EMEAA Lab Senior Quality Assurance Manager

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Sterigenics Germany GmbH
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Responsibilities

Essential Duties:

Quality & Compliance Oversight

Develop, maintain, and continuously improve the quality assurance framework applicable to embedded labs, aligned with Nelson Labs global quality policies and Sterigenics QMS.
Ensure that all embedded lab sites meet accreditation requirements (ISO 17025, GLP, GMP, and other relevant standards, customer, or regulatory audits).
Lead and coordinate internal and external audits (customer, regulatory, certification bodies) and oversee timely closure of findings and CAPAs.
Monitor and review quality metrics across sites (nonconformances, deviations, CAPA effectiveness, trending, root cause, preventive systems).
Oversee embedded‑lab‑specific change control and document control (SOPs, protocols, manuals, validation records).
Participate in management reviews, quality reviews, program steering committees, and escalate risks appropriately.
Provide mentorship, training, and guidance to site QA leads and lab supervisors.

Regulatory Interface & Risk Management

Act as a quality liaison with regulatory affairs, customers, accreditation bodies, and regulatory agencies.
Support method validations, method transfers, and qualification activities from a QA/compliance perspective.
Assess regulatory risk and compliance impact when new testing scopes or upgrades are introduced in embedded labs.
Ensure embedded labs maintain audit readiness, coordinating with global/regional inspection teams.

Continuous Improvement, Standardization & Harmonization

Drive harmonization of quality and QMS practices across embedded labs, ensuring consistency, efficiency, and compliance.
Benchmark and implement quality best practices and lead cross‑site process optimization.
Coordinate cross‑site sharing of lessons learned, audit findings, root cause analysis, and preventive strategies.
Support quality training initiatives (QA workshops, competency development, training alignment).
Ensure data integrity of laboratory records, including software validation and IT infrastructure qualification.

Management & Leadership

Provide leadership, coaching, and direction to site QA personnel; may have direct or matrix reports.
Participate in hiring, performance evaluations, and succession planning for QA roles.
Collaborate closely with operations, lab management, regulatory teams, and global QA functions to align quality and operational goals.
Represent embedded lab QA in global QA forums and cross‑functional teams.

Requirements

Education and experience requirements:

Bachelor's degree in Chemistry, Biology, Microbiology, Biochemistry, Quality, or related discipline required.
Master's degree (e.g., MSc in a scientific, engineering, quality, or regulatory discipline) preferred.
Typically 6+ years of progressive Quality Assurance / Quality Compliance experience in a laboratory, life-science, or testing environment (medical device, pharma, sterilization, microbiology), including demonstrated leadership across multiple sites and/or within a matrix environment.
Strong working knowledge of global accreditation and regulatory standards applicable to testing laboratories (e.g., ISO/IEC 17025, GLP, and applicable national accreditation schemes).
Experience leading internal and external audits (customer, regulatory, and/or accreditation bodies) and managing quality event systems, including CAPA, investigations/deviations/nonconformances, and document control.

Demonstrated ability to influence and drive quality improvements across stakeholder groups (Operations, Laboratory Management, Regulatory, and corporate Quality).

What we offer

A hands-on role with direct impact on EO sterilization operations.
Internal training and development opportunities.
Attractive benefits: company pension scheme, health programs, JobRad, and more.

Company info

Sterigenics Germany GmbH, part of Sotera Health Group, is the global leader in medical product sterilization. Our Wiesbaden site operates under the German Federal Immission Control Act (BImSchG) and employs around 110 staff members.

The Senior Quality Assurance Manager leads the quality assurance, audit readiness, and regulatory compliance oversight for Nelson Labs embedded laboratories across Sterigenics' global facilities. This role ensures alignment, standardization, and compliance with internal and external quality systems and accreditation standards, supporting scientific integrity, regulatory obligations, and business objectives.

Reporting Structure:

Manager (solid‑line report): Senior Manager, Global Quality Compliance (Nelson Labs)
Key partners (no reporting relationship): Director RA/QA, EMEAA (Sterigenics) and site Sterigenics leadership (e.g., Lab Managers / Operations leaders) for alignment on regulatory commitments, audit readiness, and site execution.

This is an independent role with primary accountability to Nelson Labs Global Quality and strong cross‑functional collaboration with Sterigenics RA/QA and site leadership. The role may have direct QA/quality supervisors at individual embedded lab sites reporting directly or in a matrix structure depending on site maturity.