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1+ months

Senior Manager, Quality Systems

Kelly Services
Seattle, WA 98194
**Kelly Science and Clinical** is the worlds most recognized brand in science and clinical staffing with more than 100 locations in North America, Europe, and the Pacific Rim. Our scientists contribute to the research and development of the next generation of small molecule drugs, biologics and cellular therapies.


**Overview**


This position performs a wide variety of activities to ensure compliance with applicable GxP and other regulatory requirements for one of our clients, a commercial-stage biopharmaceutical company committed to discovering, developing and commercializing small-molecule and protein therapeutics for a wide variety of disorders.


**Responsibilities**


+ ??Provide support to the current Quality Systems for GxP activities

+ Ensure that the changes related to manufacturing are evaluated and implemented to meet GMP and internal standards

+ Manage the supplier/vendor qualification systems in support of GMP activities.

+ Manage internal and external Deviation/CAPA system

+ Provide QA support for validations including reviewing protocols and reports

+ support in review of specification and test methods

+ Oversee annual quality management review

+ Ensure compliance with training, doc management, plus preparation and review of Standard Operating Procedures


**Qualifications**


+ A bachelors degree in science and at least seven years of experience in pharmaceutical/ biotech Quality Assurance

+ In-depth knowledge of quality systems and how quality systems are designed and operated to satisfy regulatory requirements

+ Working knowledge and experience with GxP regulations as well as industry standards (USP, Ph. Eur., ICH, FDA, EU guidance

+ Experience in change control, deviation management, and supplier/vendor qualification

+ Knowledge of the principles and practices of computer applications including word processing, spreadsheet, database management, and presentation software and internet search engines

+ Excellent written and verbal skills required

+ Must have the ability to build and maintain positive relationships with management, peers, and direct reports

+ Must display strong analytical and problem-solving skills

+ Self-motivated and able to function effectively within team

+ Attention to detail required


\#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: 2021-05-01

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Senior Manager, Quality Systems

Kelly Services
Seattle, WA 98194

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