QA Compliance Leader: Regulated Health & Quality

Opella Healthcare Group; Pine Brook (NJ); Hybrid; USD 86,000 - 120,000; Full time

Job summary

Opella is seeking a QA Compliance Specialist in Pine Brook, NJ to lead end-to-end quality initiatives across our self-care brands. You will drive investigations, CAPAs, audits and training, partnering with suppliers and internal teams to strengthen regulatory compliance and product quality.

You have a technical degree and 3+ years in regulated quality roles, strong analytical skills and excellent communication, ready to mentor others and advance a culture of quality.

Qualifications

• Bachelor’s degree in a technical discipline with 3+ years of quality compliance experience.
• Experience with FDA, cGMP/GDP regulatory requirements and dietary supplement regs preferred.
• Experience conducting deviations, investigations and OOS reports to support compliance.

Responsibilities

• Lead end-to-end product complaint process including intake, evaluation, investigation coordination and closure.
• Collaborate with internal teams and suppliers for timely investigations and CAPAs.
• Lead deviation and OOS investigations with root cause analyses and timely resolution.
• Maintain quality documentation, SOPs and change controls, and support audits.

Skills

Quality compliance

FDA regulations

Root cause analysis

Analytical thinking

Communication skills

MS Office

Education

Bachelor's degree in a technical discipline

Tools

Quality management software

Document control systems

Job description

Opella is seeking a QA Compliance Specialist in Pine Brook, NJ to lead end-to-end quality initiatives across our self-care brands. You will drive investigations, CAPAs, audits and training, partnering with suppliers and internal teams to strengthen regulatory compliance and product quality.

You have a technical degree and 3+ years in regulated quality roles, strong analytical skills and excellent communication, ready to mentor others and advance a culture of quality.