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Roche

Global pharmaceuticals and diagnostics company

Manufacturing Quality Assurance Associate Manager

Validation, Compliance & Quality SystemsConfirmed live in the last 24 hours
Full-timeShanghai, ChinaNo salary listedIn-person

About the Job

Requirements

  • A four-year bachelor's degree in Pharmacy, Pharmaceutical, Bioengineering, Chemistry, or an equivalent education level is required.
  • Good understanding of Good Manufacturing Practice (GMP) and the ability to implement it.
  • Knowledge and experience in production and quality management are required.
  • Good verbal and written communication skills in English are required.

Responsibilities

  • Collaborate with manufacturing operations, supplier quality, quality systems, and planning to provide end-to-end quality oversight throughout the lifecycle of repackaged products and investigational medicinal products (IMPs), including quality activities in warehouse operations and packaging plants.
  • Manage and oversee frontline quality assurance activities for repackaged products and IMPs in plants.
  • Manage the sampling process for repackaged products.
  • Oversee specifications, process monitoring, product monitoring, and stability programs for repackaged products.
  • Connect with global functions and serve as a quality representative across repackaged-product lifecycle management.
  • Execute frontline quality assurance activities in plants and warehouses.
  • Monitor live production status against the production schedule, follow up on deviations, identify potential risks, and take preventive action.
  • Attend production, warehouse, and other tier meetings.
  • Review batch records and support real-time problem-solving with production and warehouse teams.
  • Implement batch-release processes for repackaged products and additional labeling of IMPs, and ensure batch documentation is reviewed on time according to Roche timelines.
  • Ensure commercial products are not sold or supplied before release by a Qualified Person or Authorized Person, and that production batches meet marketing authorization and other applicable regulatory requirements.
  • Release batches of relabeled IMPs.
  • Ensure timely disposition of direct-material batches according to Roche requirements.
  • Oversee material quality, including specifications, artwork, SAP/MES master data, change management, document management systems and corrective and preventive actions, new-material qualification, and quality management.
  • Support local supplier quality management, including audits and quality agreements.
  • Check shipping documents for clinical-trial materials and perform system release.
  • Evaluate transportation temperature excursions for locally sourced IMPs.
  • Support investigations of repackaged-product and IMP complaints.
  • Manage events and corrective and preventive actions using root-cause analysis tools; facilitate discrepancy investigations across departments, ensure they are completed on time, and support product release.
  • Collaborate with subject-matter experts and lead investigators to develop investigation strategies.
  • Participate in the Local Quality Council as needed.
  • Monitor investigation progress and ensure effective corrective and preventive actions are initiated and completed on time, supporting continuous improvement.
  • Investigate customer complaints and work with relevant departments to ensure effective corrective and preventive actions are initiated and completed on time.
  • Maintain QA processes and documentation in a continuously compliant state and ready for regulatory inspections.
  • Manage site material quality, repackaging of finished products, and labeling of donation products.
  • Support drafting and review of local Annual Product Quality Reviews.
  • Support inspections by health authorities and Roche Global.
  • Participate in quality-related projects and manage documentation.
  • Complete other tasks assigned by senior leaders.

Desired Qualifications

  • A graduate or higher-level degree is preferred.

About the Company

Roche

Global pharmaceuticals and diagnostics company

Roche is a global leader in pharmaceuticals and diagnostics. It develops medicines and diagnostic tools that help detect, monitor, and treat diseases, using research and biotechnology to drive new therapies and tests. Roche combines drug development with in-house diagnostic products to support personalized medicine, where treatments are tailored to individual patients based on test results. Its approach differs from many peers by integrating drug discovery with diagnostic capabilities and by expanding its research through strategic acquisitions (like Genentech) to strengthen its biotechnology and R&D capabilities. The company’s goal is to improve patient outcomes and healthcare worldwide by delivering reliable medicines, accurate diagnostic tests, and data-driven care.

Company size
1-10
Company stage
IPO
Headquarters
Basel, Switzerland
Founded
1896

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