Global Clinical Quality & Compliance Lead

Aequor

United States

On-site

USD 120,000 - 160,000

Full time

3 days ago
Be an early applicant

Get a reply from this employer

Your resume and cover letter, tailored to exactly what they’re hiring for.

Get past ATS filters

Job summary

Aequor is seeking a Site Quality and Compliance Lead to drive quality and regulatory compliance for Phase I-IV trials in the US, including inspections readiness and training program delivery. You will partner with US CDO, Legal, and Med/RA to ensure timely, compliant trial conduct, develop CAPA and risk mitigation, and oversee QA metrics across global CD&O activities.

Applicants should have life sciences degree and strong knowledge of FDA/ICH/GCP, with experience in training and cross-functional

Qualifications

  • Knowledge of FDA, ICH and GCP regulations and best practices.
  • Experience maintaining inspection readiness and CAPA programs.
  • Ability to develop and deliver training to US CD&O colleagues.

Responsibilities

  • Lead quality activities and inspection readiness across US CD&O.
  • Develop and deliver just-in-time training for US CDO.
  • Collaborate with Legal, CD&O, and Med/RA to drive quality in planning and conduct of trials.
  • Identify risks and support corrective actions and trend reporting.
  • Ensure compliance with government regulations and company SOPs.

Skills

Pharma lifecycle knowledge
Regulatory compliance knowledge
Technology trend awareness
Quality management
Cross-functional collaboration

Education

Bachelor's degree in life sciences

Job description

Aequor is seeking a Site Quality and Compliance Lead to drive quality and regulatory compliance for Phase I-IV trials in the US, including inspections readiness and training program delivery. You will partner with US CDO, Legal, and Med/RA to ensure timely, compliant trial conduct, develop CAPA and risk mitigation, and oversee QA metrics across global CD&O activities.

Applicants should have life sciences degree and strong knowledge of FDA/ICH/GCP, with experience in training and cross-functional

Get your free, confidential resume review.

or drag and drop your file here.

Similar jobs

Similar jobs worth comparing

Regulatory Affairs Lead - Clinical Quality & Compliance
Regulatory Affairs Lead - Clinical Quality & Compliance

Aequor Information Technologies Pvt. Ltd. • Ridgefield (CT)

On-site
USD 120,000 - 170,000
Regulatory Affairs Specialist
Regulatory Affairs Specialist

Aequor Information Technologies Pvt. Ltd. • Ridgefield (CT)

On-site
USD 120,000 - 170,000
Clinical Quality and Compliance Lead
Clinical Quality and Compliance Lead

Aequor • United States

On-site
USD 120,000 - 160,000
QA Director: Global Quality Systems & Compliance
QA Director: Global Quality Systems & Compliance

Regulatory Jobs • Portage (IN)

On-site
USD 140,000 - 190,000
Director, Clinical QA
Director, Clinical QA

EPM Scientific • Nutley (NJ)

On-site
USD 190,000 - 230,000
Senior Clinical QA & Compliance Leader (GCP/GLP)
Senior Clinical QA & Compliance Leader (GCP/GLP)

Korro Bio, Inc. • Cambridge (MA)

On-site
USD 190,000 - 230,000
Clinical Quality Assurance Lead — Trials & Compliance
Clinical Quality Assurance Lead — Trials & Compliance

UroGen Pharma, Inc. • Princeton (NJ), Northern (KY)

Hybrid
USD 150,000 - 190,000
Global Clinical QA Director: Strategy & Compliance
Global Clinical QA Director: Strategy & Compliance

4D Molecular Therapeutics • United States

On-site
USD 245,000 - 286,000
Quality Assurance Manager (GCP)
Quality Assurance Manager (GCP)

Enigma Search • South San Francisco (CA)

On-site
USD 120,000 - 150,000
Clinical Quality & Compliance Lead (FSP)
Clinical Quality & Compliance Lead (FSP)

Regulatory Jobs • Durham (NC)

On-site
USD 63,000 - 216,000