Manager, External QA

EXTERNAL QUALITY ASSURANCE -Senior Specialist Qualified Person (QP) China The Position The Product Quality Manager (PQM) is responsible for ensuring that all Company products managed by External Quality Assurance (EQA) are manufactured, packaged, analyzed, released, stored, and distributed in accordance with Company expectations and all applicable regulatory requirements. Role has primary batch release responsibility and ensures that effective and robust Quality systems are in place to comply with required regulations, policies and guidelines governing the EP/ExP’s manufacture and release of ( non-sterile pharmaceuticals, sterile pharmaceuticals, medical devices ) by means of risk-based quality oversight and on-site supervision, as appropriate. PQM will support partner relationships with activities of increasing complexity, scope, and volume which can be influenced by one or more of the following: number of products manufactured, number of partners supported, production volumes, number and complexity of in-markets, historical performance (production and compliance), new product or market launches, historical relationship between our company and the partner, manufacturing process complexity.

Evaluate and/or release products to other sites and/or to the market with the assurance that the goods were produced in conformance to all applicable policies/procedures of our company and compliance with all governing regulations; review and approve changes to master batch records Manage routine and complex deviations and complaints, and assist in the coordination of significant investigations including Fact Findings; assist in the coordination of any product recall involving the external manufacturer Conduct audits of EP/ExP by the Company and regulatory agencies; review audit outcomes pertaining to external manufacturers and ensure appropriate and timely corrective actions are warranted Oversee repackaging activities in the ExP/EP Conduct routine and solves complex analytical change requests and support process modification change controls Stability Program management, including review of stability reports, and Annual Product Review assembly Provide on-site guidance in the preparation of metrics, procedures, and guidelines; provide proactive support in training and coaching to initiate quality improvements Track and monitor operational and quality performance of the external manufacturer/partner and can work with supplier to develop CAPA plans Assist the maintenance of retention samples, ship reagents and samples to support licensure and foreign registration; responsible for shipment under quarantine Support routine process validation; review and approve validation reports/tech transfer Prepare pre-PAI assessments; support document requests for regulatory filings and post approval changes Regular site visits to build relationships and monitor efforts to improve the external manufacturer’s quality and reliability through ongoing oversight and formal communication programs and forums Required Education, Experience and Skills: Degree in Pharmacy, Chemistry, or Chemical Engineering or equivalent Minimum 5 years previous experience in multinational pharmaceutical industry in laboratory testing and in-process quality control.  Thorough knowledge of Quality Systems, Quality Assurance, and Quality Control including global GMP Quality Systems and regulatory requirements preferred. Solves complex problems; takes a new perspective using existing solutions Works independently, receives minimal guidance Acts as a resource for colleagues with less experience within own discipline; can provide minimal guidance on issue resolution and act as SME May act as a team or project lead and lead work of others as required; promotes teamwork and open discussion of issues, coaches and guides others Explains difficult issues and works to build alignment around a complex situation Accountable for a medium project with minimal