Assistant Director/ Associate Director, GCP & GVP Development Quality Assurance
Ionis Pharmaceuticals, Inc.
Ionis Pharmaceuticals, Inc., is headquartered in Carlsbad, California, with offices in Boston, Massachusetts, and Dublin, Ireland. For more than 30 years, Ionis has been the leader in RNA-targeted therapy, pioneering new markets and changing standards of care with our novel antisense technology. Ionis currently has three marketed medicines and a premier late-stage pipeline highlighted by industry-leading cardiovascular and neurological franchises. Our scientific innovation began and continues with the knowledge that sick people depend on us, which fuels our vision to become the undisputed leader in genetic medicine, utilizing a multi-platform approach to discover, develop and deliver life-transforming therapies.
As the first company to fully harness the power of RNA technology for human therapeutics, Ionis’ platform continues to revolutionize drug discovery and transform lives for patients with unmet needs. We are building upon our innovative research and drug development excellence to provide greater value to patients, and we are well positioned financially to deliver on our strategic goals.
Ionis is a challenging, motivating and rewarding environment designed to foster innovation and scientific excellence. Our success is a direct result of our outstanding employees. We are interested in bringing together a diverse group of individuals with different skill sets and perspectives into this creative environment to be part of a productive and inclusive team. While acknowledging people are actively engaged in hybrid/remote work, we continue to invest time, money, and energy into making our workplace locations a place where our culture and employees can thrive. We believe engaging on a day-to-day basis, in person, builds solid and lasting relationships, and contributes positively to our culture and innovation. From the heart of our stunning Carlsbad campus, we aim to provide a central connection point for all our employees. These facilities give us the opportunity to connect cross-functionally, collaborate and to build on the success of our business as we continue to grow. Join us and experience our unique culture while you develop and expand your career.
ASSISTANT DIRECTOR / ASSOCIATE DIRECTOR, GCP & GVP - DEVELOPMENT QUALITY ASSURANCE
We are seeking a highly motivated individual to join as an Assistant Director / Associate Director, Development Quality Assurance to ensure the quality and compliance of Ionis-sponsored clinical trials and pharmacovigilance activities with respect to Ionis’ Standard Operating Procedures, applicable regulatory requirements (FDA, EU, ICH & country specific), and current industry standards and practices.
Audit Planning, Conduct, Reporting, and Follow-up
- Perform QA risk assessments & contribute to maintaining a comprehensive GCP/GVP risk-based audit program.
- Conduct and/or coordinate internal and external (both domestic and international) GCP & GVP audits.
- Lead/perform for-cause audits or other high-profile audits, projects, and/or special investigations to evaluate non-compliance, root cause identification, and report results to leadership
- Review and/or prepare timely well-written audit reports and communicate findings to auditees, cross-functional representative, and management
- Assess/review audit report responses and ensure the corrective and preventative action (CAPA) plans adequately address findings and root causes, including effectiveness checks where appropriate
- Review/evaluate and maintain/track CAPAs and follow-up with stakeholders to ensure actions are completed
Health Authority Inspection Planning, Preparation, Management, and Follow-up
- Leads and/or supports global regulatory agency inspections (end to end) and other audits.
- Ensure creation/maintenance of documents for pre-inspection preparation
- Oversee/conduct/coordinate training for defined SMEs and ensure setup of pre-inspection preparation meetings for line unit heads and appropriate staff
- Lead/contribute to the assessment of reports and results from Health Authority inspections. Including the associated risks and recommendations, for provision to relevant leadership
- Oversee/participate in the preparation of final response documents for Site Inspections, Sponsor/Monitor, and/or MAH Inspections
- Lead/collaborate with other Development QA team members to complete inspection follow-up activities within and outside the department, as needed
- Oversee/ensure tracking/maintenance of QA-managed Health Authority Inspection data
Clinical Program/Study Quality Support, Consultancy, and Other
- Mentor, support, and/or manage the activities of internal & external Development QA personnel.
- Maintain ongoing awareness of program/study issues related to quality, safety, and efficacy
- Provide quality oversight and consultation at the program/study level, as needed, to ensure GCP and/or GVP quality and compliance.
- Provide risk identification/mitigation support for potential or identified quality issues
- Appropriately escalate any quality/compliance issues to relevant leadership
- Leverage audit/inspection trends and other information sources to support data-driven audit planning and optimize clinical trial quality and compliance via stakeholder education and consultation
- Identify, develop, and report metrics for management review and GCP/GVP activities that will form the basis for continuous improvement practices and processes.
- Assist in the review of GCP/GVP and systems related SOPs to assess their adherence to applicable regulatory standards and corporate goals.
- Define, implement, and/or lead GCP/GVP QA and/or company/cross functional yearly goals and initiatives as assigned.
- Coordinate development, maintenance, and delivery of GCP/GVP training programs.
- Stay current with new or revised regulations and other regulatory intelligence.
- Act as QA contact for vendor or partner QA-QA relationships, as needed.
- Bachelor and/or Masters degree (healthcare and/or scientific-related discipline is highly desirable).
- Minimum 6-10 years of GCP and/or GVP quality assurance experience in a pharmaceuticals or biotechnology industry.
- Demonstrated track record of both GCP and GVP auditing experience
- Good understanding of end to end clinical development process, including postmarketing studies (e.g., PASS).
- Thorough understanding of regulatory requirements governing GCP and GVP, including EU regulations.
- Good knowledge of computer system validation in association with GVP/GCP audits.
- Experience with hosting or participating in regulatory inspections (e.g., FDA, EMA, MHRA).
- Experience with risk-based quality system approaches.
- Experience writing and reviewing SOPs which support clinical trials and/or PV activities.
- Excellent interpersonal, verbal, and written communication skills.
- Team player and flexible.
- Strong organizational and time management skills.
- Demonstrates attention to detail and high quality while meeting deadlines and commitments.
- Ability to travel 40-50% (domestic and international), sometimes on short notice.
Please visit our website, www.ionispharma.com for more information about Ionis and to apply for this position; reference requisition # IONIS003202
Ionis offers an excellent benefits package! Follow this link for more details: Ionis Benefits
The United States pay scale for this position is $87,602 USD to $185,955 USD
NO PHONE CALLS PLEASE. PRINCIPALS ONLY.
Ionis Pharmaceuticals, Inc. and all its subsidiaries are proud to be EEO employers.ID:uDnQdo