Quality Manager- GMP Analytical Testing Site

Pace Analytical Services•Lebanon, NJ

7d•Onsite

About The Position

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. 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.

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.

Nice To Haves

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.

Responsibilities

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.
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.
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.
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.
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.