Job Title - Microbial and Viral Platform (MVP) QC/AS Head
Location - Hangzhou, Zhejiang, China
WuXi Biologics is a is a leading global open-access biologics technology platform offering end-to-end solutions to empower organizations to discover, develop, and manufacture biologics from concept to commercial manufacturing. WuXi Biologics’ achievements are a direct result of the efforts made by our employees. We have built an extraordinary team motivated by our PROUD culture of Passion, Reward, Opportunity, Unity and Determination. WuXi Biologics offers exciting job opportunities and careers around the globe. We currently employ over 12,000 people and provide services to more than 600 customers worldwide, including all the top 20 biopharmaceutical companies.
We are seeking a dynamic and experienced professional to fill the role of Head of Quality Control. The successful candidate will develop, implement, and periodically evaluate a program to ensure the organizations production operations, from raw materials to finished products, meet the quality, integrity, and efficiency standards set by the organization. The position involves collaborating closely with internal teams, global sites, and external clients to support manufacturing activities from early-phase through commercialization.
Responsibilities:
- Oversee an organization of eighty scientists, lead QC operation according to the manufacturing project plan, quality systems, and regulatory requirements. Ensure the effective delivery of the QC part of the project goals with high quality, well documented, and on time.
- Develop QC function policies and procedures with the alignment of the global quality team and regulatory requirements, with a concentrated focus on facility utilities, raw materials, in-process testing, and final drug product testing. Drive site-defined operational excellence methodologies throughout QC operations to meet quality and efficiency targets.
- Actively work with senior leadership team to resolve the operation issues and enhance the site quality/efficiency and collaboration across departments.
- Approves major documents in support of regulatory submissions and represent the QC operations during Health Authority inspections.
- Uses scientific expertise to provide guidance on troubleshooting, laboratory investigations and problem resolution
- Provide testing CoA/Batch record and stability data for regulatory filing, draft and review of relevant CMC sections for regulatory submissions
- Manage and support staff from technical and regulatory perspectives in the execution of testing, ensure compliance, and handle deviations, investigations, and CAPA.
- Support internal and external audits and regulatory inspections
- Responsible for QC budget drafting, and maintaining QC operating costs within budget
- Recruit, train, and retain a high-performance QC team. Directs the laboratory staff, sets goals for group leaders, establishes performance objectives for the department, and maintains efficient utilization of resources. Coaches and develops team by providing an environment that encourages ongoing personal and professional development.
- Conduct effective communication internally and externally to ensure alignment between WuXi Biologics and clients
Qualifications:
- Ph.D. or M.S in Biology, Chemistry, Micrology or related biotechnology discipline with a minimum of 15 years of experience in biopharmaceutical or biotech industry
- Prior leadership experience required
- Extensive knowledge in analytical and QC operations in the development and commercializing bio-therapeutics.
- Understand current regulations and industry trends of biologics product development, characterization, and manufacturing testing requirements including cGMP, ICH, EMA, FDA, and other global regulations and guidance.
- Strong technical background in assay development, pharmaceutical analysis, bioassay, impurity testing, microbiology support, quality control, and stability management. Experience in mass spectrometry is a plus.
- Experiences in raw materials release, environmental monitoring, biosafety, and cell bank testing.
- Hands-on experience in biopharmaceutical testing such as CE, HPLC, qPCR, ELISA, or Microbiology testing is preferred.
- Set method transfer and validation strategies, support DS/DP Specification setting
- Skillful in stability study programs for drug products and participating in regulatory filing and query responses to regulatory authorities.
- Knowledge of equipment and instrument qualification and validation.
- Experiences in new technology implementation
- Familiar with data integrity strategic plan, experiences in building and implementing QC LIMS system, and analytical instrument software validation.
WuXi Biologics is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.