QC Director

Job Summary: We are seeking an accomplished and strategic Quality Control (QC) leader to establish and oversee all QC operations for WuXi STA’s new DE site. The QC Director will lead all Quality Control functions for WuXi STA's new drug product manufacturing site, including QC Analytical, QC Microbiology, and QC Operations. This role is responsible for establishing and maintaining GMP-compliant laboratory operations to support the release and stability testing of drug products, raw materials, and packaging components, as well as providing QC support for process and cleaning validation activities. During site startup, the QC Director will oversee lab buildout, equipment qualification, method transfers, staff recruitment, and quality system implementation. In steady-state, the QC Director will ensure all QC activities meet regulatory requirements and client expectations, while driving continuous improvement and inspection readiness.

Responsibilities

QC Program Leadership

• Provide strategic leadership for QC Analytical, QC Microbiology, and QC Operations teams, ensuring alignment with corporate and site objectives.
• Develop and implement QC startup plans, including staffing, training, SOP creation, method transfers, and deployment of quality systems.
• Oversee laboratory design input, layout optimization, and equipment selection, procurement, installation, and qualification (IQ/OQ/PQ) for analytical, microbiology, and support laboratories.
• Ensure QC laboratories, workflows, and processes meet cGMP requirements and global regulatory standards (FDA, EMA, ICH, USP, EP, JP).
• Coordinate QC support for technology transfers, drug product manufacturing, process validations, cleaning validations, and operational readiness activities.
  
  

Regulatory Compliance

• Ensure all QC activities are executed in compliance with cGMP, FDA, EMA, ICH, USP, EP, JP, and other applicable guidelines.
• Maintain inspection readiness at all times; prepare for and lead client, regulatory, and internal inspections, ensuring timely and effective follow-up on findings.
• Oversee implementation and maintenance of QC documentation systems, data integrity programs (ALCOA ), and compliance archives.
• Lead QC participation in internal and external audits, ensuring prompt closure of observations and CAPAs.
  
  

Operational Management

• Manage QC budgets, staffing, and resource allocation to meet project, operational, and client timelines.
• Oversee execution of batch release testing, stability programs, environmental monitoring, method validations, and method transfers.
• Lead or approve deviation investigations, root cause analyses, and CAPA implementation for QC-related issues, ensuring timely closure.
• Foster a culture of quality, safety, continuous improvement, and cross-functional collaboration with Manufacturing, QA, Engineering, and Supply Chain.
  
  

Technical Leadership

• Serve as subject matter expert (SME) for QC operations, laboratory systems, analytical and microbiological testing methods, and regulatory compliance requirements.
• Provide QC input into new product introductions, client onboarding, and lifecycle management activities.
• Monitor industry trends, regulatory updates, and emerging technologies to identify opportunities for improving QC efficiency, capacity, and quality.
• Sponsor and lead implementation of process improvements, automation, and digital solutions within QC.
  
  

People Management & Leadership

• Build, develop, and retain a high-performing QC team across Analytical, Microbiology, and Operations functions.
• Define organizational structure, roles, and career paths to support both site startup and long-term operations.
• Set clear goals and performance expectations, conducting regular feedback, coaching, and performance reviews.
• Foster a culture of accountability, teamwork, continuous learning, and employee engagement.
• Lead by example in demonstrating quality mindset, compliance, and commitment to client satisfaction.
  
  

Qualifications

• PhD in Chemistry, Microbiology, Chemical Engineering or related field preferred; master’s or bachelor’s degree with extensive relevant experience will also be considered.
• Minimum of 10 years of progressive QC leadership experience in GMP-regulated pharmaceutical or CDMO environments.
• Proven experience in building or expanding QC operations during site startup or major expansions.
• Strong knowledge of FDA, EMA, and ICH guidelines and global regulatory expectations.
• Excellent leadership, communication, and client-facing skills.
  
  

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 based on disability

This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. Employees holding this position will be required to perform any other job-related duties as requested by Management.