Compliance Operations Lead, Associate Director

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Job Description

OBJECTIVES:

• Ensures Global and R&D Quality processes are embedded and effectively implemented across CPMQ
• Partner with teams across CPMQ to proactively assess the needs for functional processes and system enhancements
• Lead the development of internal functional processes and training and ensure alignment with global processes and regulatory requirements and expectations.
• Drive the implementation and change management of processes and systems across CPMQ
• Create mechanism to monitor the health of the QMS including the identification of systematic quality compliance risks and implementation of robust mitigation plans
• Engage with CPMQ teams to foster a culture of learning and continuous improvement
• Lead CPMQ continuous improvement initiatives to enable optimization of 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.

ACCOUNTABILITIES:

• Leads 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 the identification of systematic quality compliance risks and implementation of robust mitigation plans
• Ensure maintenance of the dashboards to monitor the health of the QMS and proactively monitor and share across CPMQ the compliance metrics for CPMQ activities e.g. audit, inspection, QE, CAPA.
• Organise 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 learnt 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 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)

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:

• 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 in 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 message. 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.

PHYSICAL DEMANDS:

• Routine demands of an office-based environment

TRAVEL REQUIREMENTS:

Willingness to travel to various meetings, including overnight trips. Some international travel may be required.

Takeda Compensation and Benefits Summary

We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.

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EEO Statement

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, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.

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Job Exempt