Careers

Quality Assurance Manager

This role serves as the lead for QA Operations activities at the UBP Yangzhou plant including direct management of QA Specialist(s), the Quality Assurance Manager/ Sr. Manager/ Associate Director serves as the lead for a Quality Team that is responsible for QA oversight of deviations, change controls and CAPAs (Quality Systems) associated with biologics intermediate and drug substance manufacture.

You will support Quality Management oversight for intermediate and drug substance disposition and release responsibilities, develop strategic planning and implementation for YZ site Quality Assurance Management Systems to monitor policies, processes, procedures and controls ensuring that the quality of products manufactured at pilot and manufacturing plants conform to established standards and agency regulations.

 

Competencies:

  1. Demonstrates high level of involvement in continuous improvement of quality assurance philosophy and practices to ensure the highest standards are maintained
  2. Examines programs to create efficiencies in practices and optimal utilization of staff
  3. Utilizes strategic and critical thinking to anticipate the compliance needs of the organization while maintaining compliant operations on a day-to-day basis
  4. Focus on quality and compliance education within direct line management and outwards to all applicable site functions
  5. Understands cGMP’s and company procedures making sure cross functional compliance; when and if needed, to amend and revise procedures/ policies
  6. Understands, lead and ahere GMP regulations, cGMP’s, company policies, and leadership capabilities

Responsibilities:

  1. Quality oversight of quality system records (deviations, change controls and CAPAs)
  2. Partners with applicable groups and within Quality to develop solutions for moderate to complex problems
  3. Work on moderate to complex issues where analysis of situations or data requires an in-depth evaluation of variable factors
  4. Contribute to the development of new quality concepts, techniques, and standards o Provides direct support of regulatory agency site inspections including, but not limited to direct interactions with agency representatives Champion an environment of teamwork and collaboration
  5. Focus on skill building and enabling direct team to progress quality and compliance across the manufacturing and support areas

Requirements:

  1. Knowledge of regulatory requirements and guidelines for China and US (preferable)
  2. Strong written and oral communication skillso Strong work ethic and ability to meet challenging timelines, in spite of obstacles
  3. Strong prioritiesand delegation skills with the ability to lead teams to achieve common goals
  4. Must be capable of defining, implementing, and successfully defending sound QA systems’ approaches and principles
  5. The individual must be flexible to effectively embrace change
  6. Demonstrate genuine respect for others. Seeks greater understanding of self and others: seeks feedback about one’s own behavior