16 days old

Associate Director, Global Patient Safety Evaluation - Compliance Audits & Inspection Readiness

Millennium Pharmaceuticals, Inc.
Boston, MA 02109
  • Job Code
    R0026282

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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 Associate Director, GPSE Compliance Audits & Inspection Readiness in our Cambridge, Massachusetts office.

Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As an Associate Director, GPSE Compliance Audits & Inspection Readiness professional working in the Medical Safety Team, you will manage all aspects of inspection and audit-related activities within Global Patient Safety Evaluation (GPSE) for assigned audits/inspections, under the guidance and oversight of the GPSE Compliance Team Lead, Audits & Inspection Readiness. A typical day will include:

OBJECTIVE:

The Associate Director, GPSE Compliance Audits & Inspection Readiness will:

  • Interface and collaborate with various stakeholders including but not limited to the GPSE Subject Matter Experts (SMEs), GPSE PV Affiliates Relations (PVAR) Compliance & Process Lead, GPSE Compliance vendors, and R&D QA, pre-, during, and post- audits and inspections, to support preparation activities, fulfillment of audits and inspection requests for GPSE, and responses to observations.
  • Support compliance-related activities, as needed such as the coordination of Quality Events (QEs), Corrective and Preventive Actions (CAPAs), Effectiveness Checks (ECs), and the monitoring of GPSE compliance metrics.
  • Maintain current knowledge of relevant PV regulations, including evolving changes in the regulations that may impact compliance.
  • Manage special compliance-related projects, as assigned

Principal responsibilities include:

  • Lead audit/inspection activities within GPSE for assigned audits/inspections:
    • Serve as the primary representative within GPSE for the preparation and coordination of audits and inspections.
    • Coordinate and manages audit and inspection requests within GPSE and ensures that appropriate responses and requested documents are provided in a timely manner.
    • Coordinate and manage the development and review of responses to GPSE audit findings and inspections.
    • Collaborate with other inspection management leads outside of GPSE and quality/compliance/inspection readiness colleagues for activities related to audits and inspection preparation.
    • Evaluate inspection reports from various sources and monitors trends in health authority inspection activities to proactively identify potential gaps and/or areas of risks to be addressed within GPSE.
    • Liaise with relevant functional teams within GPSE to promote a culture of compliance, and continuous quality/process improvements based on inspection observations.
    • Supports compliance-related activities, as needed
    • Coordination of Quality Events (QEs), Corrective and Preventive Actions (CAPAs), Effectiveness Checks (ECs)
    • Monitoring of GPSE compliance metrics

ACCOUNTABILITIES:

  • Manage day-to-day activities related to audits and inspections readiness within GPSE.
  • Serve as the primary GPSE Compliance point of contact for the coordination of assigned GPSE audits and inspections, and liaises with the responsible GPSE Subject Matter Experts to ensure that audits and inspections requests are appropriately and timely fulfilled.
  • Review audit and inspections responses to requests to ensure quality and adequacy prior to providing to QA for final QC. Coordinates and contributes to strategic discussions, as needed.
  • Coordinate and manages the development and review of post-inspection responses to GPSE findings.
  • Maintain current knowledge of relevant PV regulations, including evolving changes in the regulations that may impact compliance.
  • Evaluate inspection reports from various sources and monitors trends in health authority inspection activities to proactively identify potential gaps and/or areas of risks to be addressed within GPSE
  • Support compliance-related activities, as needed
  • Coordination of Quality Events (QEs), Corrective and Preventive Actions (CAPAs), Effectiveness Checks (ECs)
  • Monitoring of GPSE compliance metrics
  • Manages special compliance-related projects, as assigned

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:

  • Bachelor of Science degree in medical or science related field; post-graduate degree or equivalent a plus.
  • Experience in the pharmaceutical industry with at least 5 years of relevant experience in pharmacovigilance compliance and audits and inspections.
  • Knowledge of FDA/EU regulations, and ICH guidelines for GVP and GCP with practical experience in the interpretation and implementation of PV regulations. Ability to interpret PV regulations, analyze gaps, and identify opportunities for improvement within GPSE.
  • Experience with quality management systems (e.g., Trackwise) a plus
  • Ability to work and collaborate in a global environment with cross-functional teams, with good interpersonal skills, assertiveness, and team spirit.
  • Ability to manage both time and priority constraints, and manage multiple priorities simultaneously, with strong attention to detail in establishing priorities and meeting deadlines.
  • Ability to lead teleconferences and meetings.
  • Ability to work independently, take initiative, and complete tasks while keeping management updated.
  • Good analytical/judgment capabilities to understand/analyze/synthesize and communicate
  • Ability to identify and resolve conflicts with direction from management
  • Excellent interpersonal, communication, and organizational skills.
  • Excellent level of computer literacy with Microsoft applications

WHAT TAKEDA CAN OFFER YOU:

  • 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

Learn more at takedajobs.com

#LI-JV1

Locations

Boston, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time





Posted: 2021-01-06 Expires: 2021-02-04
Sponsored by:
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Sponsored by:
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Associate Director, Global Patient Safety Evaluation - Compliance Audits & Inspection Readiness

Millennium Pharmaceuticals, Inc.
Boston, MA 02109

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