- Drive continuous development and ensure maintenance of systems at Systimmune incompliance with GCP guidelines; including drafting and approving Clinical SOPs.
- Direct experience setting up Quality Management System.
- Manage day to day Quality responsibilities.
- Prepare audit plans and audit/risk mitigation plans.
- Perform audits on clinical investigator sites, vendors, processes, systems, and study documents to assure quality assurance compliance with regard to internal procedures as well as regulatory guidelines.
- Clearly communicate and report (verbally and in writing) audit outcomes to the organization and escalate quality issues as required.
- Provide QA expertise to the organization and quality oversight of the clinical trials, drug safety and translational activities.
- Evaluate contract partners (e.g., CROs) for the quality aspects, set up and review of procedures with external vendors.
- Ensure QA oversight of clinical trial protocols, ICFs, CSRs and other clinical trial specific documents as requested.
- Develop and maintain appropriate TMF management process.
- Perform eTMF audits.
- Manage and/or deliver yearly GCP training for staff.
- Provide advice internally and externally on GCP and quality matters.
- Proactively lead, or coordinate across, the organization in preparation, coordination, hosting, conducting, documentation and follow up for FDA, EMA or other health authority regulatory inspections.
- Maintain expert knowledge in regulatory requirements including federal, state and international regulations and applicable standards and guidance.
- Perform other duties as assigned.
- BS degree in scientific field with 10+ years' experience in biotech, pharma or CRO drug development.
- Full understanding of GCP, GLP and GMP regulations and regulatory compliance guidelines.
- Strong leadership and communication skills.
- Expert knowledge and interpretation of GCP regulations and standards.
- Direct experience with FDA, EMA, or other health authority inspections of sponsor, investigator site(s) and CRO.
- Extensive knowledge of global regulations and standards.
- Significant experience with GCP Quality Risk and CAPA Management.
- Demonstrated attention to detail, accuracy, excellent review and analytical skills in a fast-paced environment.
- Results oriented; able to determine approaches to assignments.
- Strong interpersonal skills while building/keeping/monitoring quality and compliance.
- Problem-solving skills with ability to analyze situations and/or data while considering future impact and intangible variables.
- Multitasks and ability to manage multiple global processes.
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Director/Sr. Director of Clinical Quality Assurance - Redmond, United States - SystImmune, Inc.
Description
SystImmune Inc. is a clinical-stage biopharmaceutical company located in Redmond, WA.It specializes in developing innovative cancer treatments using its established drug development platforms, focusing on bi-specific, multi-specific antibodies, and antibody-drug conjugates (ADCs).
SystImmune has several assets in various stages of clinical trials for solid tumor and hematologic indications.Alongside ongoing clinical trials, SystImmune has a strong preclinical pipeline of potential cancer therapeutics in the discovery or IND-enabling stages, representing cutting-edge biologics development.
Summary:
The Director/Sr.
Director of Clinical Quality Assurance is responsible for the quality assurance and compliance functions by managing, planning, scheduling, overseeing, and conducting GCP Quality Assurance activities.
This position will evaluate, identify, and reduce compliance risk by contributing to the development and maintenance of efficient and effective clinical quality procedures to achieve the highest level of data quality and integrity.
This position is responsible for leading auditing activities (internally and externally) to ensure quality and data integrity are maintained according to monitoring plans, GCPs and ICH guidelines.
The position ensures SystImmune is prepared for regulatory inspections and audits by the development of tools and training for functional departments.
Position Responsibilities/Essential Duties and Responsibilities:
The hiring pay range for this position is $230,000 - $280,000 per year based on skills, education, and experience relevant to the role.
SystImmune offers a comprehensive benefits package including: 100% paid employee premiums for medical/dental/vision, also STD, LTD, a 401(k) plan with a 50% company match of up to 3% and a vesting schedule of only 5 years, 15 PTO days per year, sick leave, plus 11 paid holidays and MORE.
