Hybrid Quality Assurance Manager

at Novonesis

• Job title: Quality Assurance Manager
• Job type: Full Time
• Experience level: Mid level, Senior
• Salary: Not specified
• Degree requirement: Postgraduate Degree
• Location requirements: Hybrid, Beijing, China

About the role

• Quality Assurance Manager ensuring compliance and quality management across CMOs in the biotech industry. Supporting product development, audits, and new product launches with a focus on regulatory adherence.

Responsibilities

• 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
• To ensure a fair recruitment process, please refrain from adding a photo in your resume/CV
• Novonesis is committed to creating a diverse environment and is proud to be an equal opportunity and affirmative action employer.