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1+ months

AssociateDirector, Clinical QA

Kelly Services
Seattle, WA 98194
**Associate Director, Clinical QA**


Commercial-stage biopharmaceutical company committed to discovering, developing and commercializing small-molecule and protein therapeutics for large-market and orphan indications targeting inflammation, complement-mediated diseases, disorders of the central nervous system and immune-related diseases, including cancers.


**_What are_** **_your job responsibilities?_**


In this role you will provide support and proactive strategic planning for QA oversight of clinical development activities. You will be responsible for domestic and international clinical and vendor audits and will work with internal stakeholders, participate cross functionally, and use your creative problem-solving skills on complex compliance issues. Youll conduct audits, facilitate and support regulatory authority GCP inspections, both at clinical sites. Additionally, youll develop and/or review CQA SOPs and associated documents.


Your role will include:


+ Participating in the evaluation and qualification of CROs and other service providers

+ Conducting external and internal audits to assess compliance with GCP requirements, investigational plans and company standards for clinical trial-related activities

+ Communicating audit findings to audit stakeholders ensuring understanding as well as collaborating with auditees to ensure appropriate implementation of Corrective and Preventive Action Plans (CAPAs), addressing root causes

+ Tracking, reviewing, approving, and assessing the adequacy of CAPAs

+ Maintaining databases for audit observations and CAPAs

+ Sharing responsibility with the team for the development of training materials and conducting training

+ Assisting with the preparation, coordination, and management of regulatory agency inspections

+ Reviewing and updating CQA SOPs, identifying the need for new CQA SOPs, and developing new CQA SOPs, as needed


**_What experience_** **_and education do you need?_**


Youll need a Bachelors degree in a life science or a related field with 8+ years of relevant pharmaceutical industry experience in GCP/clinical quality assurance with a minimum of 5 years of Good Clinical Practices (GCP) auditing experience. Global Clinical QA experience is desired.


**_What skills does our ideal candidate have?_**


As our ideal candidate, your areas of expertise include Phase 1 Phase 4 clinical trials, clinical investigator site audits, vendor audits, and ICH/GCP knowledge. In addition, youll possess:


+ An in-depth knowledge and clear understanding of GCP regulations and industry standards

+ Excellent organizational, planning and prioritizing skills

+ Exceptional communication skills, both written and verbal

+ Effective cross-functional and intra-functional collaboration skills

+ Demonstrated success in building and maintaining relationships as well as influencing internal and external colleagues and collaborators

+ The ability to present in a professional manner and write routine reports and correspondence

+ Strong computer skills in applications used in general office settings such as word processing, spreadsheet, presentation, data base management, and internet search engine applications

+ Strong decision-making, situation analysis, and creative problem-solving skills

+ A proven attention to detail and an orientation for meticulous work


**_Other things youll need to know:_**


+ This role requires 20% to 30% travel, both domestic and international


**\#TJP2021_SPEC**


**Why Kelly** **** **?**


Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.


**About Kelly** ****


At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm)
Posted: 2021-03-05 Expires: 2021-04-26

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AssociateDirector, Clinical QA

Kelly Services
Seattle, WA 98194

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