Director of Scientific Affairs Job Listing at Kelly Services in Alameda, CA (Job ID 9543386)

Description

Director of Scientific Affairs – Bay Area

Type: Direct Hire
Shift: M-F 8a-5p
Salary: 200K-250K + DOE

The Senior Director will lead QA compliance across GCP, PV, and GLP functions, ensuring data integrity through risk-based audits and Quality Risk Management (QRM). Key responsibilities include tracking metrics, driving continuous improvement, and aligning QA strategies with business goals. This role will serve as the primary QA liaison, managing communication between teams and ensuring compliance with global regulatory standards. The Director will foster cross-functional partnerships to support product development, clinical operations, and regulatory objectives.

Key Responsibilities:

• Develop and maintain comprehensive GCP/PV/GLP QA programs, ensuring non-clinical and clinical trials comply with regulatory guidelines.
• Serve as a primary business partner for Product Development, offering guidance on data integrity and risk management.
• Implement Quality Risk Management (QRM) to guide audit planning, audit frequency, and tracking of findings to ensure regulatory compliance.
• Lead inspection readiness activities, including mock inspections, vendor audits, and Health Authority inspections.
• Provide QA review and approval of clinical trial documentation and regulatory submissions.
• Identify and escalate critical quality issues, driving swift resolution in the best interest of the company.
• Represent QA in strategic business discussions, ensuring alignment with core goals and pipeline deliverables.
• Develop and execute QA strategies that align with business needs, managing complex issues and providing leadership to the QA team.

Supervisory Responsibilities:

• Lead and mentor a team of QA professionals.
• Oversee cross-functional teams when necessary.

Qualifications:

• Bachelor's degree in Biology, Computer Science, Education, or a related field with 15+ years of experience, or
• Master's degree with 13+ years of experience, or
• PhD with 12+ years of experience in relevant fields.
• Extensive knowledge of cGxP (GCP, PV, GLP), drug development, and global regulatory requirements.
• Proven ability to apply broad expertise to develop impactful company objectives and measurable outcomes.
• Strong analytical and problem-solving skills, with the ability to create technical or business solutions for complex issues.
• Excellent communication skills, capable of translating complex concepts across organizational levels.

Desired Experience:

• In-depth understanding of regulatory policies and guidance.
• Experience in managing and resolving quality issues in a fast-paced environment.
• Demonstrated success in leading cross-functional teams and driving continuous improvement initiatives.

This position offers an opportunity to influence key aspects of quality assurance, support business strategy, and ensure compliance with global regulatory standards in a highly collaborative environment.


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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 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.

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