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Gcp Laboratories Jobs (NOW HIRING)

Frontage Laboratories

Lab Technician

Secaucus, NJ · On-site

$18 - $22/hr

Laboratory Manager Per diem Frontage Laboratories Inc. is an award winning, publicly listed (HKSE ... Ensure compliance with safety, quality, and regulatory standards (GCP and internal QA procedures)

Exelixis

Associate GCP/GLP QA Director

Alameda, CA · On-site

$177K - $251K/yr

This leader provides insight and partners with both GCP QA staff and Clinical Operations Quality ... Environment: primarily working in laboratories or in office * Infrequent travel may be required ...

Exelixis

Associate GCP/GLP QA Director

Alameda, CA · On-site

$177K - $251K/yr

This leader provides insight and partners with both GCP QA staff and Clinical Operations Quality ... Environment: primarily working in laboratories or in office * Infrequent travel may be required ...

Exelixis

Associate GCP/GLP QA Director

Alameda, CA · On-site

$177K - $251K/yr

This leader provides insight and partners with both GCP QA staff and Clinical Operations Quality ... Environment: primarily working in laboratories or in office * Infrequent travel may be required ...

Legend Biotech US

Sr. Manager, CQA GLP

Somerset, NJ · Hybrid

... GCP/GLP deviations from study protocols or standard operating procedures. * Support internal and external GLP study audits and general laboratory compliance audits to ensure that laboratories ...

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Gcp Laboratories information

What is a Gcp Laboratories job?

A GCP Laboratories job typically involves conducting clinical trials and laboratory testing in compliance with Good Clinical Practice (GCP) guidelines. Professionals in this role ensure that laboratory procedures adhere to regulatory standards for accuracy, reliability, and ethical conduct. They may work in pharmaceutical companies, research institutions, or healthcare organizations, supporting drug development and medical research. Key responsibilities often include sample analysis, data recording, quality control, and regulatory compliance.

What are the typical day-to-day responsibilities for someone working at a GCP Laboratory?

In a GCP Laboratory, your daily tasks often include preparing, analyzing, and documenting clinical samples with strict adherence to regulatory protocols. You’ll work closely with clinical research teams to ensure data accuracy and regulatory compliance, while also maintaining detailed laboratory records and quality control logs. Collaboration is a key part of the role, as you may participate in team meetings, communicate findings, and help implement process improvements. These responsibilities offer a dynamic work environment focused on supporting vital clinical research projects with precision and integrity.

What are the key skills and qualifications needed to thrive in the Gcp Laboratories position, and why are they important?

To excel at GCP (Good Clinical Practice) Laboratories, candidates typically need a background in life sciences or laboratory technology, with strong knowledge of clinical trials and regulatory compliance. Familiarity with specialized laboratory equipment, Laboratory Information Management Systems (LIMS), and GCP certification are highly valuable. Attention to detail, analytical thinking, and effective teamwork enable professionals to maintain accuracy and integrity in clinical test results. These skills and qualities are critical for ensuring the reliability of data used in medical research and for meeting regulatory requirements.

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Gcp Laboratories jobs near you
Infographic showing various Gcp Laboratories job openings in the United States as of July 2026, with employment types broken down into 94% Full Time, 2% Part Time, and 4% Contract. Highlights an 80% Physical, 5% Hybrid, and 15% Remote job distribution.
Senior Manager, Quality Assurance GCP

