Manager – Development Quality Assurance

🔥 5 minutes ago

🇺🇸 United States – Remote

💵 $77.2k - $130.6k / year

⏰ Full Time

🟠 Senior

🔧 QA Engineer (Quality Assurance)

👻 Ghost score 0%

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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 the creation, revision, review, approval, periodic review, and retirement of Development controlled documents within Veeva Quality • Perform document quality reviews to promote consistency, clarity, compliance with applicable requirements, and adherence to Ionis controlled document standards • Provide guidance and support to Development stakeholders regarding controlled document requirements, workflows, templates, and lifecycle activities • Support management and continuous improvement of Development QMS processes and associated templates/tools • Author/revise Development QA procedures, templates, and tools as assigned • Support Development stakeholders with deviations, CAPAs, effectiveness checks, and other QMS activities • Monitor, analyze, and report Development QMS metrics and trends • Prepare periodic QMS reports, metrics, analyses, and supporting materials for biannual QMR meetings • Identify recurring trends, potential systemic risks, and opportunities for process and QMS improvement • Partner with Development stakeholders and leadership to support timely and effective resolution of identified quality issues • Conduct CSR and/or TMF audits and other GCP-related audits as assigned • Review audit reports and related responses, corrective actions, and CAPAs • Support planning, preparation, conduct, and follow-up of global Health Authority inspections • Remain current on new and revised regulations and regulatory intelligence • Use approved company technology, including AI-enabled and digital tools where appropriate, 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 is 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 (e.g., GVP) a plus • Experience writing and reviewing SOPs that support clinical research is highly desirable • Experience conducting or supporting GCP audits, document, and TMF audits • Experience with electronic QMS platforms; experience with Veeva Quality is 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, with the ability to work collaboratively as a team player while remaining flexible without compromising quality • Organizational and time management skills • Ability to collaborate effectively with cross-functional teams across geographies to achieve shared objectives • 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 • Highly competitive benefits