Sr. Supplier Quality Management Specialist

Corden Pharma Colorado• Boulder, CO, US, CO

10h•$115,000 - $125,000•Onsite

About The Position

CordenPharma 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. Our People Vision We strive for excellence. We share our passion. Together, we make a difference in patients' lives. SUMMARY 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.

Requirements

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.
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.
Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists.
Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
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

Nice To Haves

Previous experience of Supplier Management and external Quality Auditing is desirable, but not essential.
CSQP/CSPC accreditation preferred.

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
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), 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.

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