ASSOCIATE DIRECTOR, DEVELOPMENT QUALITY ASSURANCE

SUMMARY:

We are seeking a highly motivated individual to join as an Associate Director, Development Quality Assurance. This position is responsible for leadership, planning, conduct, and reporting of GCP audits to ensure that clinical tasks are conducted in compliance with applicable international regulations, guidelines, and Ionis standards. This role also has responsibility for preparation, management, and follow-up of global Health Authority (HA) GCP inspections, and provision of quality oversight and consultation at the clinical trial or program team level in support of proactive quality management. This individual actively leverages audit / inspection outcomes / trends to affect improvement in clinical trial quality and compliance with Ionis and global regulatory requirements. Responsibilities also include leading and/or contributing to identification, development, implementation, management, and enhancement of Development QA operational processes, systems, tools, and best practices.

RESPONSIBILITIES:

Audit Planning, Conduct, Reporting, and Follow-up:

• Perform QA risk assessments and contribute to the maintenance of a comprehensive, risk-based GCP/GLP/GVP audit program.
• Lead, conduct, and coordinate internal and external GCP-related audits, both domestic and international, of service providers, investigators, internal processes, and computerized systems supporting GxP-regulated activities.
• Lead or perform for-cause audits, high-profile audits, special projects, and investigations to evaluate noncompliance, identify root causes, and report results to leadership.
• Prepare and/or review timely, well-written audit reports, and communicate findings to auditees, cross-functional representatives, and management.
• Assess and review audit responses to ensure CAPA plans adequately address findings and root causes, including effectiveness checks where appropriate, and maintain, track, and follow up on CAPAs through completion.

Health Authority Inspection Planning, Preparation, Management, and Follow-up:

• Lead end-to-end preparation for and management of global Health Authority GCP inspections.
• Oversee inspection readiness activities, including creation and maintenance of pre-inspection materials, training for designated SMEs, conducting pre-inspection visits at investigator sites and service providers and coordination of preparation meetings for functional area heads and appropriate staff.
• Lead and/or contribute to the assessment of Health Authority inspection reports and results, including associated risks and recommendations, for communication to relevant leadership.
• Oversee inspection follow-up activities, including preparation of final response documents, cross-functional coordination of required actions, and tracking and maintenance of Development QA-managed Health Authority inspection data.

Clinical Program/Trial Quality Support, Consultancy, and Other:

• Mentor, support, and/or manage the activities of internal and external Development QA personnel.
• Maintain ongoing awareness of program- and trial-level quality, safety, and efficacy issues, and provide quality oversight and consultation to ensure GCP compliance and continuous inspection readiness throughout the trial.
• Support RBQM and risk management activities (e.g., RACT), including risk identification and mitigation for potential or identified quality issues.
• Appropriately escalate quality and compliance issues to relevant leadership.
• Independently manage procedural deviations, CAPAs, effectiveness checks, and potential serious breach investigations, with leadership support as needed.
• Support the risk-based service provider QA oversight strategy through periodic risk assessments and, within the Ionis governance framework, contribute to and/or lead QA-to-QA relationships.
• Leverage audit and inspection trends, metrics, and other relevant data sources to support Management Review, inform data-driven audit planning, and drive continuous improvement in clinical trial quality and compliance through stakeholder education and consultation.
• Assist in the review of GCP- and systems-related SOPs to assess adherence to applicable regulatory standards and corporate objectives.
• Define, implement, and/or lead GCP QA and/or company-wide or cross-functional annual goals and initiatives, as assigned.
• Coordinate the development, maintenance, and delivery of GCP training programs.
• Remain current on new and revised regulations and other regulatory intelligence, and assess potential impact.
• Use approved company technology, including AI-enabled and digital tools where appropriate, to support responsibilities efficiently, while ensuring that all outputs are critically reviewed, verified, and finalized through appropriate human oversight consistent with regulatory and company requirements.

REQUIREMENTS:

• A bachelor's degree with a minimum of 12 years of GCP quality assurance experience, a master's degree with a minimum of 8 years of relevant experience, a PhD with a minimum of 5 years of relevant experience, or an equivalent combination of education and experience is required with a healthcare/scientific-related discipline is highly desirable.
• Thorough understanding of the clinical development process, including ICH Guidelines and GCP regulatory requirements.
• Good knowledge of Computer System Validation as it relates to GCP audits is preferred.
• Experience managing or participating in Health Authority inspections (e.g., FDA, EMA, MHRA), including mock inspection readiness planning and execution.
• GLP and/or Pharmacovigilance auditing experience is a plus.
• Experience with risk management or risk-based approaches to auditing and monitoring is highly desirable.
• Experience writing and reviewing SOPs that support clinical trials is a plus.
• Effective verbal and written communication skills.
• Strong interpersonal skills, with the ability to work collaboratively as a team player while remaining flexible without compromising quality.
• Strong organizational and time management skills.
• Demonstrated attention to detail and commitment to high-quality deliverables while meeting deadlines and commitments.
• Ability to collaborate effectively with cross-functional teams across geographies to achieve shared objectives while encouraging the same in others.
• Ability to manage multiple projects in a dynamic environment and meet accelerated timelines.
• Ability to travel 30-40%, both domestically and internationally, including on short notice.

Please visit our website, http://www.ionis.com for more information about Ionis and to apply for this position; reference requisition #IONIS004059

Ionis offers an excellent benefits package! Follow this link for more details: Ionis Benefits

Full Benefits Link: https://ionis.com/careers#:~:text=Highly%20competitive%20benefits

The pay scale for this position is $154,500 to $196,873

NO PHONE CALLS PLEASE. PRINCIPALS ONLY.