Director of Quality

Remote/San Francisco /
Product Development & Manufacturing /
Full Time
Loyal is an early stage company developing drugs to help dogs live longer, healthier lives. We apply innovative approaches to tackling aging as a disease that can be slowed and improved with medicines. Loyal is an early stage start-up company and is well funded by top venture capitalists and angels.

Loyal is hiring a Director of Quality. You will build and lead cross-functional quality assurance systems across Loyal teams with an emphasis on FDA regulatory compliance for drug products. 

Loyal is founded and led by a first-gen, female CEO – we encourage and look forward to diverse applicants. 

You will:

    • Broadly work with regulatory consultants, Loyal team, and external vendors to ensure compliance with all regulatory guidelines. 
    • Ensure the proper interface of the quality function to product development, manufacturing, supply chain, and other areas as required.
    • Review all data and protocols being generated under GLP/GMP/GCP. This includes data collection & interpretation.
    • Review study reports and designs. You will help determine appropriate endpoints and outcomes for studies.
    • Review analytical and manufacturing protocols, reports and master batch records.
    • Review executed batch records, certificates of compliance & analysis, and release of product to the clinic as well as eventually the market place.
    • Work with CMC/Res Ops/Dog Ops teams to determine facility audit needs.  All sites that are to be used for GLP/GMP/GCP work should be audited prior to conducting regulated work. This includes development of GMP and GCP facility audit documents.
    • Manage and respond to adverse events and manufacturing defects for drug products in the clinic and beyond.
    • Building out a Quality Assurance Unit team as Loyal grows and requires expansive quality assurance infrastructure.
    • Develop, implement, and manage systems to ensure consistency and quality across all Loyal teams. Examples:
    • Research Ops/Dog Ops QA: Standard checklists/docs for study design, study startup, data review, study closeout, and final reports.
    • CMC QA: Standard checklists/documents for formulation development, GMP manufacturing, and in-vitro data collection.
    • People Ops QA: Standard checklist for new employees (science-based section, ops-based section).
    • Regulatory QA: Checklist for submissions, regulatory hurdles, summary notion pages for regulatory strategy.
    • General QA: Notion standardization for each team to easily update, pipeline and endpoint summaries.

About You:

    • Bachelor’s degree in STEM or related field to pharmaceuticals.
    • Experience in one of the following regulatory compliance practices: GLP, GMP, or GCP practices. Willing to familiarize yourself with regulatory practices in which you may not have experience 
    • 4+ years of progressive quality and/or regulatory affairs experience in an FDA regulated drug and/or medical device environment.
    • Track record of success and a broad understanding of current QA practices as they apply to product development, manufacturing and commercial operations in an FDA regulated environment.
    • Experience applying quality risk management for drug product development and manufacturing. Preferred, but not required. 

How you work and think:

    • Excellent written and verbal communication skills.
    • You have a track record of operating - until the team grows, you will be designing and then executing on all quality assurance systems.
    • Detailed eye for logistics and problem solving.
    • Startup mindset: work fast, low ego, comfortable with uncertainty, and collaborative.
    • You are flexible and excited to adopt quality assurance frameworks to all avenues of the company.

Why join us?

    • Full-time position either remote or based in San Francisco, CA, with flexible hybrid work opportunities
    • Full coverage platinum health insurance (medical, dental and vision) for you and your dependents
    • 401k
    • Generous monthly stipend package for wellness, learning, and fitness
    • Stipend for home office set-up
    • Flexible paid time off & 28 days of whole company holiday per year
    • Paw-ternity leave for pet adoption
    • Dog-friendly office
    • Generous relocation package
    • Welcome kits with Loyal swag
    • Our cash compensation amount for this role is targeted at $140,000 - $200,000/yr. Final offer amounts are determined by candidate experience, expertise, and geographic location and may vary slightly from the above mentioned amounts.
    • Start ASAP
Our Values

Lean into moonshots | We do not settle for incremental change. We have the bravery to take risks and shoot for the impact we want to have.

Opportunity is at the intersection | We lean into combining disciplines, expertises, and perspectives not normally adjacent. We design our organization to facilitate cross-pollination and cross-collaboration. We reject silos.
 
Expertise without ego | Titles do not determine who has a voice. We work on hard, technical problems and have a ton of fun while at it.
 
Learning by doing | Our path is novel and many things we are doing have never been done before. We lean into MVPs and are open to unexpected outcomes.
 
Transparency and rejecting paternalism | We value leading with context. We equip people with the context and background necessary to make their own decisions and act in the best interest of Loyal. Empower team to succeed.

Empathy and respect for all life | Our patients are not just numbers. Our work is intentional, thoughtful, and guided by respect for life. We take our responsibility to pets and pet parents seriously.