QA Compliance Manager: FDA Readiness & Audits

Merck & Co.; Fall River (MA); On-site; USD 86,000 - 113,500; Full time

Job summary

Merck & Co. is seeking a Quality Assurance Compliance Manager in Fall River, MA, to ensure adherence to U.S. FDA regulations and maintain inspection readiness. The role involves managing audit processes, leading product recalls, and developing compliance strategies.

The ideal candidate will have a Bachelor's degree in Chemistry and at least 10 years of experience in a pharmaceutical QA environment. The position offers a salary range of $86,000 - $113,500.

Qualifications

• 10 years of collective work experience in QA Department, preferably in pharmaceutical manufacturing.
• 2 years of supervisory experience in a quality assurance role.
• Direct application of cGMP and regulatory guidelines.

Responsibilities

• Ensure timely closure of audit observations through CAPA.
• Lead product recalls ensuring regulatory compliance.
• Maintain audit readiness and oversee document control operations.

Skills

Quality Management

Regulatory Compliance

cGMP

Team Leadership

Education

Bachelor's degree in Chemistry or related field

Job description

Merck & Co. is seeking a Quality Assurance Compliance Manager in Fall River, MA, to ensure adherence to U.S. FDA regulations and maintain inspection readiness. The role involves managing audit processes, leading product recalls, and developing compliance strategies.

The ideal candidate will have a Bachelor's degree in Chemistry and at least 10 years of experience in a pharmaceutical QA environment. The position offers a salary range of $86,000 - $113,500.