Quality Assurance Manager – ISO/GMP Leader (Onsite)

WhiteCap Search; Florham Park (NJ); Vor Ort; USD 110.000 - 140.000; Vollzeit

Zusammenfassung

WhiteCap Search is seeking an experienced Quality Assurance Manager to establish and sustain QA standards across operations in NJ/NY. You will oversee field audits, drive corrective actions, and ensure compliance with regulatory and contractual requirements.

The role leads ISO 9001/quality system improvements, documents findings, and partners with leadership to implement preventive actions. This onsite position emphasizes strong auditing and process optimization across client locations.

Qualifikationen

• Bachelor's degree in Quality, Engineering, Life Sciences, Pharmaceutical Sciences, or related field.
• ISO 9001 QMS experience and/or certification.
• Formal GMP/cGMP training with knowledge of FDA 21 CFR Parts 210 and 211.
• ISO 19011 auditing methodology/training.
• Experience with QA inspections, internal audits, supplier audits, or compliance audits in regulated environments.
• Experience with CAPA, root cause analysis, deviations/non-conformances, change control, and corrective action verification.
• Knowledge of ICH Q9/Q10 Quality Risk Management and ICH Q10 Pharmaceutical Quality Systems.
• Strong documentation, recordkeeping, and data integrity practices.
• Ability to prepare formal inspection reports and track corrective actions to closure.

Aufgaben

• Develop, implement, and maintain a comprehensive Quality Assurance program across operations.
• Conduct scheduled and unannounced quality audits at client locations.
• Evaluate service delivery against contractual requirements, company standards, SOPs, and client expectations.
• Develop standardized audit forms, inspection checklists, scoring systems, and quality standards.
• Document audit findings and communicate deficiencies to leadership.
• Identify recurring quality issues and recommend corrective and preventive actions.
• Conduct follow-up audits to verify corrective actions are completed and sustained.
• Maintain detailed records of audits, findings, corrective actions, and quality performance.
• Support ISO 9001 processes and external audits/certifications.
• Promote a culture of continuous improvement and accountability.

Kenntnisse

Quality Assurance

ISO 9001

Audit Leadership

CAPA

Root Cause Analysis

Documentation/Data Integrity

GMP / cGMP

Ausbildung

Bachelor's degree in Quality, Engineering, Life Sciences, Pharmaceutical Sciences, or related field

Jobbeschreibung

WhiteCap Search is seeking an experienced Quality Assurance Manager to establish and sustain QA standards across operations in NJ/NY. You will oversee field audits, drive corrective actions, and ensure compliance with regulatory and contractual requirements.

The role leads ISO 9001/quality system improvements, documents findings, and partners with leadership to implement preventive actions. This onsite position emphasizes strong auditing and process optimization across client locations.