Are you looking for a patient-focused, innovation-driven company that will 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.
In this role, you will contribute to Takeda’s mission by having the ability to lead effectively and work concurrently across multiple projects in a goal-oriented, timeline-driven, and dynamic work environment, while ensuring quality and accuracy. A typical day will include:
- Provides strategic quality oversight to the pharmacovigilance inspection program that promotes operational and compliance excellence, quality risk management and knowledge management.
- Maintains a state of control by implementing effective monitoring and control systems that ensures the quality systems supporting the PV system is robust and aligned with applicable regulations
- Partners with the different functions across the globe that impact the PV system in identifying quality and compliance risks, conducting robust investigations and developing adequate corrective and preventive actions (CAPAs), managing changes and facilitating continual improvement that is aligned to Takeda’s values and strategic priorities.
- Reports to and acts as a strategic thought partner 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.
- Leads the pharmacovigilance system inspection readiness program, including the development and implementation of a strategic plan. Engages with relevant functions and stakeholders 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.
- Provides insights to emerging regulations and requirements, operational and compliance metrics and storyboards, identifies quality and compliance inspection risks, and proactively provides strategic and tactical directions in the mitigation.
- Hosts PV inspections, and provides strategic direction to relevant functions and Subject Matter Experts (SME). May also host and manage business partner audits.
- Ensures a robust communication plan is in place, that enables knowledge sharing of insights and risks. Communicates the progress of inspections on a daily basis, summarizing succinctly the inspection activities and potential observations and mitigation activities. Effectively and timely escalates to management.
- Leads and manages 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. Reviews and provides 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.
- Oversees the completion and closure of inspection CAPAs, ensuring that no inspection CAPAs are late. Mitigates and escalates any risks. Ensures appropriate effectiveness checks are developed for relevant inspection CAPAs. Provides input to the effectiveness check plans, and reviews and approves outcome.
- Acts as 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).
- Leads complex quality investigations impacting the pharmacovigilance systems. Provide Quality Leadership for other quality investigations ensuring the right stakeholders are engaged in impact assessment, root cause analysis and CAPA development.
- Develop lessons learned from on regulatory inspections, business partner audits and quality investigations.
- Promotes knowledge management.
- Leads 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 issues/challenges.
- Coach junior Compliance staff to support capability building and talent development.
- Escalates issues of potentially critical non-compliance and/or lack of urgency in remediation to senior management.
- Analyses results, quality issues and investigation to identify actionable trends and to promote a state of compliance.
- Develops and monitors relevant metrics and Key Performance/Quality Indicators (KPI/KQI) for the services provided - inspections --. Mitigates communicates and escalates any risks flagged by the metrics and KPIs/KQIs, ensuring actions are commensurate to the risk and timely.
- Drives the development and executes the strategy to understand the health of the PV system (i.e. risk register, KPIs).
- Contributes 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, continual improvements and successes.
- Partners within PVMQ and R&D Quality and with other pharmacovigilance and medical functions to ensure alignment on both quality and business objectives.
EDUCATION, BEHAVIOURAL COMPETENCIES AND 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.
Advanced 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 in managing complex organizational compliance issues and in identifying and implementing organization-wide compliance initiatives.
Skilled in managing global, cross-functional projects.
Fluency in written and spoken English, additional language skills a plus.
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.
At Takeda, we are transforming the pharmaceutical industry through our R&D- driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global 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
AUT - Vienna - Kärntner Ring