Job Description

Base Pay Range

$125.00/hr - $175.00/hr

Key Responsibilities

• Serve as the companys GLP Quality leader and primary QA representative for all GLP-regulated and GCLP-compliant activities.
• Establish, maintain, and continuously improve a risk-based GLP Quality System supporting internal and outsourced laboratory operations.
• Partner closely with Nonclinical, Bioanalytical, and Translational Sciences teams to ensure data integrity, regulatory compliance, and scientific rigor.
• Lead regulatory inspection preparation and hosting, including direct interaction with global health authorities (FDA, EMA, MHRA, etc.).
• Oversee vendor qualification, auditing, and ongoing oversight of GLP/GCLP labs and CRO partners.
• Develop, review, and approve SOPs, quality policies, and technical documentation relevant to GLP compliance.
• Manage the CAPA, deviation, and change control programs related to nonclinical and laboratory operations.
• Provide training, mentoring, and guidance to laboratory and QA staff on GLP expectations and best practices.
• Collaborate cross-functionally to ensure alignment between research, development, and quality goals.
• Drive continuous improvement initiatives and implement scalable quality systems as the organization prepares for commercialization.

Qualifications

• Bachelors degree in a scientific discipline (e.g., Biology, Chemistry, Biochemistry, or related field); advanced degree (MS, PhD) preferred.
• 10+ years of GLP Quality Assurance experience in the biopharmaceutical industry, including oversight of internal and external labs.
• Strong understanding of FDA, OECD, and global GLP regulations and GCLP expectations.
• Demonstrated success preparing for and leading regulatory inspections and sponsor audits.
• Handson experience developing and managing QA systems for nonclinical and bioanalytical operations.
• Proven ability to build collaborative relationships across R&D and Quality functions.
• Excellent organizational, communication, and leadership skills with the ability to influence across teams.
• Experience in cardiometabolic, endocrine, or metabolic disease areas strongly preferred.

Seniority Level

Director

Employment Type

Contract

Job Function

Quality Assurance

Industries

Biotechnology Research and Pharmaceutical Manufacturing

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