Key Responsibilities:
?Lead and manage the Quality Assurance organization of Shanghai Henlius (located in Shanghai, China), to achieve the strategic goals of the company.
?Responsible for leading and managing Henlius Biopharma’s quality assurance initiatives and quality assurance plans that are executed and maintained in full compliance with CGMP requirements. This includes addressing issues from quality operation oversight and helping the quality management team to execute effectively the quality enhancement activities.
?Direct and support the resolution of quality problems in the manufacturing operational activities so that they are consistent with the industry and company quality standards.
?Support and supervise quality governance through review of project documents, KPIs, risk assessments, and quality plans.
?Identify and support continuous improvement projects in collaboration with different functional group management to achieve quality, reliability and cost improvement objectives.
?Lead the preparation and execution of internal, external and regulatory audits on the site.
?Participate in or manage quality assessments related to introduction of new products into the facility.
?Ensure that coordinated contact is maintained with other functions, including sharing of better practice and procedures.
?Escalate all critical and major quality issues to company executive leadership team to ensure timely resolutions of the issues.
?Perform review of compliance performance at department and individual level and propose corrective actions.
?Provide coaching and direction for QA team leaders, and provide training to relevant staff, as requested.
?Anticipate risks associated with product quality and regulatory compliance, through the prevention and reduction plans, including management of quality and product alerts.
?Provide quality support and expertise in the GMP projects such as non-conformance remediation plan, tech transfers, GMP facility projects, and the launch of new products.
?Contribute significantly to the development of best practice within the scope of GMP compliance and regulatory requirements; facilitate interaction and exchange of best practices with other departments and functional areas.
?Develop GMP and QA knowledge and implementation to its highest standard, which is essential for the company to maintain its strong quality culture.

Qualifications:
?Advanced degree (Master or PhD) within pharmacy, biology or engineering and with at least 10 years’ managerial experience in a production and/or quality function in the biotechnology / pharmaceutical industry.
?Must be bilingual in English and Chinese.

Experience and Knowledge:
?Expert in quality system implementation & improvement, which include but are not limited to Product Release & Production Batch Record, SOP, Training, External & Internal Audit, Regulatory Inspection, Change Control, Data Integrity, Customer Complaint Management, Deviation and OOS Investigation, Quality Risk Management, External Supplier/Vendor Quality System, Quality Agreement, Quality Metrics, and CAPA Management for Non-conformance.
?Demonstrated leadership & experience in staff skill development, performance appraisal and department budget management.

Key Competencies Required:
?Results orientated.
?Demonstrated ability to achieve results and manage others to achieve functional and company objectives.
?Ability to integrate the constraints of each function and identify good solutions while within compliance of regulation.
?Team performance complemented by development of skills and performance of individual team members.
?Strong leadership.
?Strategy development and execution.
?Combined strategic and operational thinking.
?Focus on goals with sound judgment.
?Ability to manage multiple priorities and act with a sense of urgency.
?Pro-active and creative by designing new processes and implementation of those to promote process improvement continuously.
?Ability to work in a matrix, multicultural environment.
?Driven by building interpersonal and a proven team builder.

上班地址：上海市徐汇区宜山路1289号