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Internal & Supplier Audit Lead

応募 後で応募 求人ID R0010155 掲載日 07/12/2019 Location:Cambridge, Massachusetts

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Job Description

Are you looking for a patient-focused company that will inspire you and support your career? If so, be empowered to take charge of your future at Takeda.  Join us as an Internal & Supplier Audit Lead (Associate Director) in our Cambridge office.

Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As an Internal & Supplier Audit Lead (Associate Director) working on the R&D Quality team, you will be empowered to coordinate the execution of the overall Internal Suppler Audit strategy and R&D QA & Compliance (QA&C) Operational objectives, and a typical day will include: 

Primary responsibilities of this position are to:
• Provide professional expertise and strong leadership in applicable guidance and regulations, proactively identifying potential areas of non-compliance and risk for assigned areas.
• Execute Internal Supplier Audit strategy at the direction of the Head of Internal & Supplier Audits
• Serve as a QA & Compliance Liaison for Preferred Providers Governance Councils or internal committees, as assigned
• Provide Compliance & Management Support for identified issues arising with supported R&D Business areas, and for other QA & Compliance project initiatives
• Provide support for QA & Compliance Regulatory Agency Inspections


Audit Coordination
- Liaise and network with internal and external business partners to implement ISA strategy
- Lead the planning, execution and close out of assigned ISA audits
- Lead ISA driven CAPAs, effectiveness checks, and issue escalation, as assigned
- Designated auditor/co-auditor for assigned ISA audits
- Lead ISA facilitated meetings.
- Participate in QA&C project initiatives (System Development and COE driven)

QA&C Liaison for Preferred Provider(s)
- Liaise and network with internal and external business partners to provide guidance and support pertaining to compliance/quality oversight initiatives
- Prepare and lead or support governance council meetings
- Facilitate issue escalation and oversight of remediation as appropriate
- Manage preferred provider partnership as assigned

Internal Supplier & Audits and QA & Compliance Support
- Liaise and network with internal and external business partners to implement ISA and QA&C initiatives
- Lead and/or support the planning, execution and close out of assigned ISA and QA&C initiatives
- Provide compliance guidance and support for R&D as appropriate
- Provide support to management as requested

Regulatory Agency Support
- Support, as needed, the preparation, conduct follow-up/responding, and lessons learned to GXP inspections

Education and Experience Requirements
• Bachelor’s degree in a life science or equivalent experience; Graduate degree in a scientific discipline or program management a plus
• Minimum of 8 years’ of pharmaceutical experience, including international experience
• Ideal candidate will have broad experience in product development, regulatory compliance, supplier management, GxP auditing and at least 3 years of direct or matrix management experience.

Key Skills, Abilities, and Competencies
• Extensive knowledge and/or awareness of local and international regulations. Maintains awareness of newly published regulations.
• Strong understanding of the: drug development processes, clinical development operations, vendor outsourcing and procurement processes, regulatory affairs, GXP and internal process auditing
• Collaborative team player who has the ability to think and act quickly and identify creative solutions to complex problems
• Robust technical writing skills. Ability to write briefing documents, quality positions, audit reports and SOPs.
• Strong attention to detail with the ability to articulate quality related risks and potential impact.
• Leadership skills, and ability to inspire colleagues
• Ability to take a big-picture approach to decision-making while taking account of the broad interests of Shire.
• Strong project management and decision-making skills
• A self-starter, who motivates, has tact and diplomacy and is able to define and prioritize tasks within a project
• Excellent communication and interpersonal skills.
• Demonstrates ability to manage global staff/activities
• Ability to foster and balance a culture of compliance within a culture of innovation
• Strategic thinking
• Ability to influence without authority, in a matrix environment
• Proficient knowledge of MS Word, Excel, PowerPoint & Outlook; working knowledge of Access, Trackwise a plus.

Complexity and Problem Solving
• Exerts influence in the development of overall objectives and long-range goals of the organization.
• Acts as an advisor to meet schedules or resolve technical or operational problems
• Directly participates in establishing and administering centralized functional projects
• Works on complex problems requiring analysis of situations or data and in-depth analysis of factors
• Exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results.

Internal and External Contacts
• Interacts across R&D QA & Compliance and R&D Business Partners

Other Job Requirements
• Domestic and international travel may be required per business need.
• Must have a global mindset.


  • 401(k) with company match and Annual Retirement Contribution Plan
  • Tuition reimbursement
  • Company match of charitable contributions
  • 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

Empowering Our People to Shine

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Cambridge, MA

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Time Type

Full time

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