Job Description
Director/ Executive Director, PV QMS Lead - Safety & Pharmacovigilance Job Category: Development - Ionis
Requisition Number: IONIS003541
Posted: January 11, 2025
Full-Time
Locations Headquartered in Carlsbad, California, and with offices in Boston, Massachusetts, and Dublin, Ireland, Ionis has been at work for more than three decades discovering medical breakthroughs that have redefined life for people with serious diseases. We are pioneers in RNA-targeted medicines, and our platform continues to revolutionize drug discovery and transform lives for patients with unmet needs.
At Ionis, we pride ourselves on cultivating a challenging, motivating and rewarding environment that fosters innovation and scientific excellence. We know our success is a direct result of the exceptional talent and dedication of our employees.
With an unprecedented opportunity to change the course of human health, we look to add diverse individuals, skill sets and perspectives to our exceptional team. We continue to invest time, money, and energy into making our onsite and remote work environments a place where solid and lasting relationships are built and where our culture and employees can thrive.
SUMMARY:
The Director/Executive Director, PV QMS Lead would be responsible for all activities related to the Pharmacovigilance Quality Management System oversight as well as audit and inspection readiness globally. This individual will lead Compliance & Training within the Safety/PV team and cross-functionally to drive global compliance. This resource will also provide strategic input and tactical implementation for Pharmacovigilance activities and projects, identify and communicate compliance risks, oversee action plans to mitigate those risks and lead, oversee and develop the highest level of operational excellence of corrective and preventative action deliverables to ensure timely compliance. This position reports to the VP and Head of Safety & PV Dept.
RESPONSIBILITIES:
Responsible for executing and overseeing global PV compliance and PV quality oversight for all aspects of the global Quality Management System (QMS) including Deviations, CAPAs, and KPIs.
Collaborate/support the Global Quality team (both clinical and commercial QA) with inspection activities (mock interviews, SME identification, and post inspection responses submitted to the Health Authorities) such as FDA, EMA, MHRA, HPRA, and Health Canada inspections.
Collaborate with external contributors in Global Regulatory Compliance, Global Regulatory Affairs, Global Drug Development, Commercial, Market Research, Legal and other cross-functional teams.
Support and collaborate with the QPPV and deputy QPV to ensure the business is compliant with regulatory requirements.
Oversee the planning, execution, and delivery of CAPA strategies/plans for the remediation, correction, and prevention of recurrence of those significant quality events with broader impact across the Ionis PV QMS.
Lead and guide internal audits and Inspection-related Corrective and Preventative Actions (CAPA).
Lead investigation of large-scale significant quality events, including the identification of issues, impact assessment, root cause analysis, and oversight of appropriate communication.
Maintain appropriate level of expertise in US and international GCP/GLP/PV regulatory requirements, policies, SOPs, and unit/project-specific procedures within Ionis applicable to the processes and systems within the scope of the PV QMS.
Lead and ensure timely PV training.
Lead discussions and determine appropriate KPIs across the whole PV organization leveraging best industry benchmarks.
Develop and execute analytical and tactical strategies aligned to business projects, milestones, and policies to ensure their timely delivery.
Develop and lead the maintenance of global Key Performance Indicators (KPIs).
Develop, implement, and maintain reporting of metrics that enable the monitoring and optimization of effectiveness, including dashboard and/or standard reports and Scorecards.
REQUIREMENTS:
Master’s degree in life sciences (e.g. BSN, MSN, PhD, PharmD, Master’s in Health Law/Regulatory & Compliance or BS in Life sciences with at least 10 years of experience).
At least 10 years of experience post qualification.
High level of competence, with an ability to balance this with industry standards to achieve business goals.
A thorough knowledge of the pharmaceutical/biopharmaceutical industry, especially clinical research and global regulatory requirements, QA and practices governing expedited and periodic safety reporting, signal generation, safety evaluation, and risk management activities.
Able to work across therapeutic areas and functions.
Works collaboratively (establishes shared purpose across boundaries).
Proven experience as a Project Manager with PMP or similar project management certification is a plus.
Ability to manage multiple projects simultaneously and prioritize tasks effectively.
Ionis offers an excellent benefits package!
The pay scale for this position is $184,000 to $239,000.
NO PHONE CALLS PLEASE. PRINCIPALS ONLY.
Ionis Pharmaceuticals, Inc. and all its subsidiaries are proud to be EEO employers.
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Job Tags
Full time, Remote job,