QA Manager

Apex Systems; Lebanon (NJ); On-site; USD 120,000 - 170,000; Full time

Benefits offered by this job

ESPP

401K program with company match

HSA (Health Savings Account)

Employee Assistance Program (EAP)

Certification discounts

Job summary

Everforth Apex in Lebanon, New Jersey, is seeking a QA Manager to lead a growing quality team onsite. You will own the QMS, mentor staff, and support frequent client audits and regulatory inspections with a strong focus on continuous improvement.

The role requires hands-on GMP/QMS leadership, collaboration with Operations, and a proactive approach to CAPAs, deviations and risk assessments to ensure data integrity and regulatory readiness.

Qualifications

• Bachelor's degree in a related scientific discipline.
• 7+ years of QA experience in pharma/biotech/contract labs.
• 3+ years of leadership experience and GMP/FDA QA leadership.
• Strong knowledge of FDA regulations, cGMP, ICH and lab compliance.
• Experience hosting client audits and regulatory inspections.

Responsibilities

• Manage and maintain the Quality Management System (QMS) with KPI reporting.
• Provide QA oversight of analytical operations and GMP testing activities.
• Lead and develop QA team to foster quality and continuous improvement.
• Serve as primary QA representative during audits and inspections.
• Oversee deviations, CAPAs, change controls, risk assessments, investigations.
• Partner with clients to address quality inquiries and support projects.
• Establish quality metrics and drive operational compliance.
• Ensure data integrity per ALCOA+ principles.

Skills

QA Leadership

GMP Compliance

FDA Regulations

Audit Readiness

Mentoring

Education

Bachelor's degree in Chemistry, Biology, Pharmaceutical Sciences

Tools

eQMS

Job description

Job#: 3049459 Job Description:

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.

Required Qualifications

• 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.

Preferred Qualifications

• 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.

Physical Requirements

Mobility to work in a lab and office setting, use standard office and lab equipment, and stamina to sit for extended periods. Must be able to exert up to 20 pounds of force occasionally and/or up to 10 pounds of force frequently. Vision to read printed materials and computer screens, and hearing and speech to communicate in person or over the telephone is required.

Work Environment

Work is performed in a lab and office setting. The role is subject to chemicals, fumes, gasses, and noxious odors in a lab setting.

Everforth Apex is a world-class IT services company that serves thousands of clients across the globe. When you join Everforth Apex, you become part of a team that values innovation, collaboration, and continuous learning. We offer quality career resources, training, certifications, development opportunities, and a comprehensive benefits package. Our commitment to excellence is reflected in many awards, including ClearlyRateds Best of Staffing® in Talent Satisfaction in the United States and Great Place to Work® in the United Kingdom and Mexico.

Benefits

• Everforth Apex offers a range of supplemental benefits, including medical, dental, vision, life, disability, and other insurance plans that offer an optional layer of financial protection.
• We offer an ESPP (employee stock purchase program) and a 401K program which allows you to contribute typically within 30 days of starting, with a company match after 12 months of tenure.
• Everforth Apex also offers a HSA (Health Savings Account on the HDHP plan), a SupportLinc Employee Assistance Program (EAP) with up to 8 free counseling sessions, a corporate discount savings program and other discounts.
• In terms of professional development, Everforth Apex hosts an on-demand training program, provides access to certification prep and a library of technical and leadership courses/books/seminars once you have 6+ months of tenure, and certification discounts and other perks to associations that include CompTIA and IIBA.
• Everforth Apex has a dedicated customer service team for our Consultants that can address questions around benefits and other resources, as well as a certified Career Coach.
• You can access a full list of our benefits, programs, support teams and resources within our 'Welcome Packet' as well, which an Everforth Apex team member can provide.

Everforth Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Everforth Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law.

If you require an accommodation under the Americans with Disabilities Act to participate in an interview with a virtual recruiter or to use our website for a search or application, please contact our Benefits Department at [email protected] or 804-523-8228. Please note that this contact information is strictly to be used for medical ADA accommodations and that no other inquiries will be answered.

UnitedHealthcare creates and publishes the Transparency in Coverage Machine-Readable Files on behalf of Everforth Apex Systems.