Kelly Government Solutions is seeking a talented Manager of Quality Assurance with expertise in CMC and early-stage drug development (pre-IND and early clinical) compliance for a direct hire opportunity. This role will be responsible for overseeing and managing all aspects of Quality Assurance operations, ensuring that all applicable regulations are followed and that the highest quality standards are maintained throughout the drug development process. This includes developing and implementing quality systems, conducting gap analyses and remediation activities, and collaborating effectively with cross-functional teams, including manufacturing, QC, CMC regulatory, and Contract Research Organizations.
The ideal candidate will have a solid understanding of relevant regulatory agency guidance, including ICH and FDA regulations, and will be adept at working both independently and collaboratively. They will also possess strong communication and interpersonal skills, as well as the ability to lead and motivate a team.
Key Responsibilities:
Oversee overall QA operations and ensure regulatory compliance.
Develop and implement quality systems.
Conduct gap analyses and remediation.
Collaborate with manufacturing, QC, CMC regulatory, and CROs.
Qualifications:
Minimum 5 years of QA experience in a pharmaceutical setting.
Expertise in CMC and early-stage compliance.
Strong knowledge of ICH and FDA regulations.
Excellent communication and collaboration skills.
Benefits:
401(k)
401(k) matching
Flexible schedule
Paid time off
Health and Dental plans
If you are a highly motivated and experienced Quality Assurance professional with a passion for ensuring product quality and compliance, we encourage you to apply for this exciting opportunity. Please send your resume to Kristi.boggs@kellyservices.com
As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here (https://www.mykelly.com/help-support-working-with-kelly-us/#Benefits) for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.
Why Kelly ® Government Solutions?
Looking to connect with premier government agencies or the top 25 federal government contractors? Kelly Government Solutions partners with these organizations to create expert talent solutions that solve the world's most critical challenges. We offer a variety of full-time, project (SOW), seasonal, and surge support opportunities in science, engineering, technology, professional, and administrative support roles. Our experts will connect you to the opportunity that fits your schedule and interests and handle the details of transferring and processing all levels of security clearances. It's just another way we make the job search work for you.
About Kelly
Work changes everything. And at Kelly, we're obsessed with where it can take you. To us, it's about more than simply accepting your next job opportunity. It's the fuel that powers every next step of your life. It's the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life-just ask the 300,000 people we employ each year.
Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly's Human Resource Knowledge Center.
Kelly complies with the requirements of California's state and local Fair Chance laws. A conviction does not automatically bar individuals from employment. Kelly participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.
Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly's Human Resource Knowledge Center. Kelly complies with the requirements of California's state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.
