Quality Manager- GMP Analytical Testing Site

Shift: Monday through Friday, 8:30 AM - 5:00 PM

About the Role

Join our mission to continuously move science forward; to innovate and advance all aspects of our business to improve the health and safety of our communities and lives. This full-time Quality Manager position is located in Lebanon, NJ.

Pace® Life Sciences delivers a comprehensive suite of contract CMC development, CTM manufacturing, regulatory compliance, consulting, and facility support services to the pharmaceutical, biopharmaceutical, and gene therapy industries. Operating across a network of CDMO sites, GMP analytical testing laboratories, and manufacturing support centers, we partner with clients to efficiently advance programs from early development through commercialization.

Responsibilities

• Quality Management System
  • Manage and maintain the company's Quality Management System (QMS), report on critical Key Performance Indicators (KPIs).
  • Ensure compliance with current Good Manufacturing Practices (cGMP), FDA, ICH, ISO, and applicable regulatory requirements.
  • Oversee quality processes including:
    • Deviations
    • CAPAs
    • Change Controls
    • Risk Assessments
    • OOS/OOT Investigations
    • Document Control
    • Training Compliance
• Quality Oversight
  • Provide QA oversight of analytical laboratory operations and GMP testing activities.
  • Review and approve analytical documentation, protocols, reports, investigations, and quality records.
  • Support method validation, method transfer, stability studies, and analytical development programs.
  • Ensure data integrity practices align with ALCOA+ principles and regulatory expectations.
• Audits & Inspections
  • Lead internal quality audits and inspection readiness activities.
  • Serve as primary QA representative during client audits, regulatory inspections, and supplier audits.
  • Manage audit findings and ensure timely implementation of corrective actions.
• Client & Regulatory Support
  • Partner with clients to address quality-related inquiries and support project execution.
  • Review quality agreements and customer requirements.
  • Assist with regulatory filings and quality documentation as needed.
• Leadership & Continuous Improvement
  • Lead and develop members of the Quality Assurance team.
  • Promote a culture of quality, compliance, and continuous improvement.
  • Establish quality metrics and drive initiatives to improve operational effectiveness and compliance.

Requirements

• 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.
• Strong knowledge of:
  • FDA regulations
  • cGMP requirements
  • ICH guidelines
  • Data Integrity requirements
  • Laboratory compliance programs
• Experience managing deviations, CAPAs, change controls, and investigations.
• Excellent written, verbal, organizational, and interpersonal communication skills.

Preferred Qualifications

• Advanced degree in a scientific discipline.
• Experience supporting analytical outsourcing services or contract testing laboratories.
• Experience with electronic quality management systems (eQMS).
• Experience supporting client audits and FDA inspections.

Skills

• Quality and compliance leadership
• Critical thinking and problem solving
• Risk-based decision making
• Attention to detail
• Client-focused mindset
• Cross-functional collaboration
• Continuous improvement orientation

Benefits

• Competitive salary and annual bonus opportunity
• Comprehensive health, dental, and vision benefits
• 401(k) with company match
• Paid time off and company holidays
• Professional development and career growth opportunities
• Collaborative and science-driven work environment
• HSA, wellness program, flexible spending accounts
• Tuition reimbursement
• Employee Assistance program
• Parental leave
• Optional legal coverage and ID theft protection

Pay

$115,000 - $125,000 per year. The salary for this position reflects a variety of factors. Compensation will be determined based on the candidate’s geographic location, relevant experience, education, skills, and alignment with internal equity. Market conditions, budgetary considerations, and organizational compensation guidelines may also influence the final offer.

Schedule

Monday - Friday, 8:30 AM - 5:00 PM

Physical/Mental Requirements

The physical demands described herein are representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Mobility to work in a lab and office setting, use standard office and lab equipment, and stamina to sit for extended periods of time.
• Exerting up to 20 pounds of force occasionally and/or up to 10 pounds of force frequently to lift, carry, push, pull, or move objects.
• Vision to read printed materials and computer screens.
• Hearing and speech to communicate in person or over the telephone.

Working Environment

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