Head Commercial Quality—China, Quality, Shanghai

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OBJECTIVES/PURPOSE

• As a core member of the Commercial Quality Leadership Team, the Quality Head, China provides leadership and strategic direction to the Country Quality teams to establish, maintain, and improve the local Quality Management strategy in alignment with Takedas Global Quality Breakthrough Objectives and Strategic Imperatives.
• Responsibilities cover GxP-regulated activities including in-country distribution quality, local Health Authority relationships, local quality surveillance, local contract manufacturing/packaging/analytical testing quality oversight, and in-country clinical and medical device activities.
• As a member of the China Business Unit Leadership team (CBU LT), the incumbent is responsible for establishing and maintaining strong relationships with key stakeholders in the Business Unit, and with other Global functions (e.g. GMS, Regulatory, and Medical Affairs). The Quality Head, China will ensure strong cross-functional collaboration focusing on patients needs, regulatory compliance, and continuous improvement as a driver for innovative change and business transformation for Quality.
• Serves as the Global Quality point of contact with key Commercial Leaders & stakeholders in the China region on quality matters and initiatives impacting the LOCs.

How you will contribute:

• Responsible for Quality teams in Beijing, Shanghai, Taizhou Distribution Centre and Hongkong/Macau.
• Provide leadership, guidance, and technical expertise to CBU on quality matters, managing the performance and development of the team and creating an environment that allows people to thrive and move the organization forward through our Quality Culture.
• Ensure successful delivery of business strategy, Key Performance Indicators (KPIs) and GQ objectives in adherence to quality & regulatory compliance.
• Drive timely resolution of product quality & compliance issues in or affecting LOCs in the China region and support escalation/communications across the network.
• Spearhead and manage initiatives to drive sustainability and compliance to Takeda QMS and local regulatory requirements in the regional LOCs.
• Implement quality improvement programs, risk management programs and continuing quality compliance education for area of responsibility.
• Lead regulatory surveillance & intelligence in region for new or emerging regulations, and engage externally to strengthen professional relationships with industry associations, and regulatory bodies.
• Provide guidance and support inspection readiness of regional LOCs to maintain a favourable regulatory profile with Heath Authorities.
• Implement Supplier Quality Program in the LOCs using a lifecycle management approach for local GxP suppliers (includes selection and qualification, Quality Agreements, and oversight).
• Ensure there is quality oversight of local GCP/GVP/Devices/Medical related activities, such as for local studies (e.g., Investigator Initiated Trials (IITs), Collaborative studies, Interventional studies (NI), Non-Interventional Studies (NIS) & activities impacting the PV system, e.g PV, Regulatory Affairs activities.
• Champion a culture of continuous improvement and innovation, and the implementation of best practices across region.
• Elevate LOC quality capabilities in the region to strengthen quality decision-making and drive the advancement of Takedas Quality vision and roadmap.
• Serve as the Quality Business Partner with Commercial Leaders & key stakeholders in the region and work in collaboration with the areas of Quality R&D, Pharmacovigilance, Regulatory Affairs and Medical to guarantee a comprehensive approach to business quality processes.

Technical/Functional (Line) Expertise

• Strong knowledge of the regulations in China
• Deep understanding of LOC/Commercial Quality requirements, including regional and in-country distribution, controlled substance compliance, supply chain quality, and local quality surveillance (returns, recalls, complaints), and contract manufacturing/ testing quality oversight.

Leadership

• Ability to lead effectively a regional Commercial Quality team.
• Ability to identify and develop diverse talents and elevate capabilities and performance of the team.
• Ability to collaborate and partner well at a leadership level, regionally & cross-functionally with numerous stakeholder groups.
• Ability to lead effectively through directing change, as well as driving change by influence.
• Ability to make difficult, but robust and rationalised Quality decisions enabling Takeda to deliver on its commitment to put patients first and build trust with society.
• Ability to build a customer & patient-centred best in class organization, develop diverse talent and elevate organizational performance, by partnering with stakeholders.
• Delegate for Global Head Commercial Quality.

Decision-making and Autonomy

• Responsible for resource management and workload allocation within the Regional Commercial Quality team including budget responsibility for the region.
• Responsible for driving timely execution of market actions and Health Authority communications in the region once the decision had been aligned.

Interaction

• Key interactions with China Quality colleagues in region to drive performance & maintain compliance.
• Key interactions with regional business, commercial leaders/GMs/Medical Heads and GMS/GSC and other key stakeholder groups including Regulatory Affairs to stay abreast with business and network strategy and respond promptly to evolving business and QA resourcing needs.
• Key interactions across manufacturing and Quality regional and operating unit teams & other quality functions to enable timely issue resolution.

Innovation

• A strong understanding of industry, scientific and regulatory trends in China, and its market conditions and requirements.

Complexity

• Multiple countries, supply & distribution models, regulatory frameworks, clinical study and medical device requirements, and a wide diversity of products.

What you bring to Takeda:

• Scientific degree (BSc, MSc).

• Clearly demonstrated increasing leadership responsibility, combined with a strong knowledge of regulations pertaining to pharmaceutical manufacturing and distribution in the region.
• In-depth knowledge of global pharmaceutical operations, supply chain / distribution management, CMO management, Quality.
• Strong interpersonal skills including conflict management, ability to lead teams in a regional or global environment, and adept at interacting across different levels. Experience includes successful examples of managing and leading by influence.
• Fluent in written and spoken Chinese and English.

Qualifications & Skills:

• Critical Thinking
• Investigation and problem solving
• Strong communication and stakeholder management skills
• Ability to influence and work effectively across the region and with different cultures
• Risk identification, evaluation, and management
• Continuous improvement
• High level of agility and able to manage complexity & balance priorities
• Strong executive presence

Leadership Behaviours

• Strategic enterprise thinking, finding innovative ways to serve patients build reputation and trust.
• Creating the environment that inspires and enables people.
• Focusing on the few priorities and provide superior results.
• Elevating capabilities for now and the future.

ADDITIONAL INFORMATION

International travel as required up to approximately 25%

Information :

• Company : Takeda Pharmaceutical
• Position : Head Commercial Quality—China, Quality, Shanghai
• Location : 上海市
• Country : CN

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