Quality Assurance Manager

About the role

ClinSoft LLC, a biometrics and technology company providing end-to-end clinical study support to pharmaceutical and biotechnology organisations, is hiring a full-time, office-based Quality Assurance Manager. The role is not a technical QA position and candidates currently employed elsewhere will not be considered. The manager maintains and improves the company's Quality Management System in line with ISO 9001, GxP requirements, contractual obligations and internal procedures, and provides independent quality oversight of regulated activities to protect participant safety, ensure reliable study results, data integrity and consistent service delivery.

Key responsibilities

• Quality planning and risk management, controlled-document review, internal audits, supplier qualification, external audit and inspection support, deviation and CAPA management, change control and training oversight.
• Coordinate quality objectives with management and process owners, monitor quality performance, provide inputs to management review and escalate significant quality or compliance issues.
• Promote a process-based, risk-based approach and ensure quality decisions, reviews and approvals are documented with independence and traceability.

Required profile

• University degree in Life Sciences, Pharmacy, Biotechnology, Healthcare or another relevant discipline.
• At least five years of quality assurance or quality management experience in a CRO, pharmaceutical, biotechnology, healthcare or comparable GxP-regulated organisation, including coordinating quality activities and leading audits or improvement initiatives.
• Documented GCP training with a certificate, with updates kept up to date.
• Preferred: GxP, GMP, Quality Management, Quality Auditing and Quality Control skills, and familiarity with clinical research, biometrics or healthcare technology.

Required skills

• Practical knowledge of GxP requirements, including ICH Good Clinical Practice.
• Working knowledge of ISO 9001, including internal audits, management review and corrective action.
• Auditing competence: planning and conducting audits, documenting findings and following corrective actions through to verification.
• Document control, deviations, root-cause analysis, CAPA, change control, supplier qualification and quality risk assessment.
• Data integrity understanding and computerized system lifecycle controls, risk-based validation, electronic records, access controls and audit trails.
• Ability to write clear procedures, audit reports and quality summaries, and to work with international teams.