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If your skills, experience, and qualifications match those in this job overview, do not delay your application. This range is provided by Kelly. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more. Base pay range $240,000.00/yr - $280,000.00/yr Direct message the job poster from Kelly Senior Recruiter | Biotech Enthusiast and Talent Partner | PhD-level Scientist | Working Parent | Immigrant | Helping scientists answer the… 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 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. 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. 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 Seniority level Seniority levelDirector Employment type Employment typeFull-time Job function Job functionManagement, Quality Assurance, and Science IndustriesBiotechnology Research and Pharmaceutical Manufacturing Referrals increase your chances of interviewing at Kelly by 2x Inferred from the description for this job Medical insurance Vision insurance 401(k) Get notified when a new job is posted. 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