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Head of Quality
2 months ago
Head of Quality
San Francisco, CA
The Company:
Our client is an innovative start-up company that is developing advanced, cloud-controlled robotic systems that enable the production of individualized drugs at scale. Their customers include some of the largest global organizations in the advanced pharmaceutical manufacturing space.
Based in San Francisco, California, our client is backed by many top-tier tech and life science investors, including Casdin Capital, Lux Capital, Y Combinator, and more.
Position Overview:
- As the Head of Quality, you will lead the development and implementation of a robust ISO 9001:20XX quality system to ensure compliance with industry standards in a cGMP-regulated pharmaceutical and biopharmaceutical environment. Reporting directly to the CEO, your primary focus will be aligning quality initiatives with customer and regulatory requirements.
As the Head of Quality, your role will include the following:
Quality Leadership:
- Build and lead a quality team to develop and continuously improve the ISO-based quality system.
- Define and implement a comprehensive quality strategy in alignment with ISO 9001:20XX and regulatory standards.
- Provide strategic insight on evolving regulatory requirements in the biopharmaceutical industry.
- Oversee quality agreements, product release processes, and supplier qualification, including managing contract fabricators and key suppliers.
- Policy & Procedure Development:
- Develop and maintain policies and procedures to support a robust quality system, including validation and compliance with 21 CFR Part 11.
- Oversee and automate the document control system, ensuring review and approval of all key documentation (policies, procedures, validation reports, etc.).
- Establish systems for tracking quality trends, audit findings, CAPA progress, and continuous improvement metrics.
- Manage change control systems, deviation systems, CAPA (Corrective and Preventive Actions), and continuous improvement programs..
- Risk & Audit Management:
- Oversee risk management processes, including compliance with GAMP 5 software lifecycle requirements and 21 CFR Part 11 for electronic data integrity.
- Lead internal and external audits to ensure regulatory compliance.
- Host customer audits and manage corrective actions.
- Cross-Team Collaboration:
- Train staff on quality system requirements, validation processes, and regulatory compliance standards.
- Define hardware and software validation requirements and ensure compliance with ISO and regulatory standards.
- Work with the engineering teams to establish product release procedures and achieve CE mark certification.
- Participate in problem investigations and cross-departmental initiatives to support continuous improvement.
- Additional duties may arise based on evolving company priorities.
- This role is critical to driving quality ownership across the organization and ensuring compliance with regulatory standards while fostering innovation and improvement.
Qualifications:
- BS or MS in science or engineering
- A minimum of 7-10 years of increasing quality management experience in the bio/pharmaceutical or medical device industries.
- In-depth knowledge of quality management principles, cGMP’s, equipment and software validation practices with the ability and pragmatism to adapt requirements to a non-regulated equipment manufacturing environment.
- Strong organization and communication skills.
- Excellent interpersonal skills across functional groups and lines of authority.
Additional Qualifications – Considered a plus:
- A diverse background in quality management (ASQ - Quality Engineer).
- Work experience in an ISO 9001 manufacturing environment.
- Experience in cell/gene therapy manufacturing (industry requirements, state-of-the-art quality and regulatory approaches).
- Experience in regulatory affairs (RA). For example, writing communication documents with the FDA and/or the EMA.
