Quality Assurance Manager

WhiteCap Search; Florham Park (NJ); Presencial; USD 110.000 - 140.000; Jornada completa

Descripción de la vacante

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.

Formación

• 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.

Responsabilidades

• 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.

Conocimientos

Quality Assurance

ISO 9001

Audit Leadership

CAPA

Root Cause Analysis

Documentation/Data Integrity

GMP / cGMP

Educación

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

Descripción del empleo

A trusted facility solutions partner delivering integrated maintenance and building support services helping organizations create and maintain safe, efficient, high-performing, and welcoming environments.

Position Summary

The position is responsible for establishing, implementing, and maintaining quality assurance standards across operations. This role ensures that service delivery consistently meets company standards, client expectations, contractual requirements, and applicable regulatory and safety requirements.

The role will oversee field quality audits, identify operational deficiencies, develop corrective action plans, monitor compliance, analyze quality trends, and partner with Operations and leadership to drive continuous improvement across client locations. This position is fully onsite in NJ/NY.

Key Responsibilities

Quality Assurance & Auditing

• Develop, implement, and maintain a comprehensive Quality Assurance program across operations.
• Conduct scheduled and unannounced quality audits and inspections 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 appropriate leadership.
• Identify recurring quality issues and recommend corrective and preventive actions.
• Conduct follow-up audits to verify that corrective actions have been completed and sustained.
• Maintain detailed records of audits, findings, corrective actions, and quality performance.

ISO 9001 / Quality Management System

• Maintain and continuously improve quality management processes in alignment with ISO 9001 principles and requirements.
• Develop and maintain quality procedures, work instructions, forms, and documentation.
• Support internal audits and quality management system reviews.
• Identify process gaps and opportunities for improvement.
• Assist leadership with preparation for external audits and certification requirements, when applicable.
• Ensure corrective and preventive actions are properly documented, assigned, tracked, and closed.
• Promote a culture of continuous improvement and accountability throughout the organization.

Operational Quality & Compliance

• Monitor service delivery across multiple client locations.
• Ensure employees and management are following established operational procedures.
• Review staffing, service execution, documentation, equipment, and overall site conditions as part of quality assessments.
• Partner with Operations and Account Managers to address service deficiencies.
• Escalate significant or recurring quality concerns to senior leadership.
• Assist with client inspections, quality reviews, and service improvement initiatives.
• Review client complaints and feedback to identify trends and opportunities for improvement.

Corrective & Preventive Action

• Lead the development and implementation of corrective action plans.
• Conduct root-cause analysis for recurring operational and quality issues.
• Establish measurable action items, responsible parties, and completion deadlines.
• Monitor corrective action progress.

Required Qualifications

• Bachelor's degree in Quality, Engineering, Life Sciences, Pharmaceutical Sciences, or a related field.
• ISO 9001 Quality Management System experience and/or certification.
• Formal GMP/cGMP training with knowledge of FDA 21 CFR Parts 210 and 211.
• ISO 19011 auditing methodology/training.
• Demonstrated experience conducting quality inspections, internal audits, supplier audits, or compliance audits within pharmaceutical, life sciences, manufacturing, or similarly regulated environments.
• Experience with CAPA, root cause analysis, deviations/non-conformances, change control, and corrective action verification.
• Working knowledge of ICH Q9 Quality Risk Management and ICH Q10 Pharmaceutical Quality Systems.
• Strong understanding of documentation, recordkeeping, data integrity, and audit evidence.
• Ability to prepare formal inspection reports, document findings, and track corrective actions through closure.

Preferred Certifications

• ASQ Certified Quality Auditor (CQA)
• ISO 9001 Lead Auditor
• GMP/cGMP Auditor certification
• ISO 19011 Lead Auditor training
• Six Sigma certification
• Additional pharmaceutical quality/compliance certifications

Disclosure: The hourly rates and/or salaries listed may or may not reflect total compensation packages including bonus and fringe benefits, etc., nor are the advertisement(s) posted a guarantee of a certain compensation package for a position or bona fide offer of employment. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.