MANAGER/ SENIOR MANAGER, GMP QUALITY - DRUG SUBSTANCESUMMARY:Ionis is seeking an experienced Manager/ Senior Manager, GMP Quality - Drug Substance to provide Quality Assurance activities supporting both clinical and commercial Drug Substance (DS) manufacturing and testing. This role provides strategic leadership, operational oversight, and hands-on QA expertise across internal operations and external manufacturing partners.
RESPONSIBILITIES: - Lead and manage GMP Quality Assurance activities supporting internal and external Drug Substance and Intermediate manufacturing, testing, and release.
- Senior Manager-level candidates are expected to demonstrate broader strategic leadership, lead complex cross-functional quality initiatives, influence quality systems and operational strategy, and independently manage regulatory inspection activities and high-risk quality decision
- Provide QA oversight across clinical and commercial programs, ensuring phase-appropriate compliance and inspection readiness.
- 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.
- Serve as the QA interface for contract manufacturing and testing organizations (CMOs), including review and approval of manufacturing documentation, analytical data, deviations, changes, and validation packages.
- Provide real-time QA support and risk-based decision-making during critical manufacturing operations
- Support and lead regulatory inspections, partner audits, and Qualified Person (QP) interactions.
- 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.
- 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.
- Drive new quality initiatives and cross-functional projects.
- Apply strong cGMP knowledge in daily activities.
- Perform additional duties as assigned.
REQUIREMENTS:- Bachelor's degree in Chemistry, Biological Sciences, Engineering, or a related discipline
- At least 5 years of pharmaceutical industry experience, including Quality Assurance within a cGMP environment
- Demonstrated experience supporting Drug Substance manufacturing across both clinical; limited commercial experience is a plus but not required.
- Experience working with CMOs/CDMOs, including oversight of manufacturing, testing, and release activities
- Working 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.
- 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 #IONIS004028
Ionis offers an excellent benefits package! Follow this link for more details:
Ionis BenefitsFull Benefits Link: https://ionis.com/careers#:~:text=Highly%20competitive%20benefits
The pay scale for this position is $70,844 to $126,585
The pay scale for the Manager position is $70,844 to $102,371
The pay scale for the Senior Manager position is $87,530 to $126,585
NO PHONE CALLS PLEASE. PRINCIPALS ONLY.
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