Compliance Operations Lead, Associate Director
Vor 6 Tagen
We are seeking a highly skilled Compliance Operations Lead, Associate Director to join our team at Takeda. This role will be responsible for ensuring the effective implementation of Global and R&D Quality processes across CPMQ.
Key Responsibilities- Partner with teams across CPMQ to assess needs for functional processes and system enhancements.
- Lead the development of internal functional processes and training, ensuring alignment with global processes and regulatory requirements.
- Drive the implementation and change management of processes and systems across CPMQ.
- Create mechanisms to monitor the health of the QMS, including identifying systematic quality compliance risks and implementing robust mitigation plans.
- Engage with CPMQ teams to foster a culture of learning and continuous improvement.
- Lead CPMQ continuous improvement initiatives to optimize clinical and safety quality compliance activities.
- Provide expert advice and support to the CPMQ team on quality compliance activities.
- Partner with Global Quality, R&D Quality teams, and contribute to enterprise-wide solutions.
- Lead and create simplified End-to-End functional processes and tools to enable execution of CPMQ activities, ensuring alignment with global processes and regulatory requirements.
- Create and deliver training solutions to support the learning and implementation of functional processes and systems.
- Create and implement change management plans for new and revised CPMQ processes and systems.
- Manage the CPMQ training curriculum and ensure training is assigned to the appropriate CPMQ team.
- Lead and embed the process for collating, trending, and interpretation of quality data for actionable insights, including identifying systematic quality compliance risks and implementing robust mitigation plans.
- Ensure maintenance of dashboards to monitor the health of the QMS and proactively monitor and share compliance metrics for CPMQ activities.
- Organize Clinical and Pharmacovigilance Quality council meetings and proactively manage the agenda and ensure key priority topics and presentations are captured and effectively communicated.
- Ensure that risks captured on the CPMQ risk register are evaluated and escalated to the Quality council and RDQ LT as applicable.
- Drive the implementation of the lessons learned framework across CPMQ.
- Provide expert guidance to the CPMQ team on quality compliance activities.
- Provide guidance and support to GCP, PV Health Authority inspections, including logistics.
- Present insights to the health of the QMS to CPMQ and to our stakeholders.
- Represent CPMQ in Global Quality/R&D Quality process and system improvement initiatives.
- Engage, share, and embed best practices into learning opportunities across CPMQ teams and evaluate the need for new/revised processes, tools, and training solutions.
- Act as Steward of the QMS within CPMQ (e.g., Quality Events, Serious Breach, Change Control, Risk Register, Regulatory Intelligence, Gap Assessment, Audits, Inspections, CAPA, SOP management, training assignment, etc.).
- BSc in a scientific or allied health/medical field (or equivalent degree).
- Minimum of 7 years of increasing responsibility and relevant experience in the global pharmaceutical industry in functions such as Clinical Operations, Data Management and Statistics, with at least 3 years of experience in GCP 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, investigations, and remediation activities on a global level.
- Experience in managing complex organizational compliance issues and identifying and implementing organization-wide compliance initiatives.
- Skilled in managing global, cross-functional projects.
- Successful management of business transformation/change management initiatives, e.g., quality system integration, outsourcing strategy, etc.
- Excellent communication skills to convey messages. Exceptional active listening skills to understand the needs and concerns of others, which is crucial for finding win-win solutions.
- Outstanding ability to apply critical thinking and problem-solving abilities to address challenges and advocate for solutions.
- Demonstrated ability to succinctly translate and effectively communicate the potential impact of significant and complex issues.
- Fluency in written and spoken English, additional language skills a plus.
- Routine demands of an office-based environment.
Willingness to travel to various meetings, including overnight trips. Some international travel may be required.
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