GMP Quality Manager

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 Qualifications & Experience 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 Technical Knowledge 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 Core Competencies 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 Success Measures 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 Critical Success Factors 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 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.