Senior Manager, Quality Assurance GCP

Crinetics Pharmaceuticals

San Diego, CA • On-site, Remote

Full-time

Medical, Dental, Vision, Life, Retirement, PTO

Re-posted 18 days ago

Job description

Crinetics is a pharmaceutical company based in San Diego, California, developing much-needed therapies for people with endocrine diseases and endocrine-related tumors. We were founded by a dedicated team of scientists with the simple belief that better therapies developed from rigorous innovation can lead to better lives. Our work continues to make a real difference in the lives of patients. We have a prolific discovery engine and a robust preclinical and clinical development pipeline. We are driven by science with a patient-centric and team-oriented culture. Crinetics is known for its inclusive workplace culture. We are also a dog-friendly workplace. This is an exciting time to join Crinetics as we shape our organization into the world's premier fully-integrated endocrine company from discovery to patients. Join our team as we transform the lives of others.
Position Summary:
The Senior Manager, Quality Assurance GCP will support the Good Clinical Practice (GCP) Quality Assurance (QA) function, and performance of GCP QA operations. The role also supports QA oversight for non-clinical laboratories, including Good Laboratory Practice (GLP). This individual will manage and oversee assigned audits, support regulatory inspections, and support the quality oversight and compliance program at Crinetics Pharmaceuticals.
Essential Job Functions and Responsibilities:
These may include but are not limited to:
  • Manage, oversee, conduct, and report on assigned GCP and GLP qualification and routine vendor audits and others as required (internal system/process, TMF, clinical site, data, and clinical documents).
  • Generate and maintain annual audit programs and manage schedules.
  • Maintain trackers and trend audit findings / CAPAs / resolution processes across programs to identify systemic issues and drive preventive actions.
  • Manage and perform vendor risk assessments.
  • Maintain and archive QA electronic vendor files and audit documentation.
  • Reconcile master vendor tracker and vendor records.
  • Manage GCP and GLP quality agreements with vendors.
  • Attend vendor governance and oversight meetings.
  • Provide GCP guidance and feedback for research and development activities; participate in clinical study team meetings and discuss clinical study-related compliance topics.
  • Identify and escalate significant compliance risks to senior management.
  • Provide guidance and support to Trial Master File activities.
  • Review clinical study documents (protocols, ICFs, study plans, IB, CSR, etc.) of moderate complexity and provide feedback.
  • Foster a collaborative environment that supports GCP compliance and continuous improvement; identify and mitigate potential compliance risks.
  • Review deviations, quality issues, and CAPAs; perform investigations and root cause analysis.
  • Develop and maintain professional cross-functional and cross-departmental relationships.
  • Interpret and apply global regulations of moderate complexity.
  • Identify compliance gaps and develop corrections or improvements.
  • Support inspection-readiness activities and regulatory inspections.
  • Develop, modify, and execute SOPs, Work Instructions, Policies, and/or Job Aids.
  • Develop training materials with minimal support; administer GCP training.
  • Manage multiple projects simultaneously / multi-tasking.
  • Support other quality driven activities and initiatives.
  • Other duties as assigned.

Education and Experience:
Required:
  • Minimum with a Bachelor's degree and at least 12 Years of experience in a QA function within the pharmaceutical/biotech industry (an equivalent combination of experience and education may be considered).
  • Ability to interpret FDA, EU, ICH, and other global GCP regulations.
  • Previous experience conducting GCP QA audits (vendor, investigator site, internal).
  • Provide guidance to auditors and junior level staff; manage and supervise auditor activities and assign tasks and goals.
  • Knowledge working with QMS in vendor management, SOPs, internal audits, deviations, and CAPAs.
  • Demonstrates sound analytical and problem-solving abilities to resolve complex issues that involve numerous components.
  • Excellent collaboration, interpersonal, verbal, and written communication skills.
  • Outstanding organizational, prioritization skills, with attention to detail
  • Good presentation skills to both internal and external audiences.
  • Able to work on issues where analysis of situations or data requires conceptional thinking and in-depth knowledge.
  • Able to facilitate moderate to complex investigations.
  • Has knowledge and experience using a risk-based approach.

Preferred:
  • Experience in GLP and GVP, a plus.
  • Regulatory inspection experience highly desired.
  • Auditor certification and/or RQAP-GCP certification, a plus.

Travel:
You may be required to travel for up to 35% of your time.
Equal Opportunity Employer:
Crinetics is proud to be an Equal Opportunity Employer. We provide equal employment opportunities to all employees and employment applicants without regard to unlawful considerations of sex, sexual orientation, gender (including gender identity and/or expression), pregnancy, race, color, creed, national or ethnic origin, citizenship status, religion or similar philosophical beliefs, disability, marital and civil union status, age, genetic information, veteran status or any personal attribute or characteristic that is protected by applicable local, state or federal laws.
Salary Range
The salary range for this position is: $133,000 - $166,000.
In addition to your base pay, our total rewards program consists of a discretionary annual target bonus, stock options, ESPP, and 401k match. We also provide top-notch health insurance plans for employees (and their families) to include medical, dental, vision and basic life insurance, 20 days of PTO, 10 paid holidays, and a winter company shutdown.

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