at Takeda Pharmaceuticals in Springfield, Illinois, United States
Job Title: Senior Quality Manager, Pharmacovigilance Auditing
Job Location: Zurich, Switzerland/Cambridge, MA
About the role:
As the Senior Quality Manager, Pharmacovigilance Auditing, you will contribute to strategic quality oversight activities of PV business partners and suppliers that promote operational and compliance excellence, quality risk management and knowledge management. You will support senior management with the strategic quality oversight activities of partners and suppliers through the review of controlled procedures and templates related to PV business partner and supplier activities including PVAs, Quality Agreements, and Quality Plans to ensure regulatory and past inspection commitments are considered. You will report to the Head Business Partner & Supplier Quality – Pharmacovigilance Medical Quality.
How you will contribute:
+ Perform pharmacovigilance and quality management system auditing, project management and operational knowledge of an audit program and management of the daily priorities of the BPSQA audit program by problem solving, addressing complex challenges, identifying risks, escalating issues to senior management, communicating expectations to internal and external stakeholders, and onboarding junior staff while understanding Takeda’s priorities with the partners and suppliers
+ Conduct end-to-end audit operations and ensures the timely and compliant execution of the BPSQA audit program by providing pharmacovigilance and quality assurance expertise
+ Contribute to the development and implementation of BPSQA audit program and be a delegate to the BPSQA Lead to support partnerships by understanding our priorities along with partners and suppliers to communicate insights from the BPSQA audit program and vendor quality management and oversight forum
+ Assist senior management with systemic quality event investigations relevant to business partners and suppliers that impact the pharmacovigilance system in identifying quality and compliance risks, contributing to robust investigations and assisting with adequate corrective and preventive actions (CAPAs) development, ensure continual improvement that is in consideration of Takeda’s values and strategic priorities in collaborate with different functions across the globe
+ Provide input across R&D Quality functions to support the consultant auditor framework, supplier qualification activities, cross functional initiatives, process improvement initiatives and participate in complex compliance projects and act as the BPSQA point of contact to consultant auditor firms
+ Launch operational level activities for audit preparation, scheduling, audit scope, audit sampling, audit planning, audit conduct, audit response report and CAPA plan development of individual PV routine, qualification or directed audits to manage risks
+ Oversee the accuracy and management of audit data and closure of CAPAs and Effectiveness Checks within the audit management system
+ Contribute input to the strategic and tactical level BPSQA risk-based audit program and communicate the updates to the annual program and ensure any risks are communicated to the Head of BPSQA
+ Contribute to the relevant metrics and Key Performance/Quality Indicators (KPI/KQI) of the BPSQA audit program. Mitigates, communicates, and escalates any risks flagged by the metrics and KPIs/KQIs, ensuring actions are commensurate to the risk and timely. and ensure any risks are communicated to the Head of BPSQA.
+ Provide pharmacovigilance and quality assurance expertise and support inspections and business partner audit activities by engagement with internal/external stakeholders about inspection/audit deliverables, timely notifications, and communications and document requests
+ Support cross-functional continual improvements projects that allow compliant quality systems in the pharmacovigilance systems.
+ Partner with senior management to develop audit standardized functional tools and processes (internal request documents, audit plans, audit agenda and audit questionnaire templates), lead the peer review of audit report, interface with lead auditor to resolve and/or address audit report changes
What you bring to Takeda:
+ BSc in a scientific or allied health/medical field (or equivalent degree).
+ 7 years of increasing responsibility and relevant experience in the global pharmaceutical industry, with at least 5 years of experience in GCP/GVP Quality/Compliance.
+ Experience in pharmaceutical development, medical affairs and GCP/GVP regulations including FDA, EU, MHRA, PMDA and ICH.
+ Advance knowledge in strategic and non-strategic supplier quality oversight
+ Experience includes successful development and implementation of a pharmacovigilance audit program, hosting/leading business partner audits and remediation activities on a global level.
+ Experience managing complex organizational compliance issues and in identifying and implementing organization-wide compliance initiatives.
+ Experience managing global, cross-functional projects.
+ Demonstrated proficiency in negotiation and conflict resolution with stakeholders.
+ Fluency in written and spoken English
+ Ability to travel 20%
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:
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, or any other characteristic protected by law.
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