Director of Quality Assurance, GLP QAU

Director, GLP Quality Assurance & Compliance

Building a Culture of Quality & Compliance in a Leading In Vivo Research Facility

Company Overview

We are a pioneering research organization dedicated to

translational medicine , bridging the gap between research and real-world applications to improve human health. As we expand our

in vivo research capabilities , including a variety of

preclinical studies , we are seeking an experienced

Director, GLP Quality Assurance & Compliance

to establish and lead a

Quality Assurance Unit (QAU) . This role will be critical in ensuring full

Good Laboratory Practice (GLP) compliance

and fostering a culture of quality across all research operations.

Position Overview

The

Director, GLP Quality Assurance & Compliance

will

design, implement, and oversee a Quality Assurance Unit (QAU)

that ensures research integrity and compliance with

GLP regulations ,

FDA ,

USDA ,

AALAC

and

21CFR Part 11

standards. The organiztion will start out on a paper based system and eventually move to a system like Pristima or Provantis. This role will be starting out from a fresh, bare facility and brought up to full compliance. Reporting to the

Test Faciliyt Manager , this leader will develop policies, oversee audits, and guide the organization through regulatory inspections. Additionally, they will play a key role in

supporting in vivo research protocols and procedures procedures , ensuring that all processes align with in vivo and in vitro

GLP studies and animal welfare regulations .

Key Responsibilities

1. Establishing & Leading the Quality Assurance Unit (QAU) Develop and implement the

Quality Assurance Unit (QAU)

to provide

independent oversight

of

nonclinical in vivo research and surgical studies . Establish robust

SOPs, policies, and procedures

to align the

entire facility

with

GLP principles

and

regulatory best practices of an in vivo and in vitro preclinical testing facility . Design a

structured audit program , including

facility inspections, process reviews, data integrity assessments, and study audits

to drive

continuous improvement . Ensure that

all study documentation, electronic records, and data management systems

adhere to

21CFR Part 11

and

GLP-compliant

guidelines. Develop mechanisms for

root cause analysis

and

Corrective and Preventative Actions (CAPAs)

to address

compliance gaps . 2. Quality Oversight of In Vivo and In Vitro Research Operations

Provide regulatory and quality

oversight of in vivo preclinical studies , ensuring adherence to

GLP regulations and animal welfare standards (USDA, OLAW, AALAC, IACUC) . Implement

QA/QC processes for research and surgical procedures , ensuring proper

sterility controls, aseptic technique documentation, and procedural compliance . Work with veterinary and scientific staff to

enhance procedural accuracy, maintain study integrity, and prevent deviations

from protocols. Ensure all

study personnel, veterinary teams, and surgical staff

are trained on

GLP principles , and

ethical research conduct . Oversee the implementation of a

data integrity program

for preclinical research,

including audit trails, validation procedures, and security measures

for electronic records. 3. Regulatory Compliance & Risk Management

Serve as the primary

regulatory liaison

for

FDA, USDA, and external auditors , ensuring the

facility is always inspection-ready . Maintain full

separation and independence from study personnel , ensuring

unbiased quality assurance

and compliance verification. Identify and

mitigate compliance risks , reporting

critical quality issues

to senior leadership and advising on remediation strategies. 4. Team Leadership, Training & Continuous Improvement

Recruit, train, and develop a

high-performing QAU team , including

QA auditors and compliance specialists

to support facility-wide GLP adherence. Implement

internal training programs

to foster a

culture of quality awareness , ensuring all personnel understand

GLP expectations and regulatory requirements . Collaborate with IT and

software development teams

to implement

electronic systems

that support

GLP compliance and data security . Design and implement a paper based system to serve as the backbone for a future electronic system. Monitor

emerging regulatory trends

and continuously refine

QA/QC programs

to maintain

best-in-class compliance practices . Qualifications

Education & Experience

Bachelor's degree in a

scientific discipline

(Biology, Pharmacology, Chemistry, Veterinary Sciences, etc.); advanced degree (DVM, PhD, MD) preferred. 8+ years of

GLP-regulated experience

in a

preclinical research, contract research organization (CRO), or biopharmaceutical setting . 4+ years in

GLP quality assurance , with a

demonstrated ability to build and lead a QAU . 2+ years of

managerial or supervisory experience

in quality assurance, regulatory affairs, or compliance oversight. Technical & Leadership Competencies

Expertise in GLP compliance

with a strong understanding of

21CFR Part 11, electronic records/data integrity, and regulatory expectations . Experience

developing and implementing quality programs as well as daily execution

for

in vivo preclinical research, surgical procedures, and regulatory compliance . Strong analytical and

problem-solving skills

to assess

complex compliance issues

and recommend effective solutions. Exceptional

communication, leadership, and cross-functional collaboration skills . Ability to

thrive in a fast-paced, evolving research environment , balancing

compliance demands with operational efficiency . What We Offer

A

pivotal role in shaping GLP compliance

and

preclinical research quality

at a cutting-edge research facility. Competitive

compensation and benefits package . Professional development and training opportunities

to enhance expertise in

regulatory compliance and quality systems . A

collaborative, innovative work environment

dedicated to

scientific excellence and ethical research .

Join Us!

If you are an experienced

GLP Quality Leader

with a passion for

building world-class quality programs

and

ensuring compliance in in vivo research non-clinical studies , we invite you to apply. Help us advance

preclinical science

while upholding the highest standards of

quality, integrity, and regulatory excellence .