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Job Description

About the role:

• Leads; manages and improves elements of the Quality Systems at Takeda External Biologics
• Responsible for leading and developing quality systems in line with the Global Takeda and External Biologics requirements
• Act as the link between Global Systems and External Biologics site as Systems Execution Lead
• Provide SME support during audits and inspections on Quality Systems

Optional hybrid work model.

How you will contribute:

• Responsible for managing, monitoring and improving the Biologics External Supply team Quality Systems
• Responsible for leading quality systems, providing knowledge to SME and supporting the compliance and closure of these systems: e.g. Deviations, Change Controls, CAPAs, PQR, MRB, Training, metrics, and other systems as needed
• Lead and maintain the Product Quality Reviews process for External Biologic Products
• Responsible for leading Quality Council for External Biologics Supply
• Responsible for leading metrics with the Quality External Biologics team to drive the performance
• Responsible for supporting integration activities and leading through quality system changes
• Develop and maintain visibility for quality systems (for example, Change Controls and Deviations) and lead the team to ensure accountability and the timely closure of these records.
• Maintains knowledge of current applicable global regulatory requirements.
• Applies knowledge of cGMPs on a daily basis.
• Manages day-to-day operations independently.
• Presents viable alternatives within problem resolution and assists to ensure risk mitigation.
• Routinely partners with senior management on critical issues.
• Participate and lead Continuous Improvement Projects

Technical/Functional (Line) Expertise

• Strong knowledge of cGMP/GLP regulations, ICH, FDA CMC Guidance Documents and other Regulations.
• Strong technical, interpersonal, communication and leadership skills.
• Knowledge of techniques utilized in pharmaceutical sciences.
• Strong organizational and thinking skills.
• Demonstrated knowledge in biologic and aseptic manufacturing, systems and process technologies with strong regulatory and cGMP background for drug substance and drug product manufacturing.
• Management/leadership in operations and/or manufacturing in biopharmaceutical/pharma industry

Leadership

• Energy & Drive – committed to Takeda values of Patient, Trust, Reputation and Business
• Be Positive and embrace change – help others understand rationale and positive impact of change
• Be Accountable
• Be An Excellent Manager of Self and Others

Decision-making and Autonomy

• Demonstrated judgement ability to know when it is appropriate to take decisive action and move efficiently
• Demonstrated strength in cross boundary communication, influencing others, building cross-functional teams for inspection readiness and execution

Interaction

Internal:

• Consult and collaborate across all external supply and pertinent Global Manufacturing and Global Quality Functions
• Consult and collaborate with System Business Process Owners

External:

• Interacts closely and builds strong relationships with external organizations including:
  • Contract manufacturing drug substance, drug product and packaging sites

Innovation

• Enlists sound judgment and implements analytical, creative approaches to solve complex problems. Demonstrates innovative problem solving and analytical skills.

Complexity

This role requires a significant wide-spectrum understanding of pharmaceutical manufacturing and the associated requirements. The incumbent will be required to work cross functionally and engage with internal and external stakeholders.

What you bring to Takeda:

• Requires a degree in a scientific/technical discipline with minimum 8 years experience in Quality Systems/Compliance in Biologics/sterile manufacture and industry managerial experience within manufacturing/Quality.
• 8 or more years experience leading and managing highly effective technical, manufacturing or Quality teams and developing people and in particular Q Systems or compliance teams
• Recognize the importance of meeting patient, compliance and business needs
• Experience in a multinational organization effectively navigating differing regional expectations and regulations

What Takeda can offer you:

Full Healthcare Cover - includes dependents

Pension Scheme

Attractive Bonus

Subsidised canteen

Parking facilities with electric car charging points

Health & Wellness programs including onsite flu shots and health screenings

Educational Assistance

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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