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Associate Director, GCP Quality Assurance & Compliance

Ionis Pharmaceuticals, Inc.

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Boston, MA
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Job Description

As posted by the hiring company

Job Overview:

For more than 30 years, Ionis Pharmaceuticals has been the leader in RNA-targeted therapy, pioneering new markets and changing standards of care with our novel antisense technology.  Scientific innovation began and continues at Ionis with the understanding that sick people depend on us.

As the first company to fully harness the power of RNA technology for human therapeutics, our platform continues to revolutionize drug discovery and transform the lives of patients with unmet needs.  Our medicines span multiple therapeutic areas, routes of administration and diverse patient populations.  Ionis innovation is driving meaningful progress for many of the most challenging health issues.

We are building upon our innovative research and drug development excellence to provide greater value to patients.  Based on the breadth and remarkable progress of our pipeline, Ionis is projecting to have a vast number of new transformational products on the market in the coming years and growing our commercial capabilities.  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 workforce, comprised of individuals from different backgrounds and with unique skill sets, into our creative and productive environment.  Join us and experience our unique culture while you develop and expand your career.

 

ASSOCIATE DIRECTOR, GCP QUALITY ASSURANCE & COMPLIANCE


SUMMARY:

We are seeking a highly motivated individual to join as an Associate Director, Quality Assurance & Compliance to ensure the quality and compliance of Ionis-sponsored clinical trials with respect to Ionis’ Standard Operating Procedures, applicable regulatory requirements (FDA, EU, ICH & country specific), and current industry standards and practices.

RESPONSIBILITIES:

Audit Planning, Conduct, Reporting, and Follow-up

  • Perform QA risk assessments & support or manage the GCP/GLP/GPV risk-based audit program on a yearly basis.
  • Perform & coordinate internal and external (both domestic and international) GCP related audits & ensure implementation of compliance systems to assure compliance with Ionis Standard Operating Procedures, FDA regulations, EMA Directives, ICH guidelines, and relevant local/regional regulatory standards.
  • 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

  • Assist management in the preparation for regulatory agency inspections and in the formalization of an “Inspection Readiness” program for Ionis.
  • 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 and Sponsor/Monitor Inspections
  • Lead/collaborate with other QA/C team members to complete inspection follow-up activities within and outside the department, as needed
  • Oversee/ensure tracking/maintenance of QA/C-managed Health Authorities Inspection data

Clinical Program/Study Quality Support, Consultancy, and Other

  • Mentor, Support, and/or manage the activities of internal & external QA/C 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 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 activities that will form the basis for continuous improvement practices and processes.
  • Assist in the review of GCP and systems related SOPs to assess their adherence to applicable regulatory standards and corporate goals.
  • Define, implement, and/or lead GCP QA and/or company/cross functional yearly goals and initiatives as assigned.
  • Coordinate development, maintenance, and delivery of GCP training programs.
  • Stay current with new or revised regulations and other regulatory intelligence.
  • Act as QA contact for vendor QA-QA relationships, as needed.

 

REQUIREMENTS:

    • Bachelor and/or Masters degree (healthcare and/or scientific-related discipline is highly desirable).
    • 10 years of GCP quality assurance experience in a pharmaceuticals or biotechnology industry.
    • GLP and/or PV auditing experience a plus
    • Good understanding of Clinical Development Process.
    • Thorough understanding of FDA GLP, GCP and ICH regulatory requirements and implementation.
    • Good knowledge of Computer System Validation in association with GLP/GCP audits.
    • Experience with hosting or participating in regulatory inspections (e.g., FDA, EMA, MHRA).
    • Risk Management or risk-based approach to auditing and monitoring experience highly desirable.
    • Experience writing and reviewing SOPs which support clinical trials a plus.
    • Effective communication (verbal and written).
    • Strong interpersonal skills, team player, and flexible without compromising quality.
    • Strong organizational and time management skills.
    • Demonstrates attention to detail and high quality while meeting deadlines and commitments.
    • Collaborates with team members across functions and geographies to get work done while encouraging others to do the same.
    • Ability to manage multiple projects in a dynamic environment and ability to meet fast-track timelines.
    • Ability to travel 40-50% (domestic and international), sometimes on short notice.

     

     


Excellent salary and benefits package offered.
For more information about Ionis and to apply for this position, please visit our website, www.ionispharma.com. Reference Requisition #IONIS002758

NO PHONE CALLS PLEASE. PRINCIPALS ONLY.

Ionis Pharmaceuticals, Inc. and all its subsidiaries are proud to be EEO employers.