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Gcp Qa Jobs (NOW HIRING)

Shionogi Inc.

Senior Manager, GCP QA

Florham Park, NJ

$135K - $165K/yr

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 ...

Shionogi Inc.

Senior Manager, GCP QA

Florham Park, NJ

$135K - $165K/yr

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 ...

Shionogi Inc.

Senior Manager, GCP QA

Florham Park, NJ · On-site

$135K - $165K/yr

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 ...

Merican

GCP Auditor, Quality Assurance

Paramus, NJ · On-site

GCP Auditor, Quality Assurance Location: Paramus, NJ, 07652 Job Type: Temporary Assignment Duration: 6+ Months Work Type: Onsite Shift: Mon-Fri 9.00 AM-5.00 PM * The GCP Quality Assurance Auditor ...

Madrigal Pharmaceuticals

Position Summary This position will be responsible for GCP/Clinical Quality Assurance activities. The primary responsibilities will be to ensure quality and compliance of Madrigal-sponsored clinical ...

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How much do gcp qa jobs pay per year?

As of Jul 30, 2026, the average yearly pay for gcp qa in the United States is $118,074.00, according to ZipRecruiter salary data. Most workers in this role earn between $83,000.00 and $144,500.00 per year, depending on experience, location, and employer.

What is a GCP QA job?

A GCP QA (Good Clinical Practice Quality Assurance) job involves ensuring compliance with regulatory guidelines in clinical research. Professionals in this role conduct audits, review protocols, and ensure clinical trials adhere to industry standards such as FDA and ICH guidelines. They work to identify, report, and mitigate risks to maintain the integrity of clinical data. GCP QA specialists collaborate with regulatory agencies, clinical teams, and sponsors to ensure ethical and quality-driven research practices.

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

To thrive as a GCP QA, you need a strong understanding of Good Clinical Practice (GCP) guidelines, clinical research processes, and quality assurance methodologies, often backed by a degree in life sciences or a related field. Experience with audit tools, electronic data capture (EDC), and certifications such as RQAP-GCP or similar are highly advantageous. Excellent attention to detail, communication skills, and the ability to work collaboratively stand out as essential soft skills. These capabilities ensure compliance, data integrity, and the smooth execution of clinical trials within regulatory frameworks.

What are some of the typical responsibilities of a GCP QA throughout a clinical trial?

GCP QA professionals are responsible for planning, conducting, and documenting quality audits of clinical trial processes, ensuring compliance with Good Clinical Practice guidelines and regulatory requirements. They review study documentation, identify compliance gaps, and work closely with clinical project teams to implement corrective actions. GCP QA specialists regularly communicate with sponsors, investigators, and regulatory agencies. Their oversight ensures data integrity and subject safety throughout the clinical trial lifecycle, which is vital for successfully bringing new therapies to market.

What cities are hiring for Gcp Qa jobs? Cities with the most Gcp Qa job openings:
What are the most commonly searched types of Gcp Qa jobs? The most popular types of Gcp Qa jobs are:
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Gcp Qa jobs near you
Infographic showing various Gcp Qa job openings in the United States as of July 2026, with employment types broken down into 93% Full Time, 2% Part Time, and 5% Contract. Highlights an 79% Physical, 5% Hybrid, and 16% Remote job distribution, with an average salary of $118,074 per year, or $56.8 per hour.

