- 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.
-
Director of Quality Assurance
3 weeks ago
UniSea Redmond, United StatesPosition Description: · The Quality Assurance Director is responsible for overseeing Quality Assurance programs for both Dutch Harbor, Alaska and Redmond, WA production facilities and ensuring compliance with all Federal and State agencies and required customer audits. · Essentia ...
-
Quality Assurance Engineer
3 days ago
Lindsay's Smoothies Kirkland, United States Full timeJob ID: · Location: Santa Clara, USA · Job Title: Quality Assurance Engineer I · Reports to: Quality Assurance Manager, Engineering Director · Job Description and Responsibilities: · Read and comprehend specifications and designs · Create quality test plans and test cases · Pe ...
-
Sr Manager, Quality Assurance
1 week ago
Nintendo Redmond, United StatesDESCRIPTION OF DUTIES: Works cross-functionally with leadership to ensure alignment of the company's strategy and objectives with quality system policies and practices. · Leads the ongoing development and implementation of Nintendo's Quality Program by working cross functionally ...
-
Quality Assurance Administrator
3 weeks ago
Laurentide Controls Kirkland, United StatesQUALITY ASSURANCE ADMINISTRATOR (TEMPORARY 14 MONTHS) · Come join the largest supplier of automation and reliability solutions in our region. Discover what we can offer you and be the voice that cultivates innovative ideas To Help Industry Thrive in Eastern Canada. · SOUNDS EXCIT ...
-
Sr. Director Quality Assurance
3 weeks ago
SystImmune Redmond, United StatesThis position requires a hybrid working model, with expectations of being in office 2-3 days a week at either the headquarters of Redmond, WA or an office in central New Jersey, which location is being determined. · Company Overview: · SystImmune Inc. is a dynamic clinical-stage ...
-
Sr. Director Quality Assurance
3 weeks ago
SystImmune Redmond, United StatesThis position requires a hybrid working model, with expectations of being in office 2-3 days a week at either the headquarters of Redmond, WA or an office in central New Jersey, which location is being determined. · Company Overview: · SystImmune Inc. is a dynamic clinical-stage ...
-
Quality Assurance Tech II
2 weeks ago
TalentBurst, Inc. Redmond, United States ContractQuality Assurance Engineer · Location: Redmond, WA · Estimated Start Date: 05/06/24 · Duration: 6 months High chance of extension. · Number and Type of Interviews: 2, 45 minute Interviews [1 with HM, 1 with team members] · On-site preferred but open to hybrid/remote as well. · ...
-
Sr Manager, Quality Assurance
3 weeks ago
Nintendo Redmond, United States· Nintendo of America Inc. · The worldwide pioneer in the creation of interactive entertainment, Nintendo Co., Ltd., of Kyoto, Japan, manufactures and markets hardware and software for its Nintendo Switch system and the Nintendo 3DS family of portable systems. Since 1983, when i ...
-
Eclaro Bothell, United StatesQuality Assurance Specialist · Job Number: · Be part of a company that delivers life-changing healthcare solutions. Eclaro is looking for a Quality Assurance Specialist for our client in Bothell, WA. · Eclaro's client is a leader in the Biopharmaceutical Industry, providing qua ...
-
Eclaro Bothell, United StatesQuality Assurance Specialist · Job Number: (phone number removed) · Be part of a company that delivers life-changing healthcare solutions. Eclaro is looking for a Quality Assurance Specialist for our client in Bothell, WA. · Eclaro's client is a leader in the Biopharmaceutical I ...
-
Quality Assurance Technician
1 week ago
Stryker Redmond, United StatesHere, we provide our RA/ QA team the opportunity to learn new things, as well as endless growth opportunities If you are interested in working at one of the World's Best Workplaces, Quality Assurance Technician, Quality Assurance, Technician, 1st Shift, Assurance, Manufacturing, ...
-
Pyramid Consulting Bothell, United StatesImmediate need for a talented QA. This is a 06+ Months Contract opportunity with long-term potential and is located in Bothell, WA(Onsite). Please review the job description below and contact me ASAP if you are interested. · Job ID: · Pay Range: $85 - $86/hour. Employee benefit ...
-
Quality Assurance Technician
1 week ago
Stryker Group LLC Redmond, United StatesWhy RA/QA at Stryker? · Are you interested in working for a global company where you can work across functions and on a wide-variety of projects? As a member of Stryker's RA/QA team, that is exactly what you will do Here, we provide our RA/QA team the opportunity to learn new th ...
-
Quality Assurance Specialist
1 week ago
SSi People Bothell, United StatesRole: Quality Assurance Specialist · Contract: 6 Months · Location: Bothell, WA (100% onsite) · Major duties and responsibilities: · Quality Management System performance metric preparation and reporting. Compile, contextualize, evaluate, and present Quality Systems data and metr ...
-
Quality Assurance Technician
1 week ago
Stryker Group LLC Redmond, United StatesWhy RA/QA at Stryker? · Are you interested in working for a global company where you can work across functions and on a wide-variety of projects? As a member of Stryker's RA/QA team, that is exactly what you will do Here, we provide our RA/QA team the opportunity to learn new th ...
-
Quality Assurance Specialist
5 days ago
Crox Consulting Inc Bothell, United StatesMajor duites and responsibilities: · • Quality Management System performance metric preparation and reporting. Compile, contextualize, evaluate, and present Quality Systems data and metrics. · • Investigation & CAPA Review Board Administrator. Compile slides and assemble presenta ...
-
Quality Assurance Associate
6 days ago
Integrated Resources, Inc ( IRI ) Bothell, United StatesTOP Skills: · • Bachelor's degree in life or physical sciences · • Strong analytical and communication skills. · • Computer proficiency as well as the ability to master new software programs. · • The ability to work effectively with others. · • Experience working in a GMP environ ...
-
Quality Assurance Specialist
5 days ago
System One Holdings, LLC Bothell, United StatesJob Title: Quality Assurance SpecialistLocation: Bothell, WACompensation: $75.00- $84.57Type: ContractOverviewLeading pharmaceutical company looking for an experienced Quality Assurance Specialist. Ideal candidates should have a minimum of 3 years of experience in pharmaceutical ...
-
Quality Assurance Specialist
2 weeks ago
Primary Talent Partners Bothell, United StatesPrimary Talent Partners has a 6-month contract opening for a Quality Assurance Specialist with one of our pharmaceutical clients in Bothell, WA. · Job Title: Quality Assurance Specialist · Pay: $ $84.50/hour · Location: 100% Onsite in Bothell, WA - local candidates only · Term: 6 ...
-
Quality Assurance Specialist
2 weeks ago
Sunrise Systems Inc Bothell, United StatesJob Description: · Quality Systems support within Quality Operations. Ensure that Client Co. products manufactured at external contract manufacturers are manufactured, tested and released according to established Client specifications and the principles of Client directives. · ...
Director/Sr. Director of Clinical Quality Assurance - Redmond, United States - SystImmune Inc.
Description
Director/Sr. Director of Clinical Quality AssuranceRedmond, WA
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:
SystImmune is a stable, well-funded biotech company with a bright future. We offer an opportunity for you to learn and grow while making significant contributions to the company's success. 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.
SystImmune is an Equal Opportunity Employer. Interested applicants should send their CV and cover letter to[email protected]
