Quality Assurance Manager

APICES is a CRO in the pharmaceutical sector. It offers services in the field of clinical research both nationally and internationally providing support in the development of research projects.

The ideal candidate is a critical thinker who will proactively will be responsible for the maintenance of the APICES quality system and will lead Good Clinical Practice compliance audits including, but not limited to, clinical research sites, service providers and internal systems and processes. In addition, this position is responsible for preparing for inspections by regulatory agencies and will also participate in process improvement programs, and interaction with key partners to obtain constructive feedback.

Responsibilities

• Identify potential risks before they become a problem, focusing on root cause analysis and preventive action
• Build a strong team through coaching, mentoring, specific training and performance evaluations
• Writes and develops of quality documents to maintain up to date quality systems which meet the applicable SOPs.
• Reports and follows-up on any quality deviations/non-conformities.
• Coordinates training program within the company.
• Management, coordination and participation in regulatory authority inspections.
• Management, coordination and performance internal and external audits according to audit plan and SOPs.
• Prepare audit reports and CAPA plans.
• Check that planned activities have been carried out and thus ensure compliance with the quality system of each department.
• Identifies training requirements and prepares and develops an adequate training plan.
• Provides SOPs and QA training.
• Maintains global consistency of compliance programs and advice to all the departments.
• Ensures SOP compliance elaborating the tools for an adequate follow up.
• Reviews Project/Study Plans, Clinical Study Reports, Data Management Plans, Informed Consent Forms and any other relevant research-related documents for accuracy and compliance.

Experience

• Knowledge and previous experience in clinical research and CRO environment
• GCP and GxP
• Quality assurance activities and ISO 9001:2015.

Qualifications

• Bachelor's degree or equivalent experience in Health Sciences
• 4+ years' relevant work experience
• Highly organized with excellent attention to detail
• English