Quality Assurance Manager

at  Humanwell Pharmaceutical US Inc

SUMMARY

Humanwell Pharmaceutical US, Inc. is a St Louis, MO-based pharmaceutical research and development company that focuses on research and development of novel therapeutics to address unmet medical needs. At Humanwell, we work towards improving patients’ quality of life and are committed to creating a healthier world of tomorrow.
The Quality Assurance Manager plays a pivotal role in implementing and overseeing GMP quality management systems. This position involves handling diverse and complex tasks to ensure quality and compliance with regulatory requirements and guidances. Responsibilities include document review, audits, inspections, consultation on quality and compliance matters, data reviews, validation projects, and training.

REQUIRED QUALIFICATIONS AND SKILLS:

• Undergraduate or above degree in a chemistry, biology or related field
• 5+ years of Quality Assurance experience in the pharmaceutical or related industry
• In-depth knowledge of cGMP Regulations
• Proven experience in implementing and managing quality management systems
• Experienced GMP Auditor
• Knowledge of QC analytical techniques is preferred
  Job Code: HM-049
  Department: Formulation and Product Development
  Report to: Department head
  At Humanwell, all our employees are part of a team that cares about them. We offer a competitive salary and benefits package, including health insurance, 401K, and vacation plan. Our company is committed to diversity and inclusion, and we welcome candidates of all backgrounds to apply. We hope that you seek to join us on our journey as we develop medicine and improve global human well-being.
  Apply: Interested candidate, please apply through: https://www.humanwellus.com

• Develop and implement quality assurance policies and procedures in accordance with FDA, ICH, and cGMP requirements, and adapt them to align with regulatory changes. Create or revise SOPs as needed.
• Review and provide quality approval of study-related documentation, including batch records, protocols, reports, CoAs, and methods.
• Evaluate and approve quality events, such as deviations, OOS investigations, change controls, and CAPA.
• Conduct quality inspections to ensure adherence to industry standards and regulations.
• Participate in projects to ensure proper validation and qualification of facilities, utilities, and equipment.
• Maintain accurate quality assurance files, records, and databases.
• Support site inspection readiness