Assistant Director/Associate Director, GMP Quality - Drug Substance (Clinical &
Ionis, Carlsbad, California, United States, 92002
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!
Assistant Director/Associate Director, GMP Quality- Drug Substance (Clinical & Commercial)
Job Summary:
Ionis is seeking an experienced Assistant Director/Associate Director, GMP Quality – Drug Substance to lead and oversee Quality Assurance activities supporting both clinical and commercial Drug Substance (DS) manufacturing and testing. This role provides strategic quality leadership across Ionis’ Drug Substance portfolio, spanning early clinical development through commercial manufacturing.
The successful candidate will serve as a key Quality partner to Technical Operations and external manufacturing and testing organizations, with direct influence on inspection readiness, product supply, and lifecycle execution. This role combines strategic leadership, operational oversight, and hands-on QA expertise across internal operations and external partners and offers high visibility and autonomy to shape quality strategy, support critical manufacturing activities, and drive continuous improvement across the organization.
Strategic and Leadership Responsibilities:
Lead and manage GMP Quality Assurance activities supporting internal and external Drug Substance and Intermediate manufacturing, testing, and release. May manage, mentor, and develop QA staff and/or provide functional leadership to matrixed teams, depending on organizational needs. Provide QA oversight across clinical and commercial programs, ensuring phase-appropriate compliance and inspection readiness. Drive continuous improvement initiatives to enhance compliance, efficiency, and product quality. Collaborate cross-functionally with Technical Operations, CMC, Regulatory, Clinical, Supply Chain, and IT teams. Communicate quality- or supply-impacting issues clearly to internal and external stakeholders. Operational Oversight:
Oversee and execute core Quality Management System (QMS) processes, including batch record review, deviations, investigations, CAPAs, change control, OOS/OOT management, risk management, validation, and training compliance. Review and approve technical and quality documentation, including validation reports, stability data, and APQR/QMR inputs. Utilize enterprise quality systems, including SAP and Veeva, to support compliant and efficient quality operations. Serve as the primary QA interface for contract manufacturing and testing organizations (CMOs), including review and approval of manufacturing documentation, analytical data, deviations, changes, and validation packages. Participate in real-time QA decision-making during critical manufacturing operations. Support and lead regulatory inspections, partner audits, and Qualified Person (QP) interactions. General Responsibilities:
Support new quality initiatives and cross-functional projects Apply strong cGMP knowledge in daily activities Perform additional duties as assigned Education & Experience
Bachelor’s degree in Chemistry, Biological Sciences, Engineering, or a related discipline (advanced degree preferred). 10–12+ years of pharmaceutical industry experience, including 7–8+ years in Quality Assurance within a cGMP environment. Demonstrated experience supporting Drug Substance manufacturing across both clinical and commercial stages. Technical & Professional Skills
Strong knowledge of global cGMP regulations (FDA, EMA, ICH, etc.). Experience with SAP and Veeva systems is highly desired. Strong analytical, technical, and critical-thinking skills with experience in manufacturing is preferred. Excellent written and verbal communication skills. Ability to manage multiple priorities and adapt to changing business needs.
Please visit our website, http://www.ionis.com for more information about Ionis and to apply for this position; reference requisition # IONIS003877
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: $102,000 to $148,000 / $139,000 to $182,000
NO PHONE CALLS PLEASE. PRINCIPALS ONLY.
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.
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!
Assistant Director/Associate Director, GMP Quality- Drug Substance (Clinical & Commercial)
Job Summary:
Ionis is seeking an experienced Assistant Director/Associate Director, GMP Quality – Drug Substance to lead and oversee Quality Assurance activities supporting both clinical and commercial Drug Substance (DS) manufacturing and testing. This role provides strategic quality leadership across Ionis’ Drug Substance portfolio, spanning early clinical development through commercial manufacturing.
The successful candidate will serve as a key Quality partner to Technical Operations and external manufacturing and testing organizations, with direct influence on inspection readiness, product supply, and lifecycle execution. This role combines strategic leadership, operational oversight, and hands-on QA expertise across internal operations and external partners and offers high visibility and autonomy to shape quality strategy, support critical manufacturing activities, and drive continuous improvement across the organization.
Strategic and Leadership Responsibilities:
Lead and manage GMP Quality Assurance activities supporting internal and external Drug Substance and Intermediate manufacturing, testing, and release. May manage, mentor, and develop QA staff and/or provide functional leadership to matrixed teams, depending on organizational needs. Provide QA oversight across clinical and commercial programs, ensuring phase-appropriate compliance and inspection readiness. Drive continuous improvement initiatives to enhance compliance, efficiency, and product quality. Collaborate cross-functionally with Technical Operations, CMC, Regulatory, Clinical, Supply Chain, and IT teams. Communicate quality- or supply-impacting issues clearly to internal and external stakeholders. Operational Oversight:
Oversee and execute core Quality Management System (QMS) processes, including batch record review, deviations, investigations, CAPAs, change control, OOS/OOT management, risk management, validation, and training compliance. Review and approve technical and quality documentation, including validation reports, stability data, and APQR/QMR inputs. Utilize enterprise quality systems, including SAP and Veeva, to support compliant and efficient quality operations. Serve as the primary QA interface for contract manufacturing and testing organizations (CMOs), including review and approval of manufacturing documentation, analytical data, deviations, changes, and validation packages. Participate in real-time QA decision-making during critical manufacturing operations. Support and lead regulatory inspections, partner audits, and Qualified Person (QP) interactions. General Responsibilities:
Support new quality initiatives and cross-functional projects Apply strong cGMP knowledge in daily activities Perform additional duties as assigned Education & Experience
Bachelor’s degree in Chemistry, Biological Sciences, Engineering, or a related discipline (advanced degree preferred). 10–12+ years of pharmaceutical industry experience, including 7–8+ years in Quality Assurance within a cGMP environment. Demonstrated experience supporting Drug Substance manufacturing across both clinical and commercial stages. Technical & Professional Skills
Strong knowledge of global cGMP regulations (FDA, EMA, ICH, etc.). Experience with SAP and Veeva systems is highly desired. Strong analytical, technical, and critical-thinking skills with experience in manufacturing is preferred. Excellent written and verbal communication skills. Ability to manage multiple priorities and adapt to changing business needs.
Please visit our website, http://www.ionis.com for more information about Ionis and to apply for this position; reference requisition # IONIS003877
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: $102,000 to $148,000 / $139,000 to $182,000
NO PHONE CALLS PLEASE. PRINCIPALS ONLY.
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.