We are seeking a Quality Assurance Manager to oversee the GMP manufacture in house and Contract Manufacture or Suppliers, including review of executed batch records, approval of investigations, change controls and other associated quality documentation. Be able to work independently and professionally in the execution of the responsibilities. Be able to manage responsibilities in a fast-paced environment, meeting production objectives, while ensuring quality requirements are met.
Will be able to help design and develop QA policies, Quality system and procedures with quality leadership. This position will report directly to the Quality Head and may mange others.
- Develop and implement the Quality System at startup company
- Develop quality policy and SOPs
- Review and approve the cross functional SOPs
- Manage the deviations/CAPA/Control Change
- Manage the deviations/CAPA/Control
- Manage and maintain the metrics of quality system implementation and performance
- Provide training as needed
- Provide Quality “on the floor” Support
- Process qualification/validation, method qualification /validation and routine manufacturing and testing
- Support Technology Transfer and Cross-Functional Team
- Person in plant QA
- Material Release/Reject: Clinical & Commercial Batch Disposition
- Work with the manufacture or CMOs and QC or CTLs to insure timely receipt and resolution of batch documentation for GMP materials.
- Review batch-related documentation, and ensure proper resolution of quality issues prior to batch disposition.
- Review QC data and CoAs
- Ensure all product-related deviations are initiated, investigated and properly addressed to assure product quality.
- Ensure associated CAPA’s are initiated and resolved as needed.
- Review and approve change controls, as needed.
- Perform QA product disposition and lot closure.
- Ensure batch production files are organized and maintained.
- Authorize critical raw material and product shipments including release of material to clinical trial locations.
- Maintain metrics related to batch record review and product disposition in support of continuous improvement.
- Train, manage, coach and mentor staff as needed.
- Engage with partner staffs to improve the performance and compliance of their internal policies and procedures.
- Other duties as assigned.
- Bachelor’s degree or Master in related science or engineering field and minimum of 10 years of experience in GMP regulated biopharmaceutical manufacturing with preference for experience biologics products.
- Knowledge of quality systems and regulatory requirements including relevant US/EU guidelines.
- Minimum of 2 years of management experience.
- Direct experience with batch review and release of biologics product lots is preferred.
- Excellent communication skill including proficiency with both Chinese and English is required.
- Excellent writing and editing skills.
- Works on multiple assignments in collaboration with internal and external customers.
- Advanced computer skills with MS Office applications Word, Excel, PowerPoint, as well as Adobe Acrobat.