Sr. Supplier Quality Management Specialist

About the role

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

Responsibilities

• 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
• Evaluate and qualify new suppliers, review documentation and quality systems, and monitor 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

Qualifications

• Bachelor's Degree (BS) with 12 years of related experience and/or training; or equivalent combination of education and experience, including experience in a Manufacturing Environment
• Previous experience of Supplier Management and external Quality Auditing is desirable, but not essential
• Candidate should have a background working with SAP (or similar ERP System) and Microsoft Office Suite
• Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals
• Ability to write routine reports and correspondence
• Ability to speak effectively before groups of customers or employees of the organization
• Ability to calculate figures and amounts such as discounts, interest, commissions, proportions, percentages, area, circumference, and volume

Leadership & Budget Responsibilities

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

Safety & Environmental Responsibilities

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.

Quality Responsibilities

Corden Pharma Colorado (CPC) is a manufacturer of a variety of pharmaceutical products. In following Current Good Manufacturing Practices (cGMP), Corden Pharma Colorado 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 efficacy. CPC’s Quality Management System, which incorporates cGMP, is designed to deliver this quality objective. Attainment is produced through the requisite participation and commitment of all staff across departments and at all levels within the company. cGMP is the part of Quality Management System ensuring products are consistently produced to accurate quality standards. Adherence to clearly defined procedures, in compliance with the principles of cGMP, is required when performing operations across Corden Pharma Colorado.

Core Competencies

• Relevant experience in pharmaceutical/biopharmaceutical/chemical/manufacturing processes and related Quality Assurance, Quality Auditing, and Supplier Management
• Strong working knowledge of cGMP, GLP, good clinical practices, FDA Guidelines, and Points to Consider documents and standards routinely used in the industry (ANSI, ISO, and Federal Standards)
• Strong analytical, organizational, and scheduling skills, and creative problem-solving skills
• High level of interpersonal skills with strong negotiation skills and contract development experience
• Proficient in computer systems such as word processing, spreadsheets, eQMS (MasterControl), and ERP software packages (SAP)
• Strong written and verbal communication, and presentation skills
• High degree of business ethics

Benefits

• 401(k) matching - Corden Pharma will contribute 100% of the first 6% - 100% vested after 2 years of service
• Accident Plan
• Critical Illness Insurance
• Dental Insurance
• Disability Insurance
• Employee Assistance Program
• Flexible Spending Account
• Health Insurance PPO/HSA
• Hospital Indemnity Plan
• ID Theft Protection
• Life Insurance
• Paid Parental Leave
• Tuition Reimbursement
• Wellness Program
• Vacation – Three Weeks 1st Year
• Vision Insurance

Equal Opportunity Employer

Corden Pharma provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws. Corden Pharma embraces fair hiring practices.