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Quality Assurance Manager
2 weeks ago
Job Title: Senior Quality Assurance Manager
Job DescriptionThe Senior Quality Assurance Manager plays a critical role in ensuring the company's adherence to policies, study protocols, and regulatory requirements. This position requires expertise in quality assurance, risk management, and regulatory compliance.
- Develop and implement strategic audit plans to proactively identify areas of concern and ensure regulatory compliance.
- Lead comprehensive quality audits in accordance with regulations and standards governing clinical research to assess adherence to regulatory standards and company policies.
- Provide expert consultation on GxP requirements and quality assurance strategies, guiding both internal and external stakeholders.
- Coordinate and conduct clinical sites audits in collaboration with project management teams, ensuring efficient and effective audit execution.
- Education: At least an Honor's Bachelor's degree.
- Experience: A minimum of 7-9 years in quality auditing functions within a contract research organization (CRO), pharmaceutical, biotechnology, or related organizations.
- Strong understanding of research ethics and privacy, as well as previous experience leading a team is required.
- Certified Auditor (ASQ, ISO, or equivalent): Strongly preferred.
- Expertise in Regulations: Advanced technical knowledge in global regulations and industry standards applicable to clinical research, medical devices, and pharmaceuticals.
- Competitive salary range: $86,500 - $144,000 per year.
- Additional benefits include a bonus and remote work options.
Excellent verbal and written communication skills are required, including the ability to plan, organize, prioritize, and manage workload independently.
Ability to adapt quickly to changing environments, think critically, and learn new tasks by applying routine knowledge.
