GMP Quality Manager

ABM•Bradley, IL

1d•Onsite

About The Position

The GMP Site Quality Manager ensures that ABM’s GxP-regulated services delivered under the Facilities Services contract at client site comply with cGMP regulations, Client Quality Management System (QMS) requirements, and client contractual obligations. Operating within a multi-layer governance model this role provides on-site quality oversight of ABM personnel and subcontractors while serving as the primary quality liaison across all parties. The position is accountable for maintaining compliance, audit readiness, and effective execution of quality systems within ABM’s defined scope. Compensation: $80, 000 annual salary (US Dollars) The pay listed is the salary range for this position. Any specific offer will vary based on the successful applicant’s education, experience, skills, abilities, geographic location, and alignment with market data. You may be eligible to participate in a Company incentive or bonus program Benefits: ABM offers a comprehensive benefits package. For information about ABM’s benefits, visit Benefits | Staff & Management

Requirements

Bachelor’s degree (or equivalent experience).
3+ years in GMP-regulated environments (biologics/plasma preferred).
Experience in: Outsourced / facilities services models Multi-party governance (client–prime–subcontractor) Regulatory inspections and audit support
cGMP regulations (FDA 21 CFR 210/211, 600 series)
Quality systems: deviation, CAPA, change control
GMP facilities/utilities environments
CMMS platforms (e.g., Maximo, SAP PM)
Vendor/contractor quality oversight
Interface management and influence without authority
Strong understanding of contractual quality obligations
Root cause analysis and risk assessment
High rigor in documentation and compliance
Ability to operate effectively in matrixed, multi-company environments
Timely closure of deviations and CAPAs
High GDP compliance and documentation accuracy
Training compliance across ABM personnel
Reduction in interface-related quality events
Positive audit and inspection outcomes
Clear management of GxP responsibilities across client and ABM
Strong collaboration with client QA
Proactive identification and escalation of compliance risks
Effective translation of regulatory expectations into operational execution

Responsibilities

GMP Compliance & Quality Systems
Ensure ABM services comply with: Client QMS and procedures Client governance and work control processes Applicable cGMP regulations (FDA, EMA)
Enforce Good Documentation Practices (GDP) across all ABM-controlled records.
Maintain clear control of GxP boundaries within subcontracted scope.
Support and coordinate ABM involvement in: Deviations / non-conformances CAPAs Change controls impacting GxP services
Ensure investigation inputs are timely, technically sound, and aligned with client expectations.
Track cross-functional actions across ABM, and client site to ensure clear ownership and closure.
Audit & Inspection Readiness
Maintain continuous audit readiness within a client-controlled QMS environment.
Support regulatory (FDA) inspections.
Act as ABM SME during inspections, clearly articulating: Scope and responsibilities under subcontract GMP control measures
Ensure timely closure of audit findings related to ABM services.
Interface & Governance Management
Serve as ABM’s primary quality interface to client QA.
Participate in governance forums, including tier meetings and deviation/CAPA reviews.
Escalate risks where misalignment across organizations may impact compliance.
Ensure clarity in roles, responsibilities, and decision-making across the three-party model .
Training & Workforce Compliance
Ensure ABM personnel meet: Client GMP training requirements Client procedural expectations Role-specific technical qualifications
Maintain visibility of training compliance across systems and address gaps in shared ownership.
Vendor & Subcontractor Oversight
Ensure ABM subcontractors comply with client requirements.
Oversee vendor documentation, permits, and GMP behaviors.
Escalate vendor performance and compliance risks through appropriate governance channels.
Drive improvements to reduce repeat events and strengthen compliance reliability.