Quality Expert – Commercial Operations (COM)

Quality Expert – Commercial Operations (COM)

Job Title: Quality Expert – Commercial Operations (COM)

Contract Type: Contract

Start Date: ASAP

Work Model: Hybrid / Remote up to 80% (by agreement)

Right to Work: Must hold valid right to work in Germany (no sponsorship)

Role Overview

We are seeking a senior Quality Assurance professional with strong expertise in commercial batch release processes to support the analysis, redesign, and implementation of compliant release frameworks within a regulated pharmaceutical environment.

This role focuses on EU GMP–compliant commercial release operations , interface management across global functions, and the optimization of local vs. regional release activities , while ensuring inspection readiness and regulatory compliance.

Key Responsibilities

Commercial Release Process Development

• Analyse and evaluate existing commercial batch release processes for medicinal products
• Identify compliance risks and process improvement opportunities , including separation of local and regional release activities
• Design, document, and implement new or optimized release processes aligned with EU GMP, ICH, and FDA requirements
• Define clear roles, responsibilities, governance models, and decision pathways , with strong focus on interfaces

Quality Assurance & Regulatory Compliance

• Ensure ongoing compliance with GMP regulations and quality standards throughout the release lifecycle
• Identify release‑related quality risks, controls, and mitigation strategies
• Support implementation of corrective and preventive measures to prevent deviations

Training & Change Management

• Develop training materials and deliver training sessions on new or updated release processes
• Support change management activities to ensure adoption, sustainability, and stakeholder alignment

Interface & Stakeholder Management

• Collaborate closely with Quality Assurance, Quality Control, Production, Regulatory Affairs, and Supply Chain
• Coordinate with external partners, service providers, and CMOs to ensure seamless release execution

Documentation & Reporting

• Create and maintain SOPs, work instructions, and release‑related documentation
• Prepare status reports, dashboards, and presentations for management and project stakeholders

Audit & Inspection Support

• Support and prepare the organization for regulatory audits and health authority inspections related to commercial release activities

Essential Qualifications & Experience

• Degree in Pharmacy, Life Sciences, Chemistry, or a related scientific discipline
• Proven hands‑on experience with commercial batch release processes
• Strong working knowledge of EU GMP and FDA regulations
• Experience creating, reviewing, and optimizing SOPs and release documentation
• Demonstrated ability to work cross‑functionally in matrix environments
• Experience supporting GMP audits and regulatory inspections
• Independent, structured, and solution‑oriented working style
• Experience separating local vs. regional release activities
• Background in process transformation or change management projects
• Experience delivering training to internal stakeholders
• Exposure to multinational or matrix organizations
• Experience working with external partners or CMOs

Ideal Candidate Profile

• Senior QA professional with strong commercial release expertise
• Comfortable independently analysing, redesigning, and implementing release processes
• Confident engaging and influencing cross‑functional and senior stakeholders
• Pragmatic, compliance‑focused, and process‑driven mindset

Not Suitable For

• Candidates without direct commercial release experience
• Profiles limited to development‑stage or non‑commercial QA
• Pure QP‑only profiles without process or project ownership
• QC‑only or early‑career profiles without release process responsibility

Seniority level

• Associate

Employment type

• Contract

Job function

• Quality Assurance and Management

Industries

• Hospitals and Health Care, Health and Human Services, and Pharmaceutical Manufacturing