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Director Global Regulatory Affairs, Audits, Inspections and Compliance

Company: Takeda Pharmaceutical
Location: Lawrence
Posted on: November 22, 2022

Job Description:

By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge.

Job Description

About the role: At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide.

Join Takeda as a Director Global Regulatory Affairs, Audits, Inspections and Compliance where you will be responsible for overseeing the support to audits and inspections related to the Global Regulatory Affairs (GRA) activities including: strategy, inspection readiness, inspection support, post inspection activities and continues improvement. Leads the interaction and collaboration with various stakeholders including but not limited to the R&D QA, Global QA,GPSE, GCP, CROs and LOCs partnering with Regional Compliance. Responsible for implementing and executing the internal audits program for the Global Regulatory Affairs organization including activities performed by CRO's and external partners on behalf of Takeda's Global Regulatory Affairs. And, Ensure alignment with global strategic initiatives related to regulatory quality and compliance.

You will also have responsibility for the Global Regulatory Affairs Compliance and Quality processes. Supports the assessment and implementation of the Global Regulatory Affairs actions resulting from new/updated regulations. Act as strategic partner with the Global Regulatory Affairs organization in the development and monitoring of regulatory labelling and CMC compliance processes and systems. Identify potential areas of compliance vulnerabilities and risks related to GRA functions and processes and develop strategic initiatives and/or mitigation plans to reduce risk.

As part of the Global Regulatory Affairs, Audits, Inspections and Compliance team, you will report to the Senior Director, Head of Compliance, Global Regulatory Affairs.

How you will contribute:

  • Responsible for demonstrating Takeda leadership behaviors.
  • Lead the Global Regulatory Affairs activities related to audit and inspections.
  • Lead and support critical Compliance Global Regulatory Affairs projects.
  • Act as the primary contact to Quality and Global Quality organizations for audits, inspections and GxP/regulatory processes.
  • Ensure effective collaboration with and serve as an GRA compliance advisor to other functional partners within Global Quality and the Global Development Office/GDO (PV, Clinical Development Operations, Clinical Supplies Management, and Development Support) representing GRA and support the culture of compliance.
  • Lead the GRA cross functional workstream to support the GRA-Partnerships related actives (TDOM-TTDOM and others applicable).
  • Support the process to assess Regulatory Compliance requirements, new/revised global regulatory GxP requirements and identify the impact to the Takeda's operation.
  • Co-development of relevant GRA metrics to track regulator commitments ( audits and inspections, and Health Authority requests). Communicate issues/trends to GRA leadership.
  • Partner with the Compliance QMS and Regional Compliance organizations to develop and implement the Quality elements into the GRA processes and systems.
  • Collaborate and build relationships with regional/LOC team members for the development and implementation of GRA compliance requirements.
  • Support the labelling and CMC functions on the implementation of the regulatory compliance processes and systems.
  • Support the RA LOCs on the implementation of the Quality and Compliance processes and systems.
  • Support the implementation of the regulatory compliance related elements in the GPSE and GCP processes and systems.
  • Consistently foster and exhibit exemplary leadership behaviors, inclusiveness and ethics.
  • Inspection/Audits: Responsible for GRA, CRO's and GRA external partners and LOC regulatory inspection or internal audit readiness for dedicated GRA/QMS/GxP Inspections/audit;
  • Ensure all inspection and audit issues related to Global RA and findings are addressed adequately; Partner with GDO, LOCs and other global cross-functional partners in local inspection/audit activities as needed; and oversee corrective and preventive action plans (CAPAs). Support regional/Los in addressing issues identified in CAPAs as needed.
  • Identify and lead the implementation of GRA opportunities for automation and process excellence. Minimum Requirements/Qualifications:
    • Bachelor degree in a science or business-related field, MSc or PhD preferred.
    • At least 10 years of experience in the pharmaceutical industry, with 3 years in regulatory Affairs, research and development, quality assurance/compliance.
    • Familiarity with inspection and audit procedure.
    • Ability to identify proactively and anticipate risk of non-compliance in a complex environment.
    • Demonstrated knowledge of global health authorities, regulations, product approval and lifecycle processes for major markets and of pharmaceutical and regulatory affairs requirements and practices.
    • Practical operational experience of working across disciplines and across multiple regions. Experience working within a global ream framework and a multi-cultural environment. Efficiently/actively manages conflict in a tactful, diplomatic way, seeking effective solutions for all parties.
    • Able to manage both time and priority constraints and to manage multiple priorities simultaneously.
    • Capability to critically analyze complex and/or ambiguous information and the impact on products and process and to effectively communicate complex issues both verbally and in writing.
    • Strong communication skills with the ability to express oneself clearly and concisely to a variety of audiences. Ability to understand/analyze/synthesize and communicate to internal/external stakeholders.
    • Must be able to lead cross-functional and cross regional teams and deliver results in a matrix organization. Excellent organizational skills and ability to prioritize as well as Project Management abilities.
    • Willingness to travel to various meetings, including oversight trips
    • Requires approximately up to 10 % travel 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
      • Flexible Work Paths
      • Tuition reimbursement 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.

        Base Salary Range: $160,300 - $229,000, based on candidate professional experience level. Employees may also be eligible for Short Term and Long-Term Incentive benefits as well. Employees are eligible to participate in Medical, Dental, Vision, Life Insurance, 401(k), Charitable Contribution Match, Holidays, Personal Days & Vacation, Tuition Reimbursement Program and Paid Volunteer Time Off.

        This position is currently classified as "hybrid" in accordance with Takeda's Hybrid and Remote Work policy.

        In accordance with the CO Equal Pay Act, Colorado Applicants Are Not Permitted to Apply.

        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

        Cambridge, MA

        Worker Type

        Employee
        Worker Sub-Type

        Regular
        Time Type

        Full time

Keywords: Takeda Pharmaceutical, Lawrence , Director Global Regulatory Affairs, Audits, Inspections and Compliance, Accounting, Auditing , Lawrence, Massachusetts

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