Executive Director, GMP Quality

Ionis Brand; Carlsbad (CA); On-site; USD 221,000 - 289,000; Full time

Job summary

Ionis Pharmaceuticals, Inc. in Carlsbad, CA, leads GMP Quality for the campus and affiliated sites, guiding QA leadership across development and manufacturing stages. The role collaborates with CMOs, operations, and regulatory teams to ensure compliance and readiness for inspections.

The Executive Director, GMP Quality reports to the VP and shapes policies, programs, and training to sustain a culture of quality excellence while supporting Ionis' strategic goals and lead compounds.

Qualifications

• 20+ years of QA, GMP Quality, or compliance experience.
• 10+ years of senior leadership leading a Quality organization in pharma/biotech.
• Experience with regulatory inspections, audits, CAPA, change control, risk management, and USA/global GMP requirements.
• Experience with biologics and drug substance/product manufacturing.

Responsibilities

• Provide strategic leadership for GMP Quality at Carlsbad and Faraday facilities and external providers.
• Establish and enhance GMP Quality processes for clinical supply, drug substance/product manufacturing, testing and release.
• Provide senior QA guidance on deviations, investigations, CAPAs, change controls and OOS/OOT matters.
• Lead relationships with CMOs, operations, Regulatory, and leadership for risk management and improvements.
• Provide strategic Quality direction for new compounds and novel manufacturing processes.
• Lead audit readiness and responses to health authority observations for multiple sites.
• Develop and enhance Quality policies, programs, procedures, and training.

Skills

QA leadership

Regulatory inspections

Risk management

Cross-functional leadership

Stakeholder management

Quality systems

CAPA

Change control

Audit readiness

Strategic thinking

Education

Bachelor's degree in a relevant scientific/engineering/pharmacy field

Job description

Headquartered in Carlsbad, California, and with offices in Boston, Massachusetts, and Dublin, Ireland, Ionis has been at work for more than three decades discovering medical breakthroughs that have redefined life for people with serious diseases. We’re pioneers in RNA-targeted medicines, and our platform continues to revolutionize drug discovery and transform lives for patients with unmet needs. With multiple marketed medicines and a leading pipeline in neurology, cardiology and select areas of high patient needs, we continue to drive innovation in RNA therapies in addition to advancing new approaches in gene editing to provide greater value to patients and are well positioned financially to deliver on our strategic goals.

At Ionis, we pride ourselves on cultivating a challenging, motivating and rewarding environment that fosters innovation and scientific excellence. We know that our success is a direct result of the exceptional talents and dedication of our employees.

With an unprecedented opportunity to change the course of human health, we look to add diverse individuals, skill sets and perspectives to our exceptional team. We continue to invest time, money and energy into making our onsite, hybrid and remote work environments a place where solid and lasting relationships are built and where our culture and employees can thrive.

We’re building on our rich history, and we believe our greatest achievements are ahead of us. If you’re passionate about the opportunity to have meaningful impact on patients in need, we invite you to apply and join us. Experience and contribute to our unique culture while you develop and expand your career!

EXECUTIVE DIRECTOR, GMP QUALITY SUMMARY:

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.

WORK LOCATION : onsite in Carlsbad, CA 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.
• 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.

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 elevate quality issues appropriately.
• Demonstrated 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. - this is a run on, we need to shorten
• 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.

The pay scale for this position is $221,151 to $288,783

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

Equal Opportunity Employer
This employer is required to notify all applicants of their rights pursuant to federal employment laws.For further information, please review the Know Your Rights notice from the Department of Labor.