QA Manager
Apex Systems
QA Manager
Location: Lebanon, New Jersey (Onsite) Role Overview We are seeking a QA Manager to lead a quality team. This role requires a leader who can mentor a relatively new team, own quality systems, support frequent client audits, strengthen collaboration between Operations and Quality, and help drive ongoing transformation initiatives. This position is for a professional who is energized by change, process improvement, and team development, rather than simply maintaining daily operations. Key Responsibilities- Manage and maintain the company's Quality Management System (QMS), reporting on critical Key Performance Indicators (KPIs).
- Provide QA oversight of analytical laboratory operations and GMP testing activities, including the review and approval of analytical documentation, protocols, reports, and investigations.
- Lead and develop members of the Quality Assurance team, promoting a culture of quality, compliance, and continuous improvement.
- Serve as the primary QA representative during client audits, regulatory inspections, and supplier audits, managing findings and ensuring timely implementation of corrective actions.
- Oversee quality processes including Deviations, CAPAs, Change Controls, Risk Assessments, and OOS/OOT Investigations.
- Partner with clients to address quality-related inquiries and support project execution.
- Establish quality metrics and drive initiatives to improve operational effectiveness and compliance.
- Ensure data integrity practices align with ALCOA+ principles and regulatory expectations.
- Bachelor's degree in Chemistry, Biology, Pharmaceutical Sciences, or a related scientific discipline.
- 7+ years of Quality Assurance experience in a pharmaceutical, biotechnology, CDMO, or contract analytical laboratory environment.
- 3+ years of leadership or people management experience.
- Hands-on GMP/FDA Quality Assurance leadership experience.
- Strong knowledge of FDA regulations, cGMP requirements, ICH guidelines, and laboratory compliance programs.
- Experience managing deviations, CAPAs, change controls, and investigations.
- Strong client audit experience, including hosting audits and interacting with auditors and customers.
- Collaborative leadership style with the ability to partner effectively with Operations and mentor a team.
- Advanced degree in a scientific discipline.
- Chemistry/laboratory background with progression into QA.
- Experience supporting analytical outsourcing services or contract testing laboratories.
- Experience with electronic quality management systems (eQMS).
- Entrepreneurial mindset and interest in transformational environments.
- Relationship-focused mentality with a collaborative approach to management.
- Ability to influence without authority and build trust across departments.
Vacancy posted 10 hours ago
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