HireDiversity

Guangzhou (Canton), CN

Sr. Project Manager-Guangzhou Bioseal Plant-000008DF

Description

The employee of this position will sign labor contract with Guangzhou Bioseal Biotech Co., Ltd

• Manage multiple key projects for the organizations.
• Solid pharmaceutical, Biopharmaceutical and or Chemical operational experience
• Strong engineering and/or scientific knowledge of general processes in the pharm industry
• Manage major capital production expansion project(s) that includes R&D , Quality Laboratories and distribution expansions
• Interface and manage external consultant firms and governmental agencies
• Strong interpersonal and influence skills
• Prioritize activities to align with the overall company objectives.
• Good working knowledge of SAP or other production control (IT) systems to support operations, quality (CAPA, Change Control, Documentation Control), maintenance and engineering and/or planning and logistics
• Deep expertise with process and equipment validation requirements. Lead Root Cause Analysis and technical trouble shooting. Knowledge of Process Excellence.
• Working knowledge of Quality Compliance CAPA, Deviations & NCR Systems, Statistical Techniques. Quality and production Metrics and analysis.
• Handle complex projects and assures delivery of the improvements in a cross-functional, timely and cost-efficient manner.
• Proactively identifies, evaluates and implements process changes and improvements. Ensures proposed process changes are consistent with applicable regulatory requirements and assures changes that affect a regulatory submission or require communication to regulatory authorities are appropriately conveyed.
• Oversight to technical documentation required to upgrade existing process and internal controls.

Qualifications


• Bachelor's degree in Engineering or related technical fields, Master's degree is a plus.
• Major project management experience.
• Minimum of 7 years experience in plant level pharmaceutical or biologics operations.
• Knowledgeable of sFDA/EMEA/TGA regulatory requirements applicable to biologics or pharmaceuticals. Ability to apply China GMP regulations and other FDA and international guidelines to all aspects of the position.
• Excellent communication skills, English fluent a minimum, Mandarin fluency strongly preferred.
• Must have strong leadership experience with a track record of developing and mentoring teams.
• Experience with combination products is desirable.
• Demonstrated project management skills with strong ability to negotiate and influence in a highly matrixed environment.
• Strong organizational skills; ability to prioritize and manage through complex processes/projects.

Primary Location:Asia Pacific-China-Guangdong-Guangzhou (Canton)
Organization: Johnson & Johnson Medical Shanghai Ltd. (7055)
Job Function: Plant Management