Hybrid Quality Assurance Manager

Posted last week

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About the role

  • 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.

Job title

Quality Assurance Manager

Job type

Experience level

Mid levelSenior

Salary

Not specified

Degree requirement

Postgraduate Degree

Location requirements

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