Manager, Senior Manager – Development Quality Assurance

🕒 September 18

🇺🇸 United States – Remote

💵 $77.2k - $130.6k / year

⏰ Full Time

🟠 Senior

🔧 QA Engineer (Quality Assurance)

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Ionis Pharmaceuticals, Inc.

WebsiteLinkedInAll Job Openings

501 - 1000 employees

Founded 1989

🏥 Healthcare

🧬 Biotechnology

💊 Pharmaceuticals

Healthcare • Biotechnology • Pharmaceuticals

Ionis Pharmaceuticals, Inc. is a biopharmaceutical company focused on discovering and developing RNA- and DNA-targeted medicines to treat serious diseases. The company leverages oligonucleotide chemistry and genetic insights to advance a pipeline of therapeutics across neurology, cardiometabolic disorders, and other high-need areas, conducting clinical trials and commercial collaborations to deliver medicines to patients. Ionis emphasizes scientific innovation, patient advocacy, and corporate responsibility in its efforts to translate genetic science into transformative therapies.

📋 Description

• Provide quality oversight and support for creation, revision, review, approval, periodic review, and retirement of Development controlled documents within Veeva Quality • Perform document quality reviews for consistency, clarity, regulatory compliance, and adherence to Ionis standards • Guide Development stakeholders on controlled document requirements, workflows, templates, and lifecycle activities • Support management and continuous improvement of Development QMS processes and associated tools • Author or revise Development QA procedures, templates, and tools • Support deviations, CAPAs, and effectiveness checks • Monitor, analyze, and report Development QMS metrics and trends • Prepare periodic QMS reports and materials for biannual quality management review meetings • Identify recurring trends, systemic risks, and opportunities for process and QMS improvement • Partner with stakeholders and leadership to resolve quality issues • Conduct CSR, TMF, and other GCP-related audits as assigned • Review audit reports, responses, corrective actions, and CAPAs • Support planning, preparation, conduct, and follow-up of global Health Authority inspections • Remain current on regulations, regulatory intelligence, and potential impact • Use approved company technology, including AI-enabled and digital tools, with appropriate human oversight

🎯 Requirements

• Bachelor’s degree with a minimum of 5 years of GCP quality assurance experience, or an equivalent combination of education and experience • Healthcare or scientific-related discipline preferred • Strong working knowledge of the clinical development process, ICH Guidelines, applicable global GCP regulatory requirements, and quality management principles • Knowledge of other GxP areas, such as GVP, a plus • Experience writing and reviewing SOPs supporting clinical research highly desirable • Experience conducting or supporting GCP audits, document audits, and TMF audits • Experience with electronic QMS platforms; Veeva Quality preferred • Experience managing controlled document lifecycle activities and performing document quality reviews • Demonstrated attention to detail and commitment to high-quality deliverables while meeting deadlines and commitments • Effective verbal and written communication skills • Effective interpersonal skills and ability to work collaboratively as a team player • Organizational and time management skills • Ability to collaborate effectively with cross-functional teams across geographies • Strong customer service orientation • Ability to manage multiple projects in a dynamic environment and meet accelerated timelines • Ability to travel as business needs require, including on short notice when needed

🏖️ Benefits

• Excellent benefits package • Onsite, hybrid, and remote work environments • Reasonable accommodation for applicants with disabilities

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