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What are the key skills and qualifications needed to thrive in Product Manufacturing, and why are they important?

To thrive in Product Manufacturing, a solid understanding of production processes, quality control, and safety protocols is essential, often supported by a relevant technical degree or vocational training. Familiarity with manufacturing equipment, ERP systems, and industry certifications like Six Sigma or Lean Manufacturing are highly valued. Strong attention to detail, teamwork, and effective problem-solving skills help individuals excel in this environment. These competencies ensure efficient production, high-quality output, and the ability to adapt to process improvements and challenges.

What are some common challenges faced in a Product Manufacturing role and how can they be managed?

Product Manufacturing professionals often encounter challenges such as maintaining quality standards while meeting tight production deadlines, adapting to changes in demand, and troubleshooting equipment issues. Effective communication with team members and other departments, such as engineering and quality assurance, is key to quickly resolving issues and keeping production on track. Utilizing lean manufacturing principles and continuous improvement strategies can help teams address inefficiencies and reduce waste, contributing to a smoother workflow and better product outcomes.

What is product manufacturing?

Product manufacturing is the process of producing goods on a large scale using labor, machinery, tools, and chemical or biological processing. It involves transforming raw materials into finished products that are ready for sale or distribution. This process can include designing, engineering, assembling, and quality testing to ensure products meet required standards. Product manufacturing is a critical part of many industries, including electronics, automotive, food, and textiles.

What is the difference between Product Manufacturing vs Product Assembly?

AspectProduct ManufacturingProduct Assembly
CredentialsTechnical certifications, manufacturing trainingBasic technical skills, assembly training
Work EnvironmentFactories, production linesWorkstations, assembly lines
Industry UsageMass production, large-scale factoriesFinal product setup, component fitting

Product manufacturing involves the entire process of creating products from raw materials, including designing, fabricating, and testing. Product assembly focuses on putting together components to complete the final product. While manufacturing covers the broader process, assembly is a key step within it, often requiring less specialized credentials but essential for completing the product.

What are the most popular job types at Until?
    What are the most popular categories at Until?
    Infographic showing various Product Manufacturing job openings at Until in the United States as of May 2026, with employment types broken down into 100% Full Time. Highlights an 100% Physical job distribution.

    Head of Quality & Regulatory Affairs (San Francisco)

    Until

    San Francisco, CA • On-site

    $180K - $350K/yr

    Full-time

    This job post has expired today. Applications are no longer accepted.

    Job description

    Get AI-powered advice on this job and more exclusive features.

    This range is provided by Until. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

    Base pay range

    $180,000.00/yr - $350,000.00/yr

    We are seeking a Head of Quality & Regulatory Affairs to own and scale our quality system and regulatory strategy as we advance from pre-clinical development into clinical trials and early commercialization. This role is both strategic and hands‑on. You will design and implement a fit‑for‑purpose QMS, define regulatory pathways, lead agency interactions, and act as the internal authority on quality, compliance, and risk. You will be a core member of the leadership team and a key partner to R&D, Manufacturing, Clinical, and Operations.

    Key Responsibilities
    • Design, implement, and maintain a scalable Quality Management System (QMS) aligned with FDA (21 CFR 820, 21 CFR 210/211 as applicable), ISO 13485 / ISO 9001 (as appropriate), GLP / GCP / GMP interfaces
    • Own quality governance including SOPs, change control, CAPAs, deviations, complaints, risk management (ISO 14971), document control and training systems
    • Serve as the final authority on quality decisions, balancing speed with compliance
    • Lead internal audits and support external audits, inspections, and partner diligence
    • Define and own the regulatory strategy across product lines (device, biologic, combination product, or hybrid pathway as applicable)
    • Lead FDA interactions including Pre‑Subs / Q‑Subs, IND / IDE strategy (as applicable), briefing documents and meeting leadership
    • Advise leadership on regulatory risk, sequencing, and trade‑offs
    • Interface with global regulators as needed (EMA, MHRA, etc.)
    • Embed quality and regulatory thinking early into: R&D and preclinical study design, manufacturing process development, vendor qualification and tech transfer
    • Partner closely with R&D / Preclinical, Clinical, Manufacturing & Supply chain, Operations & Program Management
    • Act as a translator between technical teams and regulators
    • Initially operate as a player‑coach / IC
    • Hire and develop QA and RA team members over time
    • Establish external partner strategy (consultants, CROs, notified bodies, etc.)
    • Build systems that will scale through clinical trials and toward commercialization
    Qualifications
    • 5+ years of experience in Quality, Regulatory Affairs, or combined QA/RA in biotech, medtech, or combination products
    • Direct experience building or scaling a QMS in an early‑or mid‑stage company
    • Hands‑on experience leading FDA interactions (Pre‑Sub, IND, IDE, or equivalent)
    • Strong working knowledge of FDA regulations (21 CFR 820, 210/211, 11 as relevant), ISO 13485 and risk management frameworks
    • Track record of sound judgment in ambiguous, fast‑moving environments
    • Ability to operate at both strategic and execution levels
    Preferred / Nice To Have
    • Experience with IDE, first‑in‑human or novel modalities
    • Combination product or platform technology experience
    • Prior inspection or audit leadership experience
    • Experience in organ preservation, devices, biologics, or translational research (context‑dependent)

    We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.

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