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Overview We are seeking an experienced Senior Manager, GCP QA to join our team. This role is crucial for ensuring quality oversight of clinical studies and vendor programs, maintaining compliance with ICH GCP and FDA reg…
Skills: GCP QA, Quality Oversight, Vendor Management, ICH GCP Compliance, FDA Regulatory Requirements
Hillsborough Township, New Jersey, United States · On-site
$17/hr–$25/hr
Labcorp is a global leader in diagnostic testing and drug development solutions, helping healthcare providers, researchers, and patients make informed decisions that advance care. Join us in our mission to improve health…
Skills: Venipuncture, Capillary Techniques, Specimen Collection, Data Entry, Billing Processing
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Morristown, New Jersey, United States · On-site
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Warren Township, New Jersey, United States · Hybrid
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PTC Therapeutics is a global commercial biopharmaceutical company. For over 25 years our team has been deeply committed to a unified purpose: Extending life’s moments for children and adults living with a rare disease. A…
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New Brunswick, New Jersey, United States · On-site
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Princeton, New Jersey, United States · On-site
$125k–$173k/yr
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Rahway, New Jersey, United States · Hybrid
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Princeton, New Jersey, United States · Hybrid
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Rahway, New Jersey, United States · On-site
$117k–$184k/yr
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Somerset, New Jersey, United States · On-site
$400k–$450k/yr
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Skills: Medical Dermatology, Cosmetic Dermatology, Surgical Dermatology, Mohs Surgery, Patient Care
Paramus, New Jersey, United States · On-site
$207k/yr
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Skills: Dementia Management, Cognitive Assessments, Geriatric Care, Clinical Research, Medical Education
Hackensack, New Jersey, United States · On-site
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Skills: Radionuclide Procedures, Image Acquisition, Radiation Protection, Radiopharmaceutical Administration, Equipment Calibration
Middletown Township, New Jersey, United States · On-site
$136/hr–$170/hr
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Princeton, New Jersey, United States · Remote OK
$80k–$130k/yr
SystImmune is a leading and well-funded clinical-stage biopharmaceutical company located in Redmond, WA and Princeton, NJ. It specializes in developing innovative cancer treatments using its established drug development …
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Hackensack, New Jersey, United States · On-site
$400k–$450k/yr
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Warren Township, New Jersey, United States · On-site
$134k–$185k/yr
Title: Cat Portfolio Manager Company: Everest Global Services, Inc. Job Category: Analytics Job Description: About Everest: Everest is a global leader in risk management, rooted in a rich, 50+ year heritage of enabling b…
Skills: Catastrophe Modeling, SQL, Python, C#, Data Cleansing
Union, New Jersey, United States · On-site
$17/hr–$19/hr
Job Title: Veterinary Assistant Reports to: Lead Veterinary Technician FLSA Status: Non-Exempt General Summary: Our veterinary assistants assist veterinary technicians and veterinarians with office visits, interact close…
Skills: Animal Restraint, Vaccine Administration, Patient Monitoring, Client Communication, Medical Record Documentation
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Provide quality oversight and GCP guidance for clinical studies and vendors to ensure compliance with regulatory requirements. Conduct audits of CROs, vendors, and investigator sites while managing risk mitigation strategies and CAPAs.
Requires a bachelor's degree in life sciences or a related field and at least 5 years of experience in GCP QA or compliance. Must have working knowledge of ICH, FDA, EMA, and PMDA guidelines and be willing to travel up to 25%.
We are seeking an experienced Senior Manager, GCP QA to join our team. This role is crucial for ensuring quality oversight of clinical studies and vendor programs, maintaining compliance with ICH GCP and FDA regulatory requirements, and upholding our high standards for data integrity. The ideal candidate will provide advisory and collaborate with clinical study teams and internal departments to assess and mitigate risks associated with vendors.
Additional Information
The base salary range for this full-time position is $135,000 - $165,000. Individual pay is determined by several factors, which include but are not limited to: job-related skills, experience, and relevant education or training. The range does not include the comprehensive benefits, bonus, long-term incentive, applicable allowances, or any additional compensation that may be associated with this role
Shionogi Inc. is an equal opportunity employer supporting individuals with disabilities and veterans. All qualified applicants will receive equal consideration for employment opportunities based on valid job requirements without regard to race, color, religion, sex (including pregnancy), marital status, national origin, age, ancestry, citizenship, disability, genetic information, status as a disabled veteran, a recently separated veteran, Active Duty Wartime or Campaign Badge Veterans, and Armed Forces Service Medal Veterans, or any other characteristic protected by applicable law. It is the policy of Shionogi Inc. to undertake affirmative action for protected veterans and individuals with disabilities in compliance with all federal, state, and local requirements to recruit a diverse pool of protected veteran and individuals with disabilities applicants and to ensure that our employment practices are, in fact, non-discriminatory.
If you are qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation if you are unable or limited in your ability to use or access this website to apply for a vacancy as a result of your disability. You can request accommodations by calling 973-307-3550 or by sending an email to [email protected].
Our mission is to supply the best possible medicines to protect the health and well-being of the patients we serve
Since 1878, we have been committed to developing new treatments to improve patients' lives worldwide. We are helping to address global health challenges such as antimicrobial resistance and COVID-19. Since the 1950s, we have discovered and introduced several novel antibiotics, as well as innovative medications for HIV and influenza. Today, we are developing an investigational oral antiviral for COVID-19 and advancing clinical programs in Fragile X syndrome, acute ischemic stroke as well metabolic disorders and oncology. Our team is driven to impact patient lives. Our partnerships with industry, government agencies, biotech companies and academia help to advance science with the urgency that today's health challenges demand. Through a combination of in-house discovery and strategic partnerships, we continue to deliver firsts for patients in the U.S. and worldwide. See our community guidelines: https://bit.ly/4n3Jhe4
Offices: 300 Campus Drive, Florham Park, New Jersey 07932, US
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