Director, GCP Quality Assurance

Beeline Medicines

Boston, MA • On-site

Full-time

PTO

Posted 13 days ago

Job description

About Beeline Medicines:
Beeline Medicines is a clinical-stage biotechnology company focused on developing and delivering category-leading precision therapies to transform the lives of people living with autoimmune and inflammatory diseases. With a portfolio of potential best-in-class and first-in-disease therapeutic candidates that directly target key pathways governing dysregulated immunological and inflammatory responses, the Company is developing medicines that have the opportunity to provide durable, life-changing impact. Led by an established executive team and backed by world-class life science investors, each day Beeline Medicines is determined to bring the scientific rigor and operational excellence to get to what matters for patients - realizing a world where people with immune-mediated diseases can live life fully.
Job Summary:
The Director, GCP Quality Assurance is responsible for providing strategic and operational Quality Assurance oversight for Good Clinical Practice (GCP) activities supporting the company's clinical development programs. This role ensures that clinical trials are conducted in compliance with applicable regulatory requirements, company policies, and global GCP standards, with a continuous state of inspection readiness.
The Director partners closely with Clinical Operations, Regulatory Affairs, Pharmacovigilance, Data Management, and external service providers to implement a risk-based quality oversight model across the clinical lifecycle. The role is accountable for GCP quality systems, vendor oversight, audits, and inspection support, and plays a critical role in embedding quality by design into clinical development programs
Work Arrangement & Location:
Hybrid - This position follows a hybrid work schedule, requiring a minimum of two (2) days on-site per week - currently designated as Tuesday and Wednesday. Additional on-site days may be required based on business needs, team priorities, or leadership direction.
Essential Duties and Responsibilities:
  • Develop and implement the GCP QA strategy aligned with clinical development objectives and global regulatory expectations
  • Serve as a key QA partner to Clinical Operations and cross-functional stakeholders on GCP compliance and quality risk management.
  • Promote a strong culture of quality, compliance, and continuous improvement across clinical programs
  • Oversee GCP quality systems including deviations, investigations, CAPAs, change control, documentation, and training related to clinical activities.
  • Ensure GCP processes are phase-appropriate, compliant, and scalable
  • Support the development, review, and approval of GCP-related SOPs, policies, and work instructions.
  • Provide QA oversight for GCP activities conducted internally and by CROs, vendors, and other service providers
  • Lead GCP vendor qualification, audit strategy, and ongoing oversight using risk-based principles.
  • Review and approve GCP-related quality agreements and vendor oversight plans
  • Plan and execute risk-based GCP audits, including CRO audits, investigator site audits, and system audits as applicable.
  • Lead GCP inspection readiness activities and serve as a primary QA contact during health authority inspections.
  • Coordinate inspection preparation, conduct, and follow-up, including responses to regulatory observations.
  • Ensure a sustainable state of inspection readiness across clinical programs.
  • Ensure critical-to-quality considerations are embedded in clinical trial design and execution.
  • Provide oversight of data integrity practices across GCP processes and systems.
  • Identify, assess, and proactively mitigate GCP compliance risks
  • Perform other duties and responsibilities as assigned

Qualifications:
  • Education: Bachelor's degree in a scientific or related discipline; advanced degree preferred.
  • 10+ years of experience in GCP Quality Assurance or Clinical Quality within a biotech or pharmaceutical environment.
  • Strong knowledge of global GCP regulations and clinical trial oversight requirements.
  • Demonstrated experience supporting regulatory inspections and audits.
  • Experience overseeing CROs and other GCP service providers.
  • Experience supporting late-stage or pivotal clinical trials.
  • Strong background in risk-based quality management and inspection readiness.
  • Skilled at influencing without authority; effectively engages senior scientific, clinical, and operational stakeholders to drive alignment on quality priorities and shared accountability for compliance
  • Able to serve as a primary quality representative in regulatory agency interactions and inspections, communicating the company's quality posture with confidence and credibility.
  • Strong cross-functional collaborator who proactively communicates quality risk, escalates issues with appropriate context and urgency, and fosters a culture of transparent, solution-oriented dialogue.

Salary Range:
The expected salary range for this position varies by location and will be communicated based on the country or region in which the selected candidate is hired. Actual pay will be determined based on experience, qualifications, location, and other job-related factors permitted by applicable local law. A discretionary annual bonus and long-term incentive award (e.g., equity) may be available based on individual and Company performance.
Salary Range
$220,000-$284,000 USD
Benefits:
We offer a comprehensive benefits package tailored to the country and region in which you are hired, in compliance with local laws and practices. Benefits may include, but are not limited to:
  • Competitive health and wellness coverage (structure and premiums vary by country)
  • Paid time off, public holidays, and additional leave entitlements in accordance with local requirements
  • Flexible work arrangements / hybrid schedule

Benefits vary by location and are subject to eligibility requirements, local regulations, and plan terms. Specific benefit details applicable to your country or region will be provided during the offer process.
Equal Employment Opportunity:
Beeline Medicines is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity or expression, national origin, disability, age, protected veteran status, or any other characteristic protected by applicable federal, state, or local law.
Reasonable Accommodation:
If you require a reasonable accommodation to participate in the application or interview process, please contact careers@beelinemedicines.com to request an accommodation. We are committed to providing equal access to all candidates.
PrivacyUpon submission of this form I understand that Beeline Medicines is based in the United States and personal data submitted in the form will be transferred and accessed in the U.S., Information about Beeline Medicines privacy practices can be found at Privacy Policy - Beeline Medicines

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