Associate Director, Clinical & Quality Process Compliance

Role Summary

The Associate Director, Clinical & Quality Process Compliance is responsible for ensuring the quality of processes and product outputs. This role involves defining and specifying activities, processes, and standards to meet quality requirements, auditing and monitoring processes, and ensuring compliance with corporate and regulatory standards.

This role is located in Cambridge, MA and it is Hybrid (not remote). Relocation Benefit is available to support your transition.

Responsibilities

• Ensure compliance to Regulatory Intelligence Procedures by executing the regulatory intelligence process in partnership with functional compliance teams for regulations impacting Clinical, Safety and Clinical Pharmacovigilance Medical Quality (CPMQ) processes and procedures and determined by compliance to regulatory intelligence procedures.
• Ensures a robust communication plan is in place (including brief description of the new and or revised regulations the impact, any risks, mitigation plans, timelines) that enables knowledge sharing of regulatory intelligence insights and risks across CPMQ. Communicates to CPMQ periodically the progress of new and revised regulations and impact.
• Ensure implementation of change control and actions completed to address new and revised regulations. Oversees the review, completion and closure of routine and complex, impactful strategic clinical-related change controls and strategic Pharmacovigilance-related change controls.
• Provides data insights to emerging regulations and requirements, operational and compliance metrics and storyboards, identifies quality and compliance risks, and proactively provides strategic and tactical directions in the mitigation.
• Actively participate and contribute to enterprise-wide projects and initiatives, ensuring insights related to clinical and safety quality are considered.
• Enable a compliant quality system in safety and clinical trial delivery systems via CPMQ continual improvements projects. Actively participate and represent in continual improvement projects, related to safety and clinical trial delivery in partnership with GDO, PSPV, GRA etc. Review the outputs of the safety and clinical trial delivery redesigned processes and coordinate CPMQ colleague‚Äôs input.
• Provide CPMQ insights on continuous improvement that are enterprise-wide (ie Veeva, QMS, Enterprise Audit, etc.) to Global Quality and R&D Quality. Present to CPMQ at periodic intervals the status, insights and impact of projects impacting clinical and safety quality.
• Actively identifies key areas for process improvements and develop and execute plans according to timelines. Support the implementation of new and revised processes across CPMQ.
• Contributing to the design, implementation and advancement of the Clinical and Safety Quality Compliance strategy, model, and operations as a key member of the Leadership Team.

Qualifications

• 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.