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Job Description
At our heart we are committed colleagues. We offer interested people numerous opportunities and strongly believe in, and promote, diversity, equity, and inclusion. As a company we offer roles based on merit, welcoming candidates of any gender, age, religious belief, sexual orientation, race, color, ethnic or social origin, or disability.
Our team is growing and for this we need bright minds with creativity and flexibility - what talent do you have?
OBJECTIVES/PURPOSE:
Provides strategic quality oversight activities to strategic business partners, clinical suppliers including early phase clinical trial units, clinical central and specialty laboratory suppliers, medical suppliers, and pharmacovigilance (PV) suppliers that promotes operational and compliance excellence, quality risk management and knowledge management.
Oversees and ensures the timely and compliant tactical execution of the Clinical, Safety and Supplier Quality (CSSQ) audit program, providing GCP, GCLP, and GVP quality assurance expertise as related to supplier audits.
Establishes and maintains a partnership with internal stakeholders understanding Takeda’s business priorities and needs with the business partners and suppliers and communicating actionable insights from the CSSQ audit program.
Reports to and acts as a strategic thought partner to the Head of Business Partner and Supplier Quality in developing and implementing CSSQ strategic and tactical building capabilities within the CSSQ organization and in ensuring alignment with the Clinical, Pharmacovigilance and Medical Quality’s vision.
ACCOUNTABILITIES:
Executes strategic quality oversight activities of business partners, clinical suppliers including early phase I clinical trial units, clinical central and specialty laboratory suppliers, medical suppliers, and pharmacovigilance (PV) suppliers through the supplier qualification and routine supplier audits.
Contribute to the development of the strategic audit plan through revaluation of audit frequency, supplier categorization and idenification of risk factors.
Maintains the regular reporting of relevant audit metrics, key risk quality indicators to enable proactive oversight and continuous improvement of the CSSQ audit program.
Mitigates, communicates, and escalates any risks flagged by the audit metrics and key quality indicators, ensuring actions are commensurate to the risk and are timely.
Develop bi-annual data trending insights, analyze, and synthesize the risks associated with the data to identify trends and inform the supplier audit program.
Drives the operational activities of strategic and tactical level CSSQ risk-based audit program (i.e., update/identify risk to the annual program, assignments to junior staff, allocation of auditee candidates to consultant auditor firms, ensure qualification of auditors, monitor audit & CAPA metrics and ensure any risks are communicated to the Head of Business Partner and Supplier Quality).
Escalates the quality event investigation/deviation management and the communication of critical and major compliance risks to Head of Business Partner and Supplier Quality in compliance with Takeda procedures, policies and regulatory guidance
Execute individual supplier audits to include the scheduling, planning, preparations, conduct, reporting, and CAPA management through audit closure.
Contribute to the review of the clinical study vendor list for study execution teams,, quality agreement for strategic suppliers, as appropriate.
Facilitate systemic quality event investigations relevant to business partners and suppliers that impact the clinical trial…