Pharma FDA Compliance Lead - Quality Readiness

Aequor; Fall River (MA); On-site; USD 120,000 - 160,000; Full time

Job summary

Aequor is seeking a Pharmaceutical FDA Liaison to ensure QA activities fully comply with FDA rules and cGMP standards. You will drive inspection readiness, manage CAPAs, and lead regulatory responses across the site quality system.

Responsibilities include coordinating audits, submitting FARs, guiding recalls, maintaining document control, and training staff to uphold regulatory compliance and data integrity during audits.

Qualifications

• Bachelor's degree in chemistry, pharmaceutical sciences, quality management or related field.
• Minimum of 10 years in QA/dept or QC lab in pharma manufacturing.
• Minimum of 2 years supervisory experience for hourly and salaried staff.
• Working knowledge of cGMP and regulatory guidelines.

Responsibilities

• Close audit observations via CAPA, with timely closure and effective corrective action.
• Prepare, review, and submit FARs per FDA requirements.
• Lead product recalls with cross-functional coordination and regulatory compliance.
• Oversee document control and ensure data integrity across records.
• Ensure timely submission of documents and audit readiness for inspections.
• Maintain continuous inspection readiness through proactive quality oversight.
• Develop and manage the site internal audit program and follow-up actions.
• Investigate site-wide data integrity issues to meet regulatory expectations.
• Interpret FDA regulations and guidance across site quality systems.
• Coordinate training and cross-functional meetings to drive compliance.

Skills

Quality Assurance

Regulatory compliance

cGMP knowledge

Data integrity

Document control

CAPA management

FDA inspections

Training management

Education

Bachelor's degree in Chemistry or Pharmaceutical Sciences

Tools

Computerized systems validation

Job description

Aequor is seeking a Pharmaceutical FDA Liaison to ensure QA activities fully comply with FDA rules and cGMP standards. You will drive inspection readiness, manage CAPAs, and lead regulatory responses across the site quality system.

Responsibilities include coordinating audits, submitting FARs, guiding recalls, maintaining document control, and training staff to uphold regulatory compliance and data integrity during audits.