This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Senior Technology Auditor, QA based in India.
This role is an opportunity to support global quality assurance initiatives within a highly regulated environment focused on improving healthcare outcomes.
The Senior Technology Auditor, QA will lead and execute complex GxP audits, ensuring compliance with international standards, regulatory requirements, and quality frameworks.
The position requires strong expertise in auditing, clinical research, and quality systems while collaborating with global teams and stakeholders.
You will play a key role in identifying risks, driving process improvements, and strengthening operational excellence across quality programs.
Working in a dynamic, multicultural environment, you will contribute strategic insights and help maintain the highest standards of compliance and patient-focused research.
The role offers the opportunity to mentor others, influence quality practices, and support innovation across global clinical development activities.
This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Senior Technology Auditor, QA based in India.
This role is an opportunity to support global quality assurance initiatives within a highly regulated environment focused on improving healthcare outcomes.
The Senior Technology Auditor, QA will lead and execute complex GxP audits, ensuring compliance with international standards, regulatory requirements, and quality frameworks.
The position requires strong expertise in auditing, clinical research, and quality systems while collaborating with global teams and stakeholders.
You will play a key role in identifying risks, driving process improvements, and strengthening operational excellence across quality programs.
Working in a dynamic, multicultural environment, you will contribute strategic insights and help maintain the highest standards of compliance and patient-focused research.
The role offers the opportunity to mentor others, influence quality practices, and support innovation across global clinical development activities.
Accountabilities:
- Lead, plan, conduct, and report GxP audits across clinical research activities, including project audits, system and process audits, supplier audits, trial documentation reviews, and safety-related audits.
- Deliver high-quality audit reports within agreed timelines, identify improvement opportunities, and provide clear recommendations to strengthen quality processes.
- Manage audit findings by reviewing responses, monitoring corrective and preventive actions (CAPAs), and escalating risks when required.
- Coordinate internal and global audit programs by developing audit tools, tracking deliverables, analyzing trends, and reporting outcomes to quality leadership.
- Act as a quality advisor to internal teams and clients, providing guidance on regulatory expectations, compliance requirements, and effective quality practices.
- Support client audits and regulatory inspections by coordinating preparation activities and ensuring successful engagement with external stakeholders.
- Provide mentoring, training, and knowledge sharing to auditors and team members to strengthen audit capabilities.
- Maintain accurate quality records, audit documentation, and reporting systems while contributing to process optimization initiatives.
- Support investigations related to significant quality events and assist teams in determining appropriate corrective actions.
- Build strong relationships with global teams, clients, and operational stakeholders while promoting a culture of compliance, collaboration, and continuous improvement.
- Bachelor’s degree in technology, biological sciences, pharmacy, healthcare, or a related discipline, or equivalent professional experience.
- Minimum of 4 years of experience in quality assurance and auditing, including significant experience with GxP audits.
- At least 7 years of experience in clinical research, regulatory affairs, monitoring, data management, pharmacovigilance, laboratory operations, supplier management, or related life sciences fields.
- Strong knowledge and practical understanding of GxP standards, clinical trial regulations, and international quality requirements.
- Experience leading complex audits, preparing audit reports, managing findings, and supporting corrective action processes.
- Excellent analytical, problem-solving, organizational, and decision-making skills with strong attention to detail.
- Ability to manage multiple projects, prioritize workloads, and work effectively in a fast-paced global environment.
- Strong interpersonal and communication skills, including the ability to present findings, conduct training, and influence stakeholders.
- Experience working within multicultural and matrix organizations with multiple stakeholders.
- Proficiency with Microsoft Office tools and ability to quickly learn new systems and technologies.
- Willingness to travel internationally as required, with travel potentially reaching approximately 60%.
- Opportunity to contribute to global healthcare and clinical research initiatives that improve patient outcomes.
- Remote working flexibility with opportunities to collaborate with international teams.
- Professional growth through training, mentoring, and exposure to global quality assurance practices.
- Experience working with complex regulatory environments and industry-leading quality frameworks.
- Opportunity to develop leadership skills through audit ownership, mentoring, and cross-functional collaboration.
- Supportive and diverse workplace culture focused on teamwork, innovation, and continuous improvement.
- Competitive compensation and employee benefits package based on location and role eligibility.
The Senior Technology Auditor, QA is responsible for leading quality assurance activities, managing audit programs, providing regulatory guidance, and supporting continuous improvement initiatives across global operations. The role involves independent ownership of audits, stakeholder collaboration, and ensuring compliance with applicable quality standards.
Requirements:
The ideal candidate brings strong experience in quality assurance, auditing, and regulated clinical research environments, with the ability to operate independently while collaborating across global teams. A combination of technical expertise, analytical thinking, communication skills, and regulatory knowledge is essential.