Director of CMC Quality (San Francisco)

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Base pay range

240,000.00 / yr - $280,000.00 / yr

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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 level

Director

Employment type

Employment type

Full-time

Job function

Job function

Management, Quality Assurance, and Science

Industries

Biotechnology Research and Pharmaceutical Manufacturing

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Inferred from the description for this job

Medical insurance

Vision insurance

401(k)

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