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CSL - Kng Of Prussa, PA
posted 2 months ago
About the position
The CQA Manager is a global role responsible for managing Global CQA activities across various regions including Asia-Pacific, Americas, EMEA, and Japan. This position focuses on planning, maintaining, and implementing the Global R&D Quality Audit Program, particularly in Clinical Development phases. The role involves ensuring compliance with international guidelines and regulations, managing CAPAs and deviations, and supporting continuous improvement within clinical development and third-party vendors.
Responsibilities
- Develop the Global CQA Audit Program for assigned projects or compliance areas.
- Perform risk assessments and track progress of the assigned Audit Program.
- Conduct self-inspections/audits of internal processes, clinical sites, and vendors to ensure compliance with guidelines and legal requirements.
- Issue Audit Reports with findings and CAPA recommendations.
- Manage CAPAs resulting from audits and inspections, ensuring thorough evaluation and timely closure.
- Identify non-compliance trends and escalate to management as necessary.
- Analyze audit observations to support continuous improvement within Clinical Development and third-party vendors.
- Conduct pre-inspections and support regulatory agency inspections.
- Provide GCP and GxP consultancy to maintain compliance.
- Support the development of the Global R&D Quality System.
Requirements
- University degree (MSc/Diploma) in Scientific Discipline/Life Sciences or related fields.
- Minimum of 5 years of professional experience in clinical research within the Pharmaceutical Industry.
- At least 4 years of experience in a Quality Assurance or Compliance function.
- In-depth knowledge of industry regulations and clinical development processes.
- Experience in a management role is desirable.
- Strong strategic development and analytical skills.
- Experience in resource and budget management.
Nice-to-haves
- Experience working in a Quality related and/or Process Management related environment.
- Ability to analyze complex problems and guide appropriate actions.
Benefits
- Health care benefits effective from day 1 for employees working at least 30 hours per week.
- Financial protection resources.
- Support for family planning and emergency care.
- Mental health resources.
- Financial future planning support.
- Charity matching contributions.
