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27 days old

Senior Director of QA

Kelly Services
San Diego, CA 92108
Kelly Science has a great opportunity as a **Sr. Director of QA in San Diego CA!**


You will be responsible for creating and implementing the GxP inspection readiness strategy for the Company.


**Responsibilities:**

Identify inspection readiness goals, collaborate with cross-functional leaders to champion the process as well as to identify and implement operational oversight and quality activities within clinical development in support of global inspection readiness. Lead global inspections, response strategy and development and execution of resulting CAPA plans.

Provide regulatory expertise and consultative guidance related to business initiatives and lead quality initiatives involving systems, processes, procedures, regulations, and tools intended for use in clinical trial conduct and/or regulated drug development activities. Establish and manage GxP vendor management program and establish relationships with CRO and CDMO Quality Team members for the ongoing review of quality and compliance metrics and issues. Maintain a high level of expertise in global GxP regulations and internal policies and procedures that may impact clinical development and product. Lead, develop, and motivate a team of GxP Quality professionals.

Achieve established timelines within budget.



**Requirements:**

Bachelors Degree in a scientific discipline.

15+ years of experience in the pharmaceutical industry, including 5+ years in GxP Advanced knowledge and demonstrated experience in the applicable GxP regulations, FDA Good Clinical Practices, ICH Guidelines, ISO 13485, 21 CFR Part 211 and 820, and Global Drug Development Regulations and Guidance.


Interested? Please apply now!


**You should know:** Your safety matters! Vaccination against COVID-19 may be a requirement for this job in compliance with current client and governmental policies. A Kelly recruiter will confirm and share more details with you during the interview process.


**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: 2022-06-03 Expires: 2022-07-04

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Senior Director of QA

Kelly Services
San Diego, CA 92108

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