Quality Assurance Manager
Salary undisclosed
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Role Overview:
We are looking for an experienced GMP Quality Manager to lead our Quality Assurance function. This is a key role responsible for ensuring GMP compliance, overseeing quality systems, and managing CDMO quality activities within a global framework.
Key Responsibilities:
- Quality Leadership: Lead GMP quality assurance functions and drive compliance with US FDA GMP, EMA, NMPA, and ICH guidelines.
- Quality Systems Oversight: Implement and maintain robust quality management systems in alignment with regulatory requirements.
- CDMO Management: Oversee quality activities at Contract Development and Manufacturing Organizations (CDMOs) and manage Quality Agreements.
- Regulatory Compliance: Ensure adherence to global GMP standards, providing strategic quality guidance and leading regulatory inspections.
- Audit & Risk Management: Conduct internal and external audits, develop CAPAs, and drive continuous quality improvements.
- Documentation & Training: Maintain high-quality documentation and lead GMP training programs across departments.
Requirements:
- Fluency in Mandarin (both written and spoken) is required.
- BSc in Life Sciences or a related field; advanced degrees preferred.
- 8+ years of quality experience in the pharmaceutical or biotechnology industry.
- Proven leadership experience in GMP QA functions within a global organization.
- Strong regulatory expertise in US FDA GMP, EMA, NMPA, and ICH guidelines.
- CDMO oversight experience and a track record of managing Quality Agreements.
- Knowledge in clinical development to commercial is desired
- Knowledge of cGMP requirements as they pertain to Quality Control testing.
- Experience with electronic Quality Management Systems (eQMS)
- Experience in support client or regulatory audits. High-level interactions with domestic and international Regulatory agencies is desirable
- Knowledge of CMC analytical and regulatory requirements
- Experience with Viral Vectors is highly preferred
Role Overview:
We are looking for an experienced GMP Quality Manager to lead our Quality Assurance function. This is a key role responsible for ensuring GMP compliance, overseeing quality systems, and managing CDMO quality activities within a global framework.
Key Responsibilities:
- Quality Leadership: Lead GMP quality assurance functions and drive compliance with US FDA GMP, EMA, NMPA, and ICH guidelines.
- Quality Systems Oversight: Implement and maintain robust quality management systems in alignment with regulatory requirements.
- CDMO Management: Oversee quality activities at Contract Development and Manufacturing Organizations (CDMOs) and manage Quality Agreements.
- Regulatory Compliance: Ensure adherence to global GMP standards, providing strategic quality guidance and leading regulatory inspections.
- Audit & Risk Management: Conduct internal and external audits, develop CAPAs, and drive continuous quality improvements.
- Documentation & Training: Maintain high-quality documentation and lead GMP training programs across departments.
Requirements:
- Fluency in Mandarin (both written and spoken) is required.
- BSc in Life Sciences or a related field; advanced degrees preferred.
- 8+ years of quality experience in the pharmaceutical or biotechnology industry.
- Proven leadership experience in GMP QA functions within a global organization.
- Strong regulatory expertise in US FDA GMP, EMA, NMPA, and ICH guidelines.
- CDMO oversight experience and a track record of managing Quality Agreements.
- Knowledge in clinical development to commercial is desired
- Knowledge of cGMP requirements as they pertain to Quality Control testing.
- Experience with electronic Quality Management Systems (eQMS)
- Experience in support client or regulatory audits. High-level interactions with domestic and international Regulatory agencies is desirable
- Knowledge of CMC analytical and regulatory requirements
- Experience with Viral Vectors is highly preferred