Quality Manager- GMP Analytical Testing Site
$115k - $125kPacelabs
- # Quality Manager- GMP Analytical Testing SiteApplyremote type: On-sitelocations: Lebanon, NJtime type: Full timeposted on: Posted Todayjob requisition id: JR262289Shift:Monday through Friday, 8:30 AM - 5:00 PMAre you ready to work making the world a safer, healthier place? 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 is a full-time Quality Manager Position located in Lebanon, NJ, Monday - Friday, from 8:30 a.m. to 5:00 p.m.**Compensation: $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.***Make an Impact. Build a Career.**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.Our experienced industry experts and continued investment in state-of-the-art facilities reflect our commitment to quality, speed, and reliability. United by a shared purpose, we bring meaningful value to patients, healthcare professionals, and health businesses worldwide by delivering services that support a safer, healthier future.**Position Summary**The Quality Assurance Manager is responsible for overseeing and maintaining the Quality Management System (QMS) to ensure compliance with applicable FDA, ICH, USP, ISO and cGMP regulations. This role will lead Quality Assurance activities supporting analytical testing operations, client programs, laboratory compliance, documentation review, audits, change management, investigations, and continuous improvement initiatives.The ideal candidate is a hands-on quality professional with experience in pharmaceutical laboratory environments, contract testing organizations, or CDMO settings, possesses strong knowledge of GMP analytical operations and has the proven ability to collaborate with the operations team to effectively meet the needs of the business.**Key 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.**Qualifications****Required*** 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*** 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.**Key Competencies*** 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**What We Offer*** 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**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; and 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.Find Your Place at Pace - We need you - your curiosity, your talents, and your drive - to help us advance this important work.Benefits When you join Pace, you commit to work that makes a positive impact on our communities and our world. We commit to supporting you with benefits and perks that make a positive impact on your life. Full-time roles are eligible for our comprehensive benefits program which includes competitive salaries, medical, dental vision, 401K retirement savings plan (100% vested immediately in the employer match), life, disability and voluntary benefits, paid time off for holiday, sick and vacation days, HSA, wellness program, flexible spending accounts, tuition reimbursement, Employee Assistance program, parental leave, optional legal coverage and ID theft.***Equal Opportunity Employer****Pace provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, creed, color, religion, genetics, protected veteran status, national origin, sex, age, disability, marital status, sexual orientation, gender identity or expression, citizenship, or any other characteristic protected by federal, state or local laws. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.*
- J-18808-Ljbffr Pacelabs
Vacancy posted 4 days ago
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