上海市-浦东新区 | 1人
The STA Quality organization is responsible to ensure the STA manufacturing sites are operating in compliance with the applicable laws, standards, best-practices, and Customer’s requirement by deploying, maintaining, and improving the GMP Quality Systems and the overall Quality culture.
The position holder is responsible to ensure the proper oversight and support of the STA Quality Management System, the continuous improvement of the GMP processes and the pro-active implementation of quality requirements across the STA sites.
As a member of the Quality Leadership Team, the position holder is collaborating with the other members of the QLT and stakeholders to ensure that the Quality Systems are maintained, implemented and improved at all STA sites.
Responsibilities：
• Builds and leads the STA Quality System organization ensuring that adequate staff, organization and processes are available to complete the assigned role
• Directs and manages the STA Quality system, by managing STA Quality IT systems (e.g. Veeva, Trackwise, …) and STA Quality policies, standards and procedures.
• Provide quality and compliance guidance to the STA staff and sites. Drive quality improvement projects and continuous improvement, based on metrics, audit learning, trending and other inputs.
• Manages the STA Compliance auditing program, to confirm consistent application of STA Quality standards across the sites
• Manages Regulatory intelligence and pro-active implementation of new and emerging regulations.
• Manages role out of STA Quality System to new STA sites and actively supports STA business growth from a Quality perspective
• Actively involved with defining quality standards for new technologies (e.g. continuous manufacturing, sterile technology, flow, new modality)
• Optimize and actively drive STA Quality Culture program
• Participate in the preparation and execution of regulatory inspections at STA sites
• Drive communication and cooperation with the internal and external customers and ensure customer satisfaction.
• Ensure that your group members receive proper coaching, training and follow up to comply with company and department policies, including EHS and IP protection policy.
PhD/Master in pharmaceutical, chemical or analytical sciences or equivalent degree. Be proficient in pharmaceutical manufacturing processes, support and GMP regulations.
• More than 10 years’ experience in Quality Assurance or other relevant functions in regulated environment; more than 6 years people leadership and team management experience.
• Excellent in presentation and communication in English
• Demonstrate ability in problem solving, communications, quality system implementation and team building.
• Demonstrated ability of pro-active thinking and setting up systems for prevention of quality issues
• Demonstrate outstanding and balanced quality leadership.
• A talent for fostering resources optimization, continuous improvement and operational efficiency.
• Exceptional skill for analyzing problems and finding innovative solutions.
• Proven ability to motivate, mentor and work efficiently, as well as with persons from other cultures, as in cross-functional and self-directed work teams