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