? [3 Days Left] Senior Quality Assurance Specialist

Key Responsibilities: - Collaborate with the Clinical Affairs team to ensure compliance during trial activities, such as resolving deviations and complaints.
- Represent Clinical QA as part of project teams for planned and ongoing clinical trials, including quality review of trial-related documentation.
- Support the qualification process and perform independent QA audits of clinical study sites.
- Participate in the internal audit program.
- Review and update Clinical Affairs SOPs.
Position Requirements: - Degree qualification in a relevant field or equivalent work experience.
- Proven experience and knowledge of clinical regulations, standards, guidelines, and best practices (e.g., CFR 812, BIMO, ISO standards, ICH GCP).
- Solid understanding of global In Vitro Diagnostic Regulations (e.g., EU IVDR, US 21CFR820).
- Ideally a qualified auditor with experience serving as a Subject Matter Expert during regulatory inspections and formal audits (e.g., NB audit).
- Willingness to travel internationally (up to 10%, including Europe and the US).
- Ability to work independently with good judgment and decision-making within established policies and practices.
- Strong communication and interpersonal skills, with the ability to work effectively in multinational and multicultural teams.