Director GLP Quality

Base Pay Range

$125.00 / hr - $175.00 / hr

Key Responsibilities

Serve as the company’s 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

Bachelor’s 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.

Hands‑on 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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