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 pha