediate desktop software skills (MS Office, Excel, Adobe PDF etc.)Knowledge & Experience:Expert in functionally managing teams to meet project goals.Clinical trials and /or research work experience required, with emphasis on GCP and technology compliance.Expert in technology as it relates to clinical trial activities, including System Life Cycle process and applicable GCP regulations pertaining to Computer Systems.Expert of project management, Lean Six-Sigma, auditing and/or risk management methodologies.QualificationsEducation:Educated to degree level (technology, biological science, pharmacy or other health related discipline preferred) or equivalent qualification, or 7+ years clinical research experience.Postgraduate degree in a science, technology or industry-related discipline preferred.Industry recognized qualification i.e. project management, Lean Six-Sigma, auditing and/or risk management.EEO DisclaimerParexel 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.

Job posted: 2021-05-19

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