Job DescriptionJob Description
Associate Director, GCP/GLP Quality Assurance Boutique GLP Contract Research Organization (CRO) San Diego, California You know GLP. Now you may be ready to own more of it.
There comes a point in a Quality career when being good at auditing studies is no longer enough.
You want your judgment to matter.
You want to work directly with the Study Directors, scientists, and leaders making decisions rather than being several layers removed from them. You want enough responsibility to influence how Quality operates while remaining close enough to the science to understand what is actually happening.
A growing boutique GLP Contract Research Organization (CRO) in the San Diego area is looking for that person.
We are searching for an
Associate Director, GCP/GLP Quality Assurance to become a trusted member of the organization's Quality function and help support its regulated nonclinical research programs.
This is not a position for someone who wants to step away from the work and simply manage from a distance. It is an opportunity for an experienced GLP Quality professional who is ready for greater ownership. What makes this opportunity different?
In a large CRO, Quality responsibilities can become highly segmented. You may audit one portion of a study, hand it off, and rarely see the complete picture.
This environment is different.
As a boutique CRO, the organization offers the opportunity to work closely with Study Directors, scientists, laboratory personnel, operational leadership, clients, and senior Quality leadership.
You will have visibility across the Quality function and the opportunity to understand the studies and laboratory activities you support from a broader perspective.
You will be expected to exercise independent Quality judgment, communicate directly with scientific teams, and help ensure the organization remains prepared for both sponsor and regulatory scrutiny.
Over time, you should become someone the organization trusts to represent Quality when senior Quality leadership is not immediately available.
That includes being prepared to step in when a sponsor auditor or FDA investigator arrives onsite. You do not necessarily need to have been the primary host for an FDA inspection before.
You do need enough GLP depth, judgment, and inspection exposure to understand what is happening, know what questions need to be asked, organize an appropriate response, and represent the Quality function professionally.
What you will actually do: You will take an active role in the day-to-day operation of the GLP Quality function, including:
- Independently auditing GLP studies, processes and laboratory activities.
- Reviewing protocols, amendments, study conduct, raw data, and final reports for GLP compliance.
- Working directly with Study Directors, scientists, laboratory personnel and operational teams.
- Identifying compliance issues and exercising sound judgment regarding their significance and potential impact.
- Communicating audit findings clearly and helping teams determine appropriate corrective actions.
- Conducting facility, process, equipment, computerized-system, and systems audits in addition to individual study audits.
- Supporting equipment and software validation activities within a regulated GLP environment.
- Participating in sponsor and client audits.
- Supporting FDA and other regulatory inspections.
- Helping maintain ongoing inspection readiness rather than preparing only when an inspection is approaching.
- Supporting investigations, deviations, CAPAs, and Quality-system improvements.
- Interpreting GLP requirements and helping scientific teams apply them appropriately.
- Reviewing SOPs and helping ensure Quality procedures remain effective and compliant.
- Providing Quality leadership when senior Quality leadership is unavailable.
- Helping strengthen and evolve the Quality function as the CRO continues to grow.
The exact mix will evolve with the organization. That is part of the opportunity. The background that tends to translate well.
There is more than one career path that could prepare someone for this position.
You may currently be a:- Senior Quality Assurance Manager
- Quality Assurance Manager
- GLP Quality Manager
- Quality Assurance Supervisor
- Senior QA Auditor
- GLP Auditor
- Associate Director of Quality Assurance
- GLP Quality Consultant
Your current title matters less than the responsibility you have actually carried.
We are particularly interested in people who developed their Quality foundation inside a
GLP nonclinical research environment, including CROs, pharmaceutical companies, and research organizations supporting areas such as:
- Toxicology
- Safety assessment
- DMPK
- ADME
- Bioanalysis
- Pharmacokinetics and toxicokinetics
- Safety pharmacology
- IND-enabling studies
- Other regulated nonclinical laboratory research
Previous CRO experience is particularly valuable. Working in a CRO requires Quality professionals to balance regulatory expectations with study timelines, scientific requirements and sponsor expectations while maintaining the independence and integrity of the Quality function.
We would like to talk with you if you can point to real examples of having:- At least several years of hands-on GLP Quality Assurance experience within regulated nonclinical research.
- Independently audited GLP studies or laboratory activities.
- Applied 21 CFR Part 58 in a working laboratory environment rather than simply being familiar with the regulation.
- Worked directly with Study Directors, scientists and laboratory leadership.
- Made or influenced Quality decisions rather than only documenting findings.
- Participated meaningfully in FDA inspections, sponsor audits or inspection-readiness activities.
- Supported facility, process, equipment or computerized-system audits.
- Worked with equipment and/or software validation in a regulated laboratory environment.
- Communicated difficult findings professionally when Quality and scientific or operational priorities did not initially align.
- Remained close enough to the work to understand how regulated nonclinical studies are actually conducted.
Experience with
Provantis or similar preclinical study-management systems is a plus. People-management experience is not necessarily required.
Functional Quality leadership is. We care considerably more about whether Study Directors, scientists, clients, and leadership trust your Quality judgment than how many people currently report to you.
About FDA inspection experience. Do not rule yourself out because you have never been the person who greeted the FDA investigator at the front door. We are interested in people who have participated meaningfully in the inspection process.
Perhaps you have:- Answered investigator questions.
- Retrieved and explained study or laboratory records.
- Prepared Study Directors or subject-matter experts.
- Supported an inspection room.
- Participated in mock inspections.
- Responded to audit or inspection observations.
- Managed or supported CAPAs.
- Helped maintain a GLP laboratory in a state of inspection readiness.
Those experiences matter. One of the opportunities in this position is to build on that foundation and develop toward greater responsibility during future regulatory and sponsor inspections.
Who may find this particularly interesting?
This could be a compelling next step if you are a strong
Senior QA Auditor or QA Supervisor who has developed deep GLP credibility and is ready to take greater ownership of the Quality function.
It could also make sense if you are already a
QA Manager or Senior Manager at a larger CRO but find yourself in an organization where responsibilities are divided across so many people that you rarely see the complete picture. Perhaps you want to get back into an environment where you know the Study Directors, understand the science, interact with clients, and can see the impact of your Quality decisions. Or perhaps you have moved into consulting or another area of Quality but miss being close to regulated nonclinical research. We are open to the path that brought you here.
We care about what you have learned along the way.
Location: This position is based in the
San Diego, California area and requires someone who can work onsite with the team. Local candidates are strongly encouraged to apply.
Candidates outside the San Diego area may also be considered when there is a strong professional and personal reason for relocation.
Compensation: The anticipated
base salary is approximately $125,000, with flexibility based on the experience, GLP depth, and capabilities someone brings to the position. The overall compensation package also includes additional company benefits.
The goal is not simply to match a title to a salary band. We want to understand the level at which you can contribute and have an open conversation about whether the overall opportunity makes sense.
A final thought. You do not need to match every bullet above.
We would rather speak with someone who has spent years . click apply for full job details
