PRA Health Sciences

Manager of Quality Oversight

12 Jan 2021
11 Feb 2021
Full Time
Contract Type
Experience Level
Entry level

The Local Q&C Specialist is responsible for performing activities within the assigned country/countries that (1) ensure an integrated and comprehensive quality compliance approach for clinical trials in close collaboration with local and global quality functions, and (2) ensure clinical trials are performed in compliance with local laws and regulations, industry standards and global processes and procedures.

- Monitor compliance risk and ensure mitigation/remediation actions are defined

  • Monitor progress and confirm effectiveness of remediation plans, e.g. by performing QC checks or special investigations and plan, prepare, conduct and report QC checks and compliance assessments to ensure risk signals are addressed in a timely manner. More specifically perform the following risk based activities:

- Conduct On-Site Quality Monitoring Visits

- Perform assigned reviews of Trial Master File, training compliance documentation and other checks per QP&S - ----- Integrated Quality Plan for the trial

- Planning and execution of local QC checks

- Support and advise local and central study teams in root cause analysis of significant observations

- Ensure appropriate filing of the QC reports

- Support Quarterly Quality Reviews with local GCO management addressing compliance issues and risk signals

- Collaborate with local and central business partners to facilitate (local) inspections and office audits as needed

- Collaborate with local and central business partners in timely CAPA setting and implementation. Provide Quality - -- Event Management (QEM) CAPA Champion support. Moderate level of risk awareness and ability to translate risks into actions.

- Support the local impact assessment of global procedural documents and if applicable support development and management of associated local procedural documents

- Support onboarding of new hires

- Manage local workshops to support QMS and compliance awareness, Lessons Learned, etc

- Provide advice regarding SOP, system and GCP questions of moderate complexity

- Supports managing risk at the country level, including assessing root causes and developing effective actions to mitigate risk

- Perform impact assessments of new/revised local regulations, guidance and standards

- Support central functions in ensuring local intelligence is up to date (e.g., T- Race, IRON)

- Support LOC Management Review in collaboration with LOC Business Quality partners

- Support local vendor assessments as appropriate

- Support annual Due Diligence update, certification and training of local vendors, if applicable

A minimum of a Bachelor Degree in Science (BSc) or Arts (BA) or 4-6 years relevant experience equivalent is required. A minimum of 3 years of previous Pharmaceutical Industry experience is required, with at least 2 years of GxP experience within clinical research and development and/or quality assurance.

  • Knowledge of the overall drug development process
  • Developing or developed skills and knowledge of business processes and practices (i.e., SOPs governing clinical research activities)
  • Experience in quality assurance activities, including audits of clinical investigative sites, systems and vendors, and audits of regulatory submissions is an asset
  • Ability to translate data into information and strategies into executable action plans improving the business
  • Ability to motivate professional colleagues and stakeholders
  • Conflict resolution/management and negotiation skills
  • Ability to independently plan, organize, coordinate, manage and execute assigned tasks
  • Experience of the key customers’ business processes and practices
  • Good working knowledge of FDA/ICH and country-specific regulations and guidelines related to clinical development;
  • Experience with regulatory submissions (NDA, BLA) is an asset

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