Deciphera Pharmaceuticals
201 - 500 employees
Founded 2016
🧬 Biotechnology
đź’Š Pharmaceuticals
Biotechnology • Pharmaceuticals
Deciphera Pharmaceuticals is a biotechnology company dedicated to defeating cancer by developing innovative kinase inhibitors to improve patient outcomes. The company focuses on designing switch-control kinase inhibitors to address mechanisms of tumor and drug resistance, aiming to enhance treatment responses for patients with cancer. Deciphera has a diverse pipeline of drug candidates, including ripretinib and vimseltinib, and is committed to making a significant impact on the lives of cancer patients. As of June 2024, Deciphera is a wholly-owned subsidiary of ONO Pharma and continues to work on improving human health through its scientific innovations and patient-centric approach.
Senior Manager, Clinical Quality Assurance
đź•’ April 29
🍂 Massachusetts – Remote
đź’µ $138k - $190k / year
⏰ Full Time
đźź Senior
🔧 QA Engineer (Quality Assurance)
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Deciphera Pharmaceuticals
201 - 500 employees
Founded 2016
🧬 Biotechnology
đź’Š Pharmaceuticals
Biotechnology • Pharmaceuticals
Deciphera Pharmaceuticals is a biotechnology company dedicated to defeating cancer by developing innovative kinase inhibitors to improve patient outcomes. The company focuses on designing switch-control kinase inhibitors to address mechanisms of tumor and drug resistance, aiming to enhance treatment responses for patients with cancer. Deciphera has a diverse pipeline of drug candidates, including ripretinib and vimseltinib, and is committed to making a significant impact on the lives of cancer patients. As of June 2024, Deciphera is a wholly-owned subsidiary of ONO Pharma and continues to work on improving human health through its scientific innovations and patient-centric approach.
đź“‹ Description
• Draft, review or revise Clinical QA SOPs to assess consistency and compliance with regulatory requirements/internal standards. • Attend cross-functional team meetings and provide guidance to clinical operations staff based on interpretation of current regulations to ensure best practices including risk-based management. • Work closely with Clinical Operations to ensure/coordinate appropriate and complete resolution of findings/non-compliant issues, quality investigations, etc. in a timely manner, including approval of corrective action and preventative action (CAPA) plans, as necessary. • Provide Quality Control (QC) review of clinical protocols, amendments, Informed Consent Forms, Clinical Study Reports and other clinical trial related documents. • Assist and advise with training QA and clinical staff as necessary for GCP. • Identify potential systemic gaps and coordinate with the appropriate stakeholder to ensure timely remediation. • As appropriate, escalate issues of critical non-compliance and/or lack of urgency in remediation to senior management via the Quality Board. • Perform program specific root cause analysis of compliance issues and provide the appropriate metrics for tracking and trending for the overall QA reporting requirements to functional and senior management. • Conduct and/or assist in internal audits (systems, processes, vendors, computer system validation). • Interact with contract auditors in the scheduling process, kick-off meetings with auditors and internal groups, assist in the drafting of audit plans, confirmation letters and agendas, etc. • Identify the need for, conduct and/or assist in external audits (includes, but is not limited to, investigator sites, central IRBs, CROs and clinical labs). • Oversee the audit response process for the Investigator Site and Contract Research Organization (CRO) audits/inspections and ensure acceptability of actions to address findings through the CAPA process. • Assist with inspection readiness, and regulatory inspections as needed. • Other duties and responsibilities as assigned.
🎯 Requirements
• 8+ years of direct GCP pharmaceutical/biotechnology experience with Bachelors degree or equivalent. • Solid understanding and application of GCP, GLP and ICH requirements, especially ICH E6R3. • A well organized, self-motivated and independent work style with the ability to initiate and follow through on assignments. • Excellent interpersonal skills with knowledge of basic negotiation, influencing and conflict management to assure effective interactions within and across departments. • The ability to simultaneously handle multiple project issues while dealing with time demands, incomplete information, or unexpected events. • Broad experience in product development, clinical operations, regulatory compliance and GCP auditing. • Willingness to travel up to 25% both domestic and international.
🏖️ Benefits
• Competitive salary and annual bonus. • Comprehensive benefits package including medical, dental, vision insurance, 401(k) retirement plan with company match, and more. • Generous parental leave and family planning benefits. • Outstanding culture and opportunities for personal and professional growth.
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