Analyst in Quality Assurance supporting Quality Assurance activities within Information Technology at Fulton Bank. Collaborating with stakeholders to review requirements and assess the quality of solutions.
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.
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