？ Ensure that the quality function is adequately staffed, training programs are in-place and the performance review/career development program is properly implemented; Develop and manage the annual budgets for the Biologics Quality function.
？ Ensure that appropriate quality systems and procedures are in-place to ensure product safety/efficacy and compliance with applicable regulations.
？ Working with other functions, define, implement, and supervise the programs aimed at assessing internal and external customer requirements and satisfaction.
？ Ensure that all operations are in compliance with regulatory requirements; in conjunction with the Corporate Quality, handle the relationships with the FDA and other regulatory agencies for inspections and their follow-ups; Ensure that manufacturing and quality procedures correspond to the contents of registration files and regulatory submissions.
？ Provide technical leadership and assistance in quality matters to supply manufacturing intermediates and products.
？ Lead the Biologics Quality organizations in implementing continuous improvement activities; Drive and cultivate a culture of Quality throughout Luye Biologics Operations.
？ Has direct responsibility for Quality Assurance functions including product releases, inspection activities, Events/Deviations/CAPAs Management, Change Control, and documentation control.
？ Has direct responsibility for Quality Control functions including Chemistry, Biochemistry, and Microbiology Laboratories; Direct oversight for analytical method validation and method transfer activities.
？ Has direct responsibility for Validation functions to ensuring a risk-based/science-based lifecycle approach to validation practices regarding facility, equipment and processes.
？ Has direct responsibility for Quality Compliance functions for developing, implementing and leading GxP compliance strategies in alignment with global regulations, including managing GxP training, overseeing the internal and external audit programs, hosting regulatory agency and partner audits, driving response to audit observations, and leading Inspection Readiness efforts across operations.
？ Signature delegation of the Qualified Person (QP) for product release activities.

？ Has a requirement of a minimum of 10-12 years of management experience in quality and/or manufacturing of biologics, medical devices and/or pharmaceuticals.
？ Strong interpersonal skills and ability to work effectively and efficiently in a team environment, ability to work multifunctional, global teams within the organization.
？ Strong leadership and technical skills required, patient-centric mindset
？ Thorough understanding of quality assurance and quality management.
？ Thorough understanding of quality control including analytical method development, method validation and method transfer.
？ Strong cGMP knowledge for biologics and parenteral products.
？ Thorough knowledge of ICH, FDA and EMA requirements and assessment of quality systems.
？ Excellent verbal and written communication skills.
？ Prior experience in managing and developing staff and budget accountability.

上班地址：烟台