Senior Manager, Quality

unlimited holidays - extra parental leave - fully flexible
Remote: 
Full Remote
Contract: 
Work from: 

Offer summary

Qualifications:

Bachelor’s degree in a scientific discipline such as Pharmaceutical Sciences, Chemistry, or Veterinary Science., Minimum 10 years of relevant pharmaceutical industry experience, with at least 6 years in GxP QA roles., Strong knowledge of FDA CVM regulations, cGMP, and VICH guidelines applicable to veterinary products., Exceptional written and verbal communication skills, with the ability to manage multiple projects in a fast-paced environment..

Key responsabilities:

  • Oversee quality assurance activities related to the development and release of veterinary drug products at external CDMO sites.
  • Review and approve batch records, deviation investigations, and validation documentation from CDMOs.
  • Lead quality risk assessments, audits, and inspections of CDMO facilities to ensure compliance with regulatory requirements.
  • Collaborate with internal teams to ensure quality alignment across product lifecycle stages and manage quality-related communications with CDMOs.

Loyal logo
Loyal Biotech: Biology + Technology Scaleup http://loyal.com/
51 - 200 Employees
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Job description

About Loyal

Loyal is a clinical-stage veterinary medicine company developing drugs intended to extend the lifespan and healthspan of dogs. Our mission is to help dogs live longer, healthier lives.

We’ve already achieved significant milestones on our path to earning FDA approval for the first lifespan extension drug for any species. We have three products in our pipeline and are on track for FDA conditional approval within the next year.

Loyal is a well-funded startup in growth mode. Our team includes scientists, veterinarians, engineers, operators, and creatives. This role will play a key role in supporting our growth strategies.

About the role

We’re seeking an experienced Sr. Manager, Quality to oversee quality assurance activities related to the development, manufacture, testing, and release of veterinary drug products produced at external CDMO sites.

Your work will play a critical role in ensuring the integrity, safety, and quality of Loyal drug products through management of QA programs, audits, and continuous improvement initiatives.

This role is for someone experienced in GxP compliance, technical quality oversight, and vendor management within a virtual environment. The ideal candidate will be comfortable developing and maintaining strong relationships and working collaboratively with both internal and external partners.

You will be reporting to our Director of Quality.

Your daily work will include:
  • Provide QA oversight of CDMOs for the manufacturing, packaging, and testing of drug substances (APIs) and veterinary drug products.
  • Review and approve batch records, deviation investigations, CAPAs, change controls, and validation documentation from CDMOs.
  • Ensure that contract partners operate in compliance with cGMP, VICH guidelines, and applicable regulatory requirements (FDA, EMA, etc.).
  • Lead or support quality risk assessments, audits, and inspections of CDMO facilities.
  • Collaborate with internal cross-functional teams (Regulatory, CMC, Supply Chain) to ensure quality alignment across product lifecycle stages.
  • Support product release by managing the QA review of executed documentation and product disposition decisions.
  • Participate in Quality Management System (QMS) development, implementation, and continuous improvement.
  • Manage quality-related communications with CDMOs and ensure timely resolution of quality issues.
  • Maintain awareness of evolving veterinary pharmaceutical regulations and ensure compliance strategies are updated accordingly.
  • Contribute to the preparation and review of regulatory filings.
  • Lead or support inspection readiness activities.
  • Occasional travel to visit CDMOs and suppliers/service providers.
About you: 
  • Bachelor’s degree in a scientific discipline (Pharmaceutical Sciences, Chemistry, Veterinary Science, or related field)
  • Minimum 10 years of relevant pharmaceutical industry experience, with at least 6 years in GxP QA roles.
  • Broad understanding of drug substance and drug product development and manufacturing, analytical methods and testing, and quality incident management. Experience with solid dosage forms and/or veterinary drug products preferred.
  • Demonstrated success working with external manufacturing partners (CDMOs).
  • Strong knowledge of FDA CVM regulations, cGMP, and VICH guidelines applicable to veterinary products
  • Exceptional written and verbal communication skills
  • Ability to manage multiple projects and priorities in a fast-paced, remote work environment
  • Detailed eye for logistics and problem solving
  • Willing to work and comfortable in a fast-paced startup environment with a dynamic team
  • Familiarity with Google Workspace applications (e.g., Sheets, Slides, etc.) and electronic Quality Management Systems
  • Experience with international regulatory environments (EU, Canada, etc.) a plus
Loyal benefits:
  • Full-coverage health insurance — medical, dental and vision — for you and your dependents
  • $1,000 home office equipment stipend
  • $1,200/year learning budget for books, courses, etc.
  • $250/month wellness budget for gym, cleaners, spa, food, etc.
  • All 3-day weekends are turned into 4-day weekends 🎉
  • Unlimited vacation and paid holidays
  • Paw-ternity leave — adopt a dog and get a day off with your new family member 🐶
  • Competitive salary
  • Company equity options grant for new hires

Salary Range: $140,000 - $170,000

Loyal is founded and led by a first-gen female CEO and is proud to be an equal opportunity employer. We do not discriminate against applicants based on gender, race or color, ethnicity or national origin, age, disability, religion, sexual orientation, gender identity or expression, veteran status, or any other applicable characteristics protected by law. 

Our values
Lean into moonshots

We don’t 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.

Lead with context

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. We empower teams 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.

Required profile

Experience

Industry :
Biotech: Biology + Technology
Spoken language(s):
English
Check out the description to know which languages are mandatory.

Other Skills

  • Quality Assurance
  • Communication
  • Problem Solving

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