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WD144254 - Director of Quality and Risk Management

Job Details

  • Permanent, Full Time
  • Greater London
  • Closes 20th December 2017
  • Requisition ID: WD144254
  • Required degrees: Bachelors
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Basic qualifications:

BS or equivalent.
Experience in pharmaceutical/biologics regulatory, quality or scientific disciplines.
• Broad-based pharmaceutical experience with extensive understanding of the quality environment and compliance related expectations and processes; extensive knowledge of drug development and R&D – its strategy, objectives, customers, business units, processes and culture; demonstrated solid working understanding of strictly regulated environment.
• Proven understanding of quality management and assurance principles. Understanding of regulatory affairs, drug development and lifecycle maintenance activities. Demonstrated experience and capability in managing risk and risk treatment plans.
• Track record of managing and delivering projects, particularly in the areas of quality and compliance.

Preferred qualifications:
• Practical experience leading and implementing process development and improvement activities that embed quality and drive continuous improvement. Experience in process mapping and writing process documents.
• Flexible approach, readily adapting to changing circumstances and new opportunities; encourages, leads, facilitates and drives change where appropriate. Challenges and questions ways of working to seek improved processes.
• Excellent attention to detail. Able to rapidly assimilate, interrogate and understand complex data, and formulate risk-based, pragmatic quality driven solutions.
• Operates with independence, effectively communicating at all levels.
• Promotes a culture of trust and openness where colleagues and stakeholders are encouraged to openly contribute.
• Strong influencing and change management skills.

Develop and maintain an integrated quality and risk management program within GRA that:

• Embeds quality, risk management, and continuous improvement principles. Promotes development and sustainability of a continuous improvement quality culture framework and standards within GRA.
• Ensures appropriate and robust quality controls are in place and in use. Supports GRA in self-identifying quality issues and in managing/creating robust solutions. Ensures effective investigations and root cause analyses of issues are completed and appropriate Corrective and Preventive Actions are identified and implemented.
• Facilitates the conduct of Risk Assessments and the development of Risk Mitigation Plans, and monitors mitigation actions.
• Ensures delivery and embedding of corporate and R&D driven quality and compliance initiatives, in GRA.
• Facilitates inspection and audit readiness in GRA. Partners with Global Quality Assurance to support regulatory authority inspections as required within GRA.

Contact information:
You may apply for this position online by selecting the Apply now button.

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