Associate Director, GCP and GCP Supplier Quality Lead
Takeda · Warsaw · PLN 328,000–PLN 451,000 (stated in the posting)
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 delivery, medical suppliers, and/or the PV 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 aligned to Takeda’s values and strategic priorities in collaborate with different functions across the globe.
- Reports, escalates any significant compliance risks and issues to the Head of Business Partner and Supplier Quality , Clinical Safety and Compliance Quality, and Clinical, Pharmacovigilance and Medical Quality’s Leadership Team, when necessary.
- Serve as the GCP, GCLP, and GVP quality assurance expert to review the audit language in clinical suppliers including early phase I clinical trial units, clinical central and specialty laboratory suppliers, medical suppliers, and pharmacovigilance contracts, Market Research and Patient Support Programs contracts, and Business Partner Pharmacovigilance Agreements (PVAs) to ensure compliance with Takeda policies and procedures and regulatory guidance.
- Provides clinical, PV, medical, and quality assurance expertise and POC for internal audits, cross sub functional group audits across the RD &Quality business, inspections and business partner audit activities by the presentation of CSSQ risk-based audit program, engagement with internal/external stakeholders about inspection/audit deliverables, quality control of document requests, timely notifications, and communications and document requests.
- Collaborates 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 CSSQ point of contact to consultant auditor firms
- In collaboration with the Head of Business Partner and Supplier, manage the contract updates and partnership relationship with CSSQ consultant supplier audit firms.
- Provide direction to junior staff on robust audit operational activities and the development of adequate audit responses, CAPA plan, Effectiveness Checks and management review and approval of audit reports. Support junior staff with understanding complex audit findings and/or challenges with audit preparations and audit reports.
- Coaches junior CSSQ staff to support capability building and talent development through onboarding and mentoring
- Contributes as an GCP, GCLP, and GVP SME for specific change control procedures involving strategic or non-strategic suppliers to ensure compliance of the change control with applicable QMS requirements, Takeda policy and procedures and regulatory guidance
- Contributes as an GCP, GCLP, and GVP SME for procedural gap assessments involving process improvements.
- Promotes knowledge management and develop lessons learned to enhance the CSSQ supplier audit program.
- Lead cross-functional continual improvements projects that enable a compliant quality systems in the pharmacovigilance systems.
- Review and approve controlled procedures and templates related to clinical, medical and PV business partner and supplier oversight activities including PVAs, etc., to ensure regulatory and past inspection commitments are considered.
- Escalates issues of potentially critical non-compliance and/or lack of urgency in remediation to senior management. Analyzes results, quality issues and investigation to identify actionable trends and to promote a state of compliance.
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/GCLP/GVP Quality/Compliance.
- Proven track record in managing complex projects across multiple cross functional teams and leading comprehensive quality initiatives.
- Champion a culture of quality and compliance across the organization through training, communication, and role-modeling.
- Advanced knowledge of pharmaceutical clinical trial development, PV, medical affairs and GCP/GCLP/GVP regulations including FDA, EU, MHRA, PMDA and ICH.
- Advance knowledge in strategic supplier quality oversight.
- Experience must include successful development and implementation of a clinical, medical or pharmacovigilance audit program
- Experience in managing complex organizational compliance issues and in identifying and implementing organization-wide compliance initiatives.
- Skilled in managing global and cross-functional projects.
- Excellent communication and interpersonal skills with the ability to communicate complex information.
- Proven abilities to promote shared responsibilities across teams.
- Proven critical thinking skills to drive solutions while exercising a sense a urgency.
- Demonstrates ability to share knowledge and expertise with senior managers to support senior managers development.
- Fluency in written and spoken English, additional language skills a plus.
Locations
Warsaw, Poland
Base Salary Range:
zł 328,000.00 - zł 451,000.00
For information about our benefits, please click here.