Ensure all projects with CMOs, warehouses, and commercial teams in APAC comply with regulatory requirements and industry standards
Manage daily quality activities for CMOs, including validation, manufacturing processes, documentation, batch reviews, and product releases
Monitor CMO performance using quality metrics, address issues promptly, and collaborate with stakeholders for resolution
Assist in regional product development by supporting validation processes, equipment qualifications, and manufacturing improvements at CMOs
Lead or participate in audits (CMO, third-party, and customer) and ensure follow-ups and corrective actions are completed
Oversee new product introductions with CMOs, including change controls, production line validations, documentation reviews, and label claims
Act as a communication link between CMOs and internal teams to address customer-specific requests, resolve complaints, and manage deviations
Drive root cause analysis, CAPA and implement changes as needed
Serve as the primary contact for regional HH quality matters, bridging regional teams, global quality teams, and other key stakeholders
Work with product development scientists, CMO teams, regulatory affairs, and local authorities to support quality and compliance efforts
Collaborate with the global HH complaint coordinator and the PPD&A team to ensure smooth new product introductions.
Requirements
MSc degree or equivalent in a science-related field
At least 5 years of experience in the Biotech, Pharma, or Food industry
Preferably in a quality role with cross-functional collaboration
Knowledge of dietary supplements
Experience in CMO management
Experience with Blue Hat product registration is a plus
Experience with standards and regulations like Eudralex Vol. IV, HACCP, FSSC 22000, 21 CFR part 117 & 111, and Chinese GB standards for food and additives
High level of integrity and strong drive for performance and career development
Excellent written and verbal communication skills in both English and Chinese.
Benefits
At Novonesis we commit to an inclusive recruitment process and equality of opportunity for all our job applicants
We recommend you not to attach a cover letter to your application
Instead, please include a few sentences in your resume/CV about why you are applying
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Novonesis is committed to creating a diverse environment and is proud to be an equal opportunity and affirmative action employer.
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