Expecto Health Science
Website:
expectohealthscience.com
Job details:
Company Description Expecto Health Science (Southern Star Research Company) is a leading Clinical Research Organization headquartered in Singapore, providing comprehensive and cost-effective services across the Asia Pacific region. The organization specializes in Clinical Development, Data Management, Medical Writing, Regulatory affairs, and Pharmacovigilance, offering tailored solutions to diverse clients. Expecto Health Science is known for its Functional Service Provider (FSP) model, delivering strategic resourcing options to regional and global pharmaceutical partners in a cost-efficient manner. Its client portfolio includes innovators of new chemical entities and biologicals in early clinical development, small to mid-sized pharmaceutical and biotechnology firms with niche products, and medical device companies.
Role Description The Head of Quality Assurance – Clinical Research is a full-time, on-site role based in Navi Mumbai. This role is responsible for leading the QA function, designing and implementing quality systems and standards across clinical research operations, and ensuring compliance with regulatory and GCP guidelines. Daily activities include overseeing internal and external audits, managing quality control processes, reviewing and approving SOPs, and driving continuous improvement initiatives in quality management. The role also involves collaborating with clinical, data management, regulatory, and pharmacovigilance teams to resolve quality issues, providing training on QA procedures, and reporting quality metrics and risks to senior leadership. The Head of QA will mentor QA staff, support client and regulatory inspections, and contribute to strategic planning for quality practices within the organization.
Qualifications
- Candidates should possess strong Quality Assurance and Quality Management skills, with experience establishing and maintaining robust QA frameworks in clinical research.
- Candidates should possess expertise in Quality Control and Quality Auditing, including planning and conducting audits, implementing corrective and preventive actions, and ensuring process adherence.
- Candidates should possess solid Analytical Skills to interpret quality data, identify trends and risks, and recommend evidence-based improvements to systems and procedures.
- Extensive knowledge of GCP, ICH guidelines, and applicable regulatory requirements for clinical trials in the Asia Pacific region.
- Demonstrated leadership experience managing QA teams in a CRO, pharmaceutical, or biotechnology environment, with strong stakeholder management capabilities.
- Excellent written and verbal communication skills, and the ability to present complex quality findings clearly to internal teams and clients.
- Relevant academic background such as a degree in Life Sciences, Pharmacy, Medicine, or a related field; advanced qualifications or certifications in quality or clinical research are an advantage.
- Proven experience handling regulatory inspections, client audits, and implementing continuous quality improvement initiatives.
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