Area Head Commercial Quality MCO EE

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Job Description

About the role:

As a primary member of the Region EUCAN Commercial Quality Leadership Team, you will provide guidance to LOC/Commercial Quality across MCO Eastern European countries to establish, maintain and improve the local Quality Management strategy in alignment with Takeda's 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. You will ensure strong cross-functional collaboration focusing on patient's needs, regulatory compliance, and continuous improvement, and serve as the Global Quality contact with important Commercial Leaders and partners in the MCO EE on quality matters and initiatives impacting the LOCs.

This is a hybrid role that reports to the Regional Head Commercial Quality, EUCAN Region.

How you will contribute:

• Provide leadership, guidance and technical expertise to LOCs in the group on quality matters, managing the performance and development of the team and creating an environment that allows people to succeed and move the organisation forward through our Quality Culture.
• International travel up to approximately 25%
• Ensure delivery of business strategy, Key Performance Indicators (KPIs) and GQ goals following quality and regulatory compliance.
• Guide timely resolution of product quality & compliance issues in or affecting LOCs in the group and support escalation/communications across the network.
• Manage programs to bring sustainability and compliance to Takeda QMS and local regulatory requirement in LOCs.
• Implement quality improvement programs, quality risk management programs and compliance education initiatives, and spearhead digital quality initiatives in the group.
• Lead regulatory surveillance and intelligence in the group for new regulations.
• Provide guidance and support inspection readiness of group LOCs to maintain a favorable 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) and activities affecting the PV system, e.g PV, Regulatory Affairs activities.
• Identify areas of opportunities in the group for quality capability-building and lead programs to strengthen quality decision making.
• Promote a culture of continuous improvement and implementation of best practices across the cluster.
• Be the Quality Business Partner with Commercial Leaders and important partners in group LOCs and work in collaboration with Quality R&D, Pharmacovigilance, Regulatory Affairs and Medical to guarantee a comprehensive approach to business quality processes.

What you bring to Takeda:

• Scientific degree (BSc, MSc)
• 10+ years of increasing management responsibility in the pharmaceutical industry including Quality Assurance, 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.
• Fluent in written and spoken English.

More about us:

At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.

Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

Empowering our people to shine:

Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, or any other characteristic protected by law.

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