Sr. Supplier Quality Management Specialist

Corden Pharma is a leading full-service Contract Development and Manufacturing Organization (CDMO) specializing in active pharmaceutical ingredients (APIs), excipients, drug products (DPs), and packaging. With around 3,000 employees worldwide, we help pharmaceutical and biotech companies manufacture medicines with the ultimate goal of improving people's lives. Our network, spanning Europe and the U.S., provides flexible and specialized solutions across six technology platforms:
Peptides, Lipids & Carbohydrates, Injectables, Highly Potent & Oncology, Small Molecules, and Oligonucleotides. We strive for excellence in supporting this network and are committed to delivering the highest quality products for patient well-being.

We strive for excellence. We share our passion. Together, we make a difference in patients' lives.

Reporting into Quality Assurance and works cross functionally to execute and improve the Supplier Quality Management (SQM) Program and develop alignment across all processes relating to Supplier Risk Management (SRM) for Corden Pharma Colorado.

Include the following. Other duties may be assigned.

• Lead the end-to-end supplier lifecycle management program, including phase-appropriate qualification, risk‑based assessment and classification, performance monitoring, audit strategy, and continuous improvement of supplier quality processes
• Ensure reliable, compliant, and market‑aligned material supply by evaluating and qualifying new suppliers, reviewing documentation and quality systems, and monitoring ongoing supplier performance through metrics, trending, and Quality Management Reviews (QMR)
• Develop and maintain supplier relationship and performance programs, including Supplier Relationship Management (SRM), supplier risk monitoring, second‑sourcing strategies, and ongoing business intelligence related to market trends and CDMO practices
• Plan, prioritize, and execute supplier audits using a risk‑based approach, including defining scopes, performing audits, issuing reports, ensuring timely closure of corrective actions, and maintaining an accurate and compliant Approved Supplier List (ASL)
• Serve as the technical escalation point for supplier quality issues, leading investigations into material defects, deviations, or supply disruptions; coordinating cross‑functional teams; managing supplier‑initiated change evaluations; and ensuring timely issue resolution
• Collaborate cross‑functionally with Supply Chain, R&D, Engineering, Project Management, Regulatory Affairs, and external suppliers to support risk mitigation, strengthen supplier partnerships, improve supplier quality systems, and enhance long‑term supply reliability
• Support external audits, regulatory inspections, and customer reviews by providing supplier qualification records, supplier oversight documentation, and subject matter expertise in Supplier Quality Management and compliance expectations
• Drive continuous improvement across the Supplier Quality Management Program by identifying process enhancements, updating procedures, mentoring SQM Team members, and fostering consistent application of supplier qualification, monitoring, and risk management practices

Provide leadership and harmonization for the management and improvement to the Supplier Quality Management Program across Corden manufacturing sites.

Every individual is personally responsible for the safety and environmental aspects of their activities in the workplace. Each employee is expected to perform their job duties in a safe manner utilizing all their knowledge, training, ability, and experience.

Corden Pharma Colorado (CPC) is a manufacturer of a variety of pharmaceutical products. In following Current Good Manufacturing Practices (cGMP), CPC manufactures in accordance with the US Food and Drug Administration (FDA), International Council for Harmonisation Q7 (ICH), and other global regulations as applicable. This is critical as it is our mission to not place patients at risk due to inadequate safety, quality, or…