Executive Director, GMP Quality

Core Responsibilities

Provide strategic leadership and direction for GMP Quality activities supporting the Carlsbad campus, Faraday facility, and Ionis development lifecycle products manufactured internally or outsourced to CMOs.

Lead the establishment and enhancement of GMP Quality processes for clinical supply, drug substance and drug product manufacturing, testing, and release activities in accordance with applicable GMP regulations and guidelines (e.g. EU, FDA, HC, ICH, MHLW, TGA, etc.).

Provide senior QA expertise and strategic guidance on quality issues, including manufacturing deviations, investigations, CAPAs, change controls, OOS/OOT results, and other GMP matters.

Lead and influence relationships with CMOs, business partners, Technical Operations, Manufacturing, QC, Regulatory, and Ionis leadership to support risk management, issue resolution, continuous improvement, and a culture committed to quality excellence.

Lead audit and inspection readiness for the Carlsbad campus, Faraday facility, and external service providers; lead the development of responses to health authority observations; and serve as the lead QA representative during health authority inspections of the Faraday campus.

Lead the development and enhancement of Quality policies, programs, procedures, and training to support Ionis business objectives and promote consistent GMP Quality standards.

Requirements

• Minimum of 20 years of QA, GMP Quality, or compliance experience, with 10+ years of senior leadership experience leading and developing a Quality organization in a pharmaceutical or biotechnology manufacturing setting.
• Demonstrated success providing strategic direction, developing Quality processes and procedures, and establishing a culture committed to Quality excellence.
• A degree in a relevant scientific, engineering, pharmacy, or related discipline is preferred.
• Significant experience with regulatory inspections, audits, investigations, CAPA, change control, risk management, and applicable USA/global GMP requirements.
• Experience with biologics and drug substance and/or drug product manufacturing is required; experience with aseptic products, combination products, or other complex pharmaceutical operations is preferred.
• Proven record of strong senior-level people, program, communication, stakeholder-management, influencing, and strategic leadership skills, with the judgment to establish priorities, manage risk, and escalate quality issues appropriately.
• Proven ability to lead cross-functional initiatives, coach and mentor colleagues, represent Quality with internal and external stakeholders, and drive compliant, sustainable improvements while maintaining alignment with established functional accountabilities.

Qualifications

• Demonstrated ability to lead cross-functional initiatives;
• Coach and mentor colleagues;
• Represent Quality with internal and external stakeholders;
• Drive compliant, sustainable improvements aligned with established functional accountabilities.

Benefits

Please visit our website, http://www.ionis.com for more information about Ionis and to apply for this position; reference requisition #IONIS004102.

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