21 days old

Pharmacovigilance Quality Compliance - Associate Director (Open)

Takeda Development Center Americas, Inc.
Cambridge, MA 02139
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Job Description

Pharmacovigilance Quality Compliance - Associate Director (Open)

Are you looking for a patient-focused, innovation-driven company to inspire you and empower you to shine? Join us as a Associate Director, GVP Inspection Readiness at our Zurich location.

Here, you will be a vital contributor to our inspiring, bold mission.

You will contribute to Takeda's mission across multiple projects in a goal-oriented, timeline-driven, and dynamic work environment, while ensuring quality and accuracy. A typical day will include:

In this role, your purpose will be to

  • Provide strategic quality oversight to the pharmacovigilance inspection program that promotes operational and compliance excellence, quality risk management and knowledge management.
  • Maintain a state of control by implementing monitoring and control systems that ensures the quality systems supporting the PV system is robust and aligned with applicable regulations
  • Partner with the different functions across the globe that affect the PV system in identifying quality and compliance risks, conducting investigations and developing adequate corrective and preventive actions (CAPAs), managing changes and facilitating continuous improvement that is in consideration of Takeda's values and priorities.
  • Report to and act as a strategic advisor to the Head of PVMQ Compliance in developing and implementing PVMQ Compliance strategies, in managing the operational activities of and building capabilities within the PVMQ Compliance function and in ensuring alignment with the PV & Medical Quality vision.
  • Lead the pharmacovigilance system inspection readiness program, including the development and implementation of a strategy. Engage with relevant departments and partners to ensure inspection readiness, driving accountability and transparency. Functions include, but not limited to, Global Patient Safety Evaluation compliance groups, Global Regulatory Affairs Compliance, GCP Process Excellence, Compliance and Inspection Strategy, Legal, etc.
  • Provide insights to latest regulations and requirements, operational and compliance metrics and storyboards, identify quality and compliance inspection risks, and provide strategic directions in the mitigation.
  • Host PV inspections, and provides strategic direction to relevant departments and Subject Matter Experts (SME). May also host and manage business partner audits.
  • Ensure a robust communication plan is in place, that enables knowledge sharing of insights and risks. Communicate the progress of inspections daily, summarizing the inspection activities and potential observations and mitigation activities.
  • Lead the inspection response activities, ensuring the responses are adequate, reviewed and approved internally by the relevant stakeholders, at the right levels and submitted on time. Review and provide input to response to ensure the impact is thoroughly assessed, appropriate root cause is identified, and specific, measurable, achievable, relevant and timebound CAPAs are developed.
  • Oversee the completion and closure of inspection CAPAs, ensuring that no inspection CAPAs are late. Mitigate and escalate any risks. Ensure appropriate effectiveness checks are developed for relevant inspection CAPAs. Provide input to the effectiveness check plans, and reviews and approve outcome.
  • Be a Subject Matter Expert (SME) on the PVMQ Compliance activities including deviation management, quality investigation, corrective and preventive actions (CAPA) management and oversight and change control. Represent PVMQ Compliance in these topics in inspections.
  • Support and provide relevant guidance to other non-PV specific inspections (e.g., GMP, GCP, etc).
  • Lead complex quality investigations affecting the pharmacovigilance systems. Provide Quality Leadership for other quality investigations ensuring the right partners are engaged in impact assessment, root cause analysis and CAPA development.
  • Develop lessons learned from on regulatory inspections, business partner audits and quality investigations.
  • Promote knowledge management.
  • Lead cross-functional continual improvements projects that enable a compliant quality systems in the pharmacovigilance systems.
  • Review and approve controlled procedures related to pharmacovigilance to ensure regulatory and past inspection commitments are considered.
  • Provide input in the pharmacovigilance agreement (PVAs) templates - sharing of inspection and audit findings, etc. Escalation point for any QA-relevant PVA challenges.
  • Coach junior Compliance staff to support capability building and talent development.
  • Escalate issues of potentially critical non-compliance and/or lack of urgency in remediation to senior management.
  • Analyse results, quality issues and investigation to identify actionable trends and to promote a state of compliance.
  • Develop and monitor relevant metrics and Key Performance/Quality Indicators (KPI/KQI) for the services provided - inspections -
  • Mitigate, communicate and escalate any risks flagged by the metrics and KPIs/KQIs, ensuring actions are commensurate to the risk and timely.
  • Drive the development and execute the strategy to understand the health of the PV system (i.e. risk register, KPIs).
  • Contribute to any relevant quality and compliance governance in Takeda, including the PV Compliance Metrics Oversight Committee (CMOC) and the Clinical & Safety Quality Council, communicating any quality or compliance risks and opportunities, improvements and successes.
  • Partner within PVMQ and R&D Quality and with other pharmacovigilance and medical functions to ensure alignment on both quality and business objectives.
Education and behavioral skills:
  • BSc in a scientific or allied health/medical field (or equivalent degree).
  • Minimum of 10 years of increasing responsibility and relevant experience in the global pharmaceutical industry, with at least 5 years of experience in GCP/GVP Quality/Compliance.
  • Profound knowledge of pharmaceutical development, medical affairs and GCP/GVP regulations including FDA, EU, MHRA, PMDA and ICH.
  • Experience must include successful development and implementation of a clinical or pharmacovigilance audit program, hosting/leading regulatory inspections and remediation activities on a global level.
  • Experience managing complex organizational compliance issues and in identifying and implementing organization-wide compliance initiatives.
  • Experience with managing global, cross-functional projects.
  • Fluency in written and spoken English, additional language skills a plus.

What Takeda can offer you:

  • Hybrid mode of working
  • 28 working days of vacation per calendar year + 4 floating paid days off set up by our company
  • 16 weeks of paid parental leave and possibility of unpaid leave, following the birth or adoption of their child
  • Other benefits including lunch card, transportation contribution, attractive pension plan, and many others.
  • Professional training and development opportunities

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.

Empowering Our People to Shine

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.


Cambridge, MA

CHE - Glattpark (Opfikon) - Zurich HQ

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Time Type

Full time

Posted: 2022-09-09 Expires: 2022-10-08
Sponsored by:
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Sponsored by:
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Pharmacovigilance Quality Compliance - Associate Director (Open)

Takeda Development Center Americas, Inc.
Cambridge, MA 02139

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