Quality Manager

Company
PAREXEL
Location
Nottingham, England,United Kingdom
Salary
Competitive
Posted
05 Nov 2018
Closes
08 Feb 2019
Ref
47053BR
Manages efforts to define, adopt and oversee compliance to processes and standards as the fundamental baseline for technology development, validation and delivery across PAREXEL. Manages efforts, in collaboration with the business to monitor, identify and implement continuous process improvement across all technology business units.
Manages validation efforts, and provides expertise to ensure technology projects adhere to established standards and quality expectations. Manages activities to develop and perform assessments on technology projects to identify and mitigate risks and prevent quality concerns.

Manages 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 PAREXEL clients. 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.
QualificationsSkills:
  • Subject Matter Expert (SME) 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 including a strong focus on key performance indicators.
  • Excellent interpersonal, verbal and written communication skills, business understanding, negotiation skills and strong organizational skills.
  • Ability to work in a customer-focused, fast-paced and rapidly changing environment with the ability to prioritize workload and manage multiple and varied tasks with enthusiasm.
  • Highly motivated, seeks opportunities for development, client-focused, and has the ability to work unsupervised and on own initiative, which includes making appropriate decisions in ambiguous situations.
  • Exhibits a sense of urgency when addressing problems in keeping with PAREXEL’s High
Performance Culture.
  • Culturally aware and ability to think and work globally; ability to lead a ‘virtual’ and global team, which may include travel across PAREXEL facilities worldwide.
  • Intermediate desktop software skills (MS Office, Excel, Visio, Adobe PDF etc.).
Knowledge and Experience:
  • Clinical trials and /or research work experience a must, 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.
Education:
  • Educated to degree level (technology, biological science, pharmacy or other health related discipline preferred) or equivalent qualification, or 8+ 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.
Skills:
  • Subject Matter Expert (SME) 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 including a strong focus on key performance indicators.
  • Excellent interpersonal, verbal and written communication skills, business understanding, negotiation skills and strong organizational skills.
  • Ability to work in a customer-focused, fast-paced and rapidly changing environment with the ability to prioritize workload and manage multiple and varied tasks with enthusiasm.
  • Highly motivated, seeks opportunities for development, client-focused, and has the ability to work unsupervised and on own initiative, which includes making appropriate decisions in ambiguous situations.
  • Exhibits a sense of urgency when addressing problems in keeping with PAREXEL’s High
Performance Culture.
  • Culturally aware and ability to think and work globally; ability to lead a ‘virtual’ and global team, which may include travel across PAREXEL facilities worldwide.
  • Intermediate desktop software skills (MS Office, Excel, Visio, Adobe PDF etc.).
Knowledge and Experience:
  • Clinical trials and /or research work experience a must, 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.
Education:
  • Educated to degree level (technology, biological science, pharmacy or other health related discipline preferred) or equivalent qualification, or 8+ 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.

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