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Roche is seeking a Head of Quality Assurance for their new biologics facility in Shanghai, China. The ideal candidate will have extensive experience in GMP compliance and quality assurance within the pharmaceutical or biotechnology sectors, with a strong emphasis on leadership and team development.
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Job Summary
This role provides leadership and technical support for all GMP/quality activities in a new biologic aseptic filling site.
The successful candidate will oversee batch release processes, manage quality events, and act as the primary authority on GMP compliance.
Roche fosters a culture of personal expression and open dialogue where every voice matters to prevent, stop, and cure diseases.
Matching Summary
Match Score: 75
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Roche is seeking a Head of Quality Assurance for their new biologics facility in Shanghai, China. The ideal candidate will have extensive experience in GMP compliance and quality assurance within the pharmaceutical or biotechnology sectors, with a strong emphasis on leadership and team development.
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Skills & Requirements
Must-have
10 years pharmaceutical QA experience
5 years supervisory leadership role
FDA/EU cGMP and ICH guidelines knowledge
New facility startup and ramp-up experience
Batch record review and product release oversight
Change control and deviation management expertise
Nice-to-have
Auditor or QP training certification
Experience with SAP, Veeva, or Orca tools
Strong stakeholder management skills
Fluent English communication abilities
Lean principles and continuous improvement mindset
Key Requirements
Degree in pharmaceutical sciences or related discipline
Minimum 10 years experience in QA/GMP operations
Minimum 5 years in a supervisory position
Proven experience with international regulatory networks
Demonstrated ability to lead cross-functional teams