Quality Assurance Manager

Job Description

Job Description

Quality Assurance Manager

Kelly® Science & Clinical is seeking a  Quality Assurance Manager for a Direct Hire  position at  leading bioanalytical organization  in  Pleasanton, CA. If you’re passionate about bringing the latest scientific discoveries to life and are ready to take the next step in your career, trust The Experts at Hiring Experts.

Salary:
$175k – $200k annually

Overview:
This client specializes in bioanalytical and CMC analytical services. In this role you will be responsible for the development, management, and continuous improvement of quality systems ensuring compliance with Good Laboratory Practice (GLP), Good Clinical Laboratory Practice (GCLP), and other applicable regulatory standards for the bioanalytical GLP lab.

Schedule:  
Monday-Friday, standard working hours

 
Responsibilities:

• Host client and regulatory inspections, including preparing and submitting responses to findings.
• Support regulatory activities across all BABM sites within the organization.
• Audit raw data, summary tables, and reports associated with GLP and GCLP protocols to ensure compliance with regulatory requirements.
• Maintain inspection readiness, including preparing and managing site-specific documentation.
• Establish and ensure compliance with GLP, GCLP, and applicable FDA and international regulatory standards.
• Develop and manage the company’s Master Schedule.
• Create, administer, and maintain QA Standard Operating Procedures (SOPs), QA files, and QA audit logs.
• Process, archive, and maintain QA department inspection reports and supporting documentation.
• Monitor and interpret regulatory requirements to ensure alignment with business processes and procedures.
• Author and review SOPs and Statistical Analysis Plans (SAPs).
• Provide GLP and GCLP training to staff.
• Recruit, develop, and mentor QA professionals, fostering a culture of growth and excellence.
• Conduct and report inspections of internal facilities and audits of external vendors to assess compliance with regulatory standards.
• Establish and administer a company Risk Register.
• Identify and address regulatory compliance issues, providing guidance to other departments.
• Deliver monthly compliance status reports to Test Site Management (TSM), highlighting issues and corrective actions.
• Represent the QA function in company meetings.

Qualifications:

• Bachelor’s degree in Science required, master’s or PhD preferred.
• 10+ years of relevant industry experience in bioanalytical or pharmaceutical company.
• Subject matter expert in GLP compliance, regulations, and requirements.

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 for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.

Why Kelly® Science & Clinical?

Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the world’s most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goals-it’s the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed.

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 is committed to providing equal employment opportunities to all qualified employees and applicants regardless of race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or any other legally protected status, and we take affirmative action to recruit, employ, and advance qualified individuals with disabilities and protected veterans in the workforce. Requests for accommodation related to our application process can be directed to the Kelly 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 may use AI-powered tools during the recruitment and hiring process. For full details, including how Kelly uses AI, your rights, and how to request a reasonable accommodation, visit the Recruitment Artificial Intelligence Notice.