Mastercontrol Jobs in Colorado (NOW HIRING)

Regular Full-Time, Boulder, CO, US

Salary Range: $115,000.00 To $125,000.00 Annually

Reporting into Quality Assurance, this role 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.

• 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.
• Develop and maintain supplier relationship and performance programs, including Supplier Relationship Management, 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.
• 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.

Required:

• Bachelor’s Degree (BS) with 12 years of related experience and/or training; or an equivalent combination of education and experience, including experience in a manufacturing environment.
• Previous