Job Description

Job Summary

The Quality Commercial Specialist ensures that commercial activities comply with quality standards, regulatory requirements, and internal procedures. This role acts as a key liaison between Quality, Commercial, Sales, Supply Chain, and external partners to ensure that customer-facing operations, contracts, and distribution activities meet all applicable quality and compliance expectations.

Key Responsibilities

Support quality oversight of commercial activities, including sales, distribution, customer agreements, and third-party partnerships Review and approve commercial contracts, quality agreements, and customer requirements for quality and regulatory compliance Ensure adherence to applicable regulations (e.g., GMP, GDP, ISO, FDA, EMA, or other regional requirements as applicable) Act as a quality point of contact for commercial teams, distributors, and customers Participate in audits (internal, customer, and regulatory) related to commercial and distribution activities Manage quality events related to commercial operations, including deviations, complaints, CAPAs, and change controls Support onboarding, qualification, and monitoring of distributors, vendors, and commercial partners Collaborate cross-functionally to resolve quality issues impacting customers or market supply Maintain accurate documentation and records in accordance with quality management system (QMS) requirements Contribute to continuous improvement initiatives within commercial quality processes
Required Qualifications

Bachelor's degree in Life Sciences, Quality, Business, Engineering, or a related field 3+ years of experience in Quality, Commercial Quality, Regulatory, or related roles Strong understanding of quality systems and regulatory requirements relevant to commercial operations Experience working with cross-functional teams and external partners Ability to review contracts and quality agreements from a compliance perspective Strong attention to detail and documentation skills
Job Types: Full-time, Contract