Supplier Audit Program Lead


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Job Description

Job Title:  Supplier Audit Program Lead

Location:  Boston, MA

About the role:

  • Responsible for developing and implementing the global strategy for supplier auditing governance.
  • Responsible for the global oversight of supplier auditing program, working with the category leads to ensure timely execution of supplier management activities in line with business needs
  • Driving the execution of the global Supplier Quality Audit risk based programs
  • Development and approval of the annual Quality Auditing and Supplier Quality supplier audit program
  • Collaborating with global cross functional stakeholders on matters pertaining to supplier controls, significant concerns related to Quality System performance, risk-based audit execution, issue escalation, procurement strategy and regulatory compliance
  • Supporting the Access to medicines program Managing the audit planning with timely execution of audits where necessary
  • Responsible for the electronic system for management of the approved supplier list, audit plans/schedule and completion of the audit program goals in full and on time

How you will contribute:

  • Execution of global supplier and audit activities globally and in conjunction with category leads and business partners:
    • Building relationships with global / critical / strategic suppliers
    • Solving of material related issues in cooperation with impacted facilities and suppliers around the globe (Audit findings, Material Deviations, CAPAs)
    • Collaborate with business operational units in Supplier Qualification and maintenance / Quality Agreements
  • Support the maintenance of an environment of teamwork and collaboration
  • Execute the strategic direction and oversight pertaining to external auditing and supplier quality and material management achieves sustained success for regulatory inspections and supply chain product quality
  • Execution of global supplier and audit activities globally and in conjunction with category leads and business partners:
    • Building relationships with global / critical / strategic suppliers
    • Solving of material related issues in cooperation with impacted facilities and suppliers around the globe (Audit findings, Material Deviations, CAPAs)
    • Collaborate with business operational units in Supplier Qualification and maintenance / Quality Agreements
  • Support the maintenance of an environment of teamwork and collaboration
  • Execute the strategic direction and oversight pertaining to external auditing and supplier quality and material management achieves sustained success for regulatory inspections and supply chain product quality
  • Support the preparation and the maintenance of GSQM policies, guidance, standards, procedures governing Quality Auditing and Supplier Quality and ensures staff comply with the documents
  • Support the coordination with Site Quality 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 report all critical audit findings, critical material issues and supplier performance incidents to the appropriate persons
  • Perform internal/external audits as needed
  • Support Due Diligence activities worldwide providing subject matter expertise to enable decision making; identifying quality related risks to projects and the provision of appropriate resolutions
  • Executes the Supplier Qualification and supplier audit program requirements per schedule
  • Provides performance metrics to drive continuous improvement of the programs
  • May require up to 50% travel
  • Other duties as assigned

What you bring to Takeda:

  • Scientific degree (BSc, MSc)
  • 10+ years of increasing management responsibility combined with deep knowledge of biopharmaceutical manufacturing
  • Experience about Quality pillars (QA, QC, Systems and Compliance, Services and Improvement) including global cGMP regulations (US, EU, Japan, Canada, etc.)
  • Experience working with regulatory agencies and/or direct interface experience with regulatory agencies during inspections highly desirable/preferred.
  • Effective finance and controlling knowledge and competencies to manage functional budget
  • Fluent in written and spoken English

Core Competencies / Skills

  • Critical thinking, analytical, and problem-solving skills
  • Understanding of local and global regulations
  • Communication skills engaging stakeholders: site, business, network, company, regulators.
  • Courage of conviction and conflict resolution skills.
  • Risk identification, evaluation and management
  • Continuous improvement
  • Personal accountability for results and integrity
  • Ability to present key quality/department/business concepts to senior representatives of external business partners and internal senior leadership teams.
  • Strong PC skills and be competent in Word, Excel, PowerPoint and SharePoint

Leadership Behaviors

  • Demonstrates effectiveness in task completion, decision-making, training and problem-solving
  • Focusing on the few priorities and provide superior results
  • Elevating capabilities for now and the future
  • Team player
  • Ability to drive change

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.

#GMSGQ

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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

Boston, MA

AUT - Vienna - Kärntner Ring

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time


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