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Job Description

Job Title: Supplier Quality Manager CMO/API

Location: US – Remote

About the role:

• Primary responsibilities in performing audit of API and DP product manufacturer, QTA, audit escalation where it is an unsatisfactory audit, involvement in improvement initiatives
• Drive the global Supplier Quality and Material Management programs
• Execution of qualification, maintenance and monitoring for the supplier base in your region, with an emphasis on continuous improvement, global alignment, risk management and supply chain reliability
• Partner with the business and key stakeholders to drive continuous improvement in Quality performance across the company, to understand priorities, align on expectations
• Support global cross functional stakeholders on matters of supplier controls, concerns related to Quality System performance, risk-based audit execution, issue escalation, procurement strategy and regulatory compliance

How you will contribute:

• Execute global supplier and material/product management and audit activities within assigned category and geographical regions including:
  • Communicate with global suppliers
  • Supplier Qualification and Maintenance Audit
  • Quality Agreements
• Support an environment of teamwork and collaboration
• Execute strategic direction and oversight on external auditing and supplier quality and material management
• Achieve sustained success for regulatory inspections and supply chain product quality
• Support the coordination with Site QA auditors, Supplier Quality management groups and global audit planning / scheduling group to assign lead auditors and co-auditors within region to perform audits according to annual (fiscal year) audit plan
• Promptly escalate and all important audit findings, important material issues and supplier performance incidents to the appropriate persons
• Perform external audits (approx. 50 % travel due to audits).

Technical/Functional (Line) Expertise

• Preferably knowledge and experience of Bio-Pharmaceutical, R&D and Vaccines Manufacturing

Leadership

• Prioritizes and manages time effectively to reliably meet timelines
• Open for changes
• Team player

Decision-making and Autonomy

• A member of the Quality Auditing and Supplier Quality team
• Ad-hoc participation with Quality Auditing and Supplier Quality LST

Interaction

• Quality Auditing and Supplier Quality organization
• Partner with Procurement on Supplier Quality Management processes and individual supplier
• Partner with global Manufacturing Sciences Quality
• Partner with Operating units to support business priorities from a supplier quality perspective
• Interact on a routine basis with external partners and suppliers

Innovation

• A firm grasp of industry, scientific and regulatory trends, understands market conditions, and leverages innovation to evolve Takeda’s regulatory profile to become the model for the industry

Complexity

• The complexity in the role lies in the diversity of manufacturing techniques and facilities as the role covers all geographies and therapeutic areas

What you bring to Takeda:

• Preferred Scientific degree (BSc, MSc)
• 5+ years of increasing management responsibility combined with knowledge of pharmaceutical manufacturing
• Experience in Quality Management Systems
• Fluent in written and spoken English, to support communication with Takeda internal stakeholder (local/ global team) and external supplier

Core Competencies / Skills

• Critical thinking, analytical, and problem solving skills
• Communication skills engaging stakeholders: site, supplier
• Courage of conviction and conflict resolution skills.
• Continuous improvement
• Personal accountability for results and integrity
• Strong PC skills and be competent in Word, Excel, PowerPoint and SharePoint

Leadership Behaviors

• Demonstrate effectiveness in task completion, decision-making, empowerment of others, exception management, training, problem-solving and team leadership
• Strategic enterprise thinking, finding innovative ways to serve patients build reputation and trust
• Create the environment that inspires and enable people incl. empowerment of others
• Focus on the few priorities and provide results
• Elevate capabilities for now and the future
• Team player and the ability to lead teams of individuals

What Takeda can offer you:

• Comprehensive Healthcare: Medical, Dental, and Vision
• Financial Planning & Stability: 401(k) with company match and Annual Retirement Contribution Plan
• Health & Wellness programs including onsite flu shots and health screenings
• Generous time off for vacation and the option to purchase additional vacation days
• Community Outreach Programs and company match of charitable contributions
• Family Planning Support
• Professional training and development opportunities
• Tuition reimbursement

Important Considerations:

At Takeda, our patients rely on us to deliver quality products. As a result, we must follow strict rules in our manufacturing facilities to ensure we are not endangering the quality of the product. In this role, you may:

• Work in a controlled environment requiring special gowning and wear protective clothing over the head, face, hands, feet and body. This may include additional hearing protection for loud areas.
• Need to remove all make-up, jewelry, contact lenses, nail polish and/or artificial fingernails while in the manufacturing environment.
• Work in a cold, wet environment.
• Work multiple shifts, including weekends, or be asked to work supplemental hours, as necessary.
• Work around chemicals such as alcohol, acids, buffers and Celite that may require respiratory protection.

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.

This posting excludes Colorado applicants.

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EEO Statement

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, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.

Locations

Massachusetts – Virtual

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

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