Director of CMC Quality Job Listing at Kelly Services in South San Francisco, CA (Job ID US3595986_BH9946086)

Description

Kelly® Science & Clinical is seeking a Director of CMC Quality for a direct hire opportunity with a leading biopharmaceutical company in South San Francisco, CA. If you are driven by the prospect of translating cutting-edge scientific discoveries into tangible advancements and are poised to advance your career, join us as we pioneer progress in the biotechnology and medical device industries.
Workplace: Hybrid, onsite in South San Francisco, CA 3 days/week.
Position Title: Director of CMC Quality
Position Type: Direct hire
Salary: $245,000-285,0000
Position Overview
The Director of CMC Quality will play a pivotal role in overseeing cGMP-related activities to ensure our client's development programs meet regulatory and quality standards. Reporting to the Executive Director of Quality Assurance, you'll collaborate with various GxP functions and will be instrumental in crafting and evolving their quality processes. This role offers the opportunity to lead in shaping their quality assurance strategies for transformative treatment options.
Key Responsibilities

• Develop strategies aligning with regulatory standards for manufacturing high-quality clinical supplies and commercial products.
• Guide internal teams on compliance requirements through various clinical stages to commercialization.
• Oversee Quality and Compliance aspects of internal and vendor GMP activities.
• Lead efforts in developing and implementing Quality programs and policies to ensure regulatory compliance.
• Collaborate on crafting Standard Operating Procedures for CMC and Quality GMP functions.
• Assist in conducting CDMO audits and formulating CDMO Quality Agreements.
• Identify and manage risks related to CMC Quality aspects and devise mitigation strategies.
• Manage the full spectrum of CMC Quality processes including reviewing manufacturing records, assessing testing, and ensuring material disposition.
• Promote quality principles and manage electronic Quality Management Systems initiatives.

Qualifications
Required:

• Bachelor's or Master's degree with 10+ years in quality management within drug development.
• Experience in biopharmaceutical environments, particularly in matrixed project teams.
• Expertise in CMC quality oversight and late-stage development processes.
• Advanced knowledge in GxP Quality principles and regulatory compliance.
• Strong communication and organizational skills with critical and analytical thinking.

Preferred:

• Experience in oligonucleotide CMC quality oversight.

Competencies

• Adaptability in a team-oriented environment.
• Superior interpersonal and communication skills.
• Flexible and capable of thriving in a dynamic, smaller company setting.

If your qualifications align with the requirements of this role, we invite you to apply and take the next step in your career journey. Rest assured, even if this opportunity isn't the perfect match, your profile will remain within our network, ensuring you're connected to a wealth of future opportunities in the field of science and clinical research.
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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 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.

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