Executive Director, GMP Quality

Ionis•Carlsbad, CA

2d•Onsite

About The Position

The Executive Director, GMP Quality is a senior QA leadership position and the senior GMP Quality leader supporting the Carlsbad campus. The position provides strategic direction and leadership for GMP Quality activities and initiatives across the drug development lifecycle through clinical and commercial supply, including internal operations and activities managed through CMOs and other service providers. The position is accountable for ensuring effective GMP Quality oversight and for developing and enhancing QA operations in accordance with applicable cGMP requirements. The scope of the position includes drug substance and drug product manufacturing support and related GMP Quality activities at the Carlsbad campus and Faraday facility, as well as activities conducted internally by Ionis and externally through CMOs and other service providers. The position is accountable for strategic oversight of Quality relationships with Ionis business partners and serves as a key interface for domestic and international regulatory GMP inspections, audits, and partner communications as they relate to Quality. The position leads audit and inspection readiness activities and serves as the lead QA representative during health authority inspections of the Faraday campus. The Executive Director, GMP Quality reports directly to the Vice President of GMP Quality.

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.
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.
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.

Nice To Haves

A degree in a relevant scientific, engineering, pharmacy, or related discipline is preferred.
experience with aseptic products, combination products, or other complex pharmaceutical operations is preferred.

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.
Provide strategic Quality direction and oversight for Ionis' new compounds, new chemistries, and novel manufacturing processes, as applicable.
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.
Demonstrated ability to lead cross-functional initiatives; coach and mentor colleagues; represent Quality with internal and external stakeholders; and drive compliant, sustainable improvements aligned with established functional accountabilities.