Senior QA & Compliance Leader: cGMP, FDA Audits

Breckenridge Pharmaceutical; Berkeley Heights (NJ); On-site; USD 120,000 - 145,000; Full time

Benefits offered by this job

Health benefits

Flexible work approach

Competitive compensation packages

Job summary

A pharmaceutical company in New Jersey is seeking a Quality Assurance Manager to oversee cGMP compliance for contract manufacturers and manage quality systems. Ideal candidates should have a Bachelor's degree in a technical field, at least 10 years of experience in the industry, and strong leadership skills. The position offers a salary between $120,000 and $145,000 annually, with additional health benefits and a flexible work approach.

Qualifications

• Minimum 10 years’ experience in the pharmaceutical industry focused on Quality Assurance.
• At least 5 years in a QA-management role.
• Ability to travel domestically and potentially internationally.

Responsibilities

• Assess third-party vendor cGMP compliance.
• Manage the SOP system, including revisions and training.
• Support FDA audits and inspections.
• Manage and resolve batch deviations and reviews.

Skills

Knowledge of drug production quality and compliance

Knowledge of cGMP regulations

Leadership skills

Attention to detail

Communication and interpersonal skills

Education

Bachelor of Science in a technical/science field

Job description

A pharmaceutical company in New Jersey is seeking a Quality Assurance Manager to oversee cGMP compliance for contract manufacturers and manage quality systems. Ideal candidates should have a Bachelor's degree in a technical field, at least 10 years of experience in the industry, and strong leadership skills. The position offers a salary between $120,000 and $145,000 annually, with additional health benefits and a flexible work approach.