What are the responsibilities and job description for the Compliance and Quality Leader CDMO position at WuXi AppTec?
This Compliance and Quality Leader CDMO role is responsible for leading the development, implementation, and maintenance of quality systems to ensure compliance with regulatory requirements. The ideal candidate will have a strong background in pharmaceutical quality assurance, with a proven track record of implementing quality systems and ensuring compliance with regulatory requirements.
About the Role
- Lead the quality assurance team in the development, implementation, and maintenance of quality systems to ensure compliance with regulatory requirements.
- Develop and implement strategies to improve quality and reduce risks associated with manufacturing processes.
- Collaborate with cross-functional teams to identify and address quality issues.
- Provide leadership and guidance to the quality assurance team to ensure they have the necessary skills and knowledge to perform their roles effectively.
Responsibilities:
- Manage a team of quality professionals and compliance consultants.
- Develop and implement resource plans for internal and external resources to support project plans.
- Recruit new staff and ensure they receive proper qualification and training.
- Coach, develop, monitor, and appraise direct reports.
Requirements:
- Bachelor's degree in Pharmaceutical, Chemical, or Analytical sciences, Master's and PE preferred or equivalent experience.
- Minimum 10 years of relevant experience in pharmaceutical quality assurance and/or facility and equipment qualification.
- Proven Quality leadership experience in a CDMO environment preferred.
- Proficient in pharmaceutical manufacturing processes (drug substance and drug product) and GMP regulations.
