The Opportunity

The CQA Manager is a global role managing Global CQA activities in the respective regions (Asia-Pacific, Americas, EMEA, Japan) and globally. Under guidance of the Head CQA Operations in the respective region, you will be responsible for planning, maintenance, and implementation of the assigned Global R&D Quality Audit Program with focus on Clinical Development (from early First in Human to late clinical phases) in your region.

Under guidance of the Head CQA Operations in the respective geographical region, you are responsible for the execution and performance of the Global CQA Quality System elements in the assigned compliance area including Management of CAPAs and Deviations, Inspection Preparation and Management, Change Management, Continuous Improvement, Compliance, Governance and Reporting, 3rd Party management, Regulatory Intelligence, Clinical IT Systems and Procedural Quality Assurance.

• Develop the assigned Project or Compliance Area Audit Program/s.
• Perform risk assessments, input of information and tracking progress of the assigned Audit Program
• Coordination with clinical development and operational responsibilities to provide a current CQA risk-based audit program, including update of specific risk matrices in the assigned compliance areas.

• Performance of self-inspections/audits of internal processes/ procedures, clinical investigator sites, clinical databases, study reports, contract CROs/vendors, and/or Independent Ethics Committees/ Institutional Review Boards to assess the accuracy and quality of scientific data and/or ensure compliance with relevant guidelines, legal requirements and GXPs.
• Development, review and issuance of Audit Reports outlining the findings categorized according to level of risk/s and CAPA recommendations.
• Approve CAPA plans resulting from audits and inspections.
• Manage individual CAPAs resulting from audits and inspections to ensure issues are thoroughly evaluated (including a risk assessment, root cause analysis and effectiveness measures) and identified actions are addressed and closed promptly.
• Directly follow-up on observations resulting from audits of 3rd party vendors and oversee timely CAPA resolution Identify non-compliance trends and systematic risks for assigned areas of responsibilities.
• Escalate non-compliances/ trends to Line manager/ Head, Global CQA.

• Provide GCP and process related support.
• Perform GCP review of new/ updated GxP relevant procedural documents, as assigned.

• Preferred: University degree (MSc/Diploma) in Scientific Discipline/ Life Sciences or other related disciplines.
• Minimum of 5 years of professional work experience in clinical research in the Pharmaceutical Industry, minimum 4 years' experience in a Quality Assurance or Compliance function globally operating.
• Work unassisted and as a team player when working in a group.
• Work unassisted and as a team member.
• Conduct audits unassisted and/or as part of a team.
• In-depth knowledge of industry regulations and clinical development processes with emphasis on local and international standards and regulations and associated GxP guidelines.
• Experience in a management role is desirable.
• Experience working in a Quality related and/or Process Management related environment /role.
• Strategic development and analytical skills .
• Experience managing processes with a continuous improvement approach.
• Analyze complex circumstances and problems, and to guide appropriate actions.
• Experience in resource and budget management
• Work and collaborate at all levels within an organization.
• Domestic (and International Travel, as assigned) required.