Director of Clinical QA Jobs

Loyal

Location:
United States

Category:
IT - Administration

Contract Type:
Not provided

Salary:

175000.00 - 200000.00 USD / Year

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Job Description:

Responsible for building and leading cross-functional quality assurance systems across Loyal teams with an emphasis on FDA-CVM regulatory compliance for drug submissions and products. The work will ensure that all aspects of drug development and clinical operations are high quality, and that any deviations from this are investigated and understood.

Job Responsibility:

Lead the design and execution of the Clinical Quality Assurance strategy to ensure GCP compliance across all studies
Oversee and manage the clinical audit program, including investigator site audits, vendor audits, and internal process audits
Develop, implement, and maintain policies, SOPs, and training programs to support compliance with global regulations (FDA, EMA, VICH-GCP, etc.)
Partner with Clinical Operations, Regulatory, and other cross-functional teams to proactively identify and mitigate quality and compliance risks
Provide quality oversight of vendors and CROs to ensure adherence to contractual and regulatory obligations
Support clinical trial inspections (FDA, EMA, etc.) and lead preparation and response activities
Analyze audit trends and inspection findings to develop continuous improvement initiatives
Serve as the company’s subject matter expert (SME) on GCP-related quality and compliance matters
Review all protocols, data and reports being generated under GLP/GCP
Manage and respond to adverse events (with clin ops) for drug products in the clinic and beyond
Lead, mentor, and develop a team of quality professionals
Help with training new regulatory hires or contractors as appropriate
Building a Quality Assurance Unit process and team as Loyal grows
Design a program and system that is fit for purpose in the current company and can scale to a foreseeable future
Prepare for Quality aspects of Global expansion
Develop, implement, and manage systems to ensure consistency and quality across all Loyal teams
Supporting commercial recalls, adverse events, customer complaints
Being the face of the company for Clinical Quality matters when interfacing with regulatory authorities

Requirements:

Bachelor’s degree in STEM or related field
Minimum 10+ years of experience in Clinical Quality Assurance or Clinical Operations (must be in Animal Health), with at least 5 years in a leadership role
Experience in one of the following regulatory compliance practices: GCP (VICH) or GLP practices (prefer GCP) in animal health pharmaceuticals (not human health)
Willing to familiarize yourself with regulatory practices in which you may not have experience
Track record of success and a broad understanding of current QA practices as they apply to animal health clinical trials and quality assurance
In-depth knowledge of FDA-CVM and other international clinical research regulations
Proven experience in managing audits, inspections, and CAPA systems
Strong leadership, communication, and collaboration skills
Ability to influence cross-functional teams and drive a culture of quality and compliance

What we offer:

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

Additional Information:

Job Posted:
December 10, 2025

Employment Type:

Fulltime

Work Type:

Remote work

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Director of Clinical QA