- This role of China Product Quality Lead (CPQL) is to strengthen the global/local interfaces to enable successful product submission, launches and pipeline products, drive timely resolution for quality issues affecting China, including product life cycle for both commercial products and products at late-stage development.
- The CPQL is responsible for the quality oversight of China BU product portfolio.
- The CPQL is the quality liaison between China GRA Strategy, GRA CMC, Launch Excellence, and global/OpU Product Quality Leaders (PQLs), to ensure compliance of GMP/GDP operations in support of assigned programs for China products.
- Support global network to align understanding of, and consistent interpretation of China regulatory, ChP and product quality requirements.
- Collaborate with global/OpU quality teams by providing China quality expertise in accordance with China regulatory requirements and internal policies.
- Support quality review of regulatory submissions (i.e., filings, annual reports, responses to questions), ensuring submissions are in line with China GMP requirements and are verified for accuracy and data integrity.
- Support the Incident Escalation process.
- Maintain oversight of CBU product performance and develop sustainable compliant product with continuity of supply.
- Provide quality oversight and guidance during China product launch and post-market variations in collaboration with CBU and GMSGQ stakeholders.
- For development products, in collaboration with global stakeholders, develop product knowledge repositories and utilise product expertise to support China product lifecycle.
- Collaborate with PQLs and other leaders across the organization and assist in the continuous improvement and product lifecycle management in compliance with GMP/GDP requirements..
- Support PQLs in APQR review and approval (where applicable).
- Support health authority inspections and partner audits (where applicable).
- Perform duties as assigned to ensure compliance to global and local regulations.
- Min. 8 years of experience in Quality area with increasingly responsible job requirements.
- At least 4 years of Product Quality Assurance experience in a GMP environment.
- Bachelor's degree or above in a scientific discipline
- Self-directed and highly motivated team player with solid organizational capabilities
- Experience in global pharmaceutical operations, supply chain management, Quality, project management and global environment
- Thorough understanding of regulatory/compliance requirements for China
- Show strong negotiation skills and customer focus
- Demonstrate ability to prioritize work, manage multiple projects, act and work independently
- Knowledge and understanding of global and local quality and regulatory concepts and requirements (e.g. Chinese Pharmacopoeia (ChP), ICH, FDA GMP, EU GMP, PIC/S GMP, Compendia).
- Full understanding of relevant cGMP, ICH and other global regulatory CMC guidance documents applicable to the manufacturing and testing of launch and commercial products.
- Ability to act locally as well as engaging with Global teams to support global activities.
- Ability to interact and work with a variety of local and global stakeholders.
- With exceptional communication and stakeholder management, serve as owner and/or leader to manage assigned projects.
- Ability to use own initiative and make the difficult decisions.
- Cross-cultural awareness and sensitivity
- Excellent written and verbal communication skills, with and ability to manage stressful and confrontational situations to positive outcomes
- Strong communication skills in engaging local and global stakeholders (quality, manufacturing, supply chain, business, network)
- Strong relationship building skills, and ability to work in partnership cross functionally with global stakeholders
- Strategic enterprise thinking with innovation mindset
- Ability to operate in an internal and external business environment globally, across different cultural considerations and complex regulatory frameworks.
- Effectively articulate complex technical product quality issues concisely and deliver effective presentation on complex technical subjects to non-technical audience.
- Bachelor degree or higher, with major in scientific, engineering, medical or equivalent discipline.
- Digital and analytical skills
- Critical thinking and problem solving
- Strong communication skills in engaging local and global stakeholders (quality, manufacturing, supply chain, business, network)
- Strong relationship building skills, and ability to work in partnership cross functionally with global stakeholders
- Strategic enterprise thinking with innovation mindset.
- Fluent in Chinese and English, both written and spoken
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Product Quality Lead, Quality, Shanghai - Takeda
描述
Description
This role is accountable for the following responsibilities:
Qualifications and Skills:
Technical/Functional (Line) Expertise
Leadership
Decision-making and Autonomy
Interaction
Innovation
Complexity
Locations
Shanghai, ChinaWorker Type
EmployeeWorker Sub-Type
RegularTime Type
Full time
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