研发QA经理
Posted Updated
Description
- Provide end-to-end QA oversight across the entire product lifecycle, from early clinical development through late-stage clinical trials and NDA submission, for oral solid dosage products.
- Ensure that technology transfer, process scale-up, Investigational Medicinal Product (IMP) manufacturing, and registration-related activities are executed in full compliance with applicable GMP, Clinical GMP, and data integrity requirements.
- Provide QA oversight of manufacturing and quality control operations to ensure ongoing GMP compliance throughout clinical development.
- Ensure all QA activities related to clinical trial products comply with global regulatory requirements and internal quality standards.
- Support the establishment, maintenance, and continuous improvement of the site Quality Management System (QMS) in alignment with global QA strategies.
- Review and approve GMP- and quality-related documentation, including technology transfer packages, process development documentation, validation strategies, and change control records, ensuring phase-appropriate compliance.
- Lead or support the investigation and resolution of quality events, including deviations, OOS/OOT results, complaints, and CAPAs, arising during clinical manufacturing and testing.
- Partner closely with CMC and cross-functional teams to support clinical development activities, clinical supply readiness, and regulatory submissions (IND/CTA and NDA).
- Be responsible for the QA release of raw materials, packaging materials, intermediates, and finished drug products for clinical use.
- Oversee product lifecycle quality activities, including product complaints, recalls, Product Annual Review, and maintenance of Product Specification Files (PSF).
- Participate in and support external audits, health authority inspections, and regulatory interactions across clinical and registration stages.
- Participate in internal GMP self-inspections, ensuring timely follow-up and effective remediation actions.
Education: Bachelor or above degree in Pharmacy, Chemistry, or related. Master degree is preferred.
Experience: At least 8 years' experience in pharmaceutical industry, at least 5 years’ GMP experience; MNC/big pharma company working experience is preferred.
Technical skill:
Rich experience in GxP area of Quality and compliance management environment. Familiar with the requirements of China GMP, EU GMP and FDA cGMP, familiar with the Industry Guidelines, such as ICH, ISPE, etc.
Familiar with process and quality control of oral solid products. Experience Quality Management of Investigational Medicinal Product.
Familiar with CMC development and registration process of new drug during product lifecycle.
Soft skill:Continuously invest time and effort to gain new skills and knowledge required to succeed in the work.
Good communication skill. Show strong willingness to work closely with peers within and outside the team toward a common goal.
Leadership skill, provide clear direction and define priorities for the team and win the commitment of team members.
Language: Fluent spoken English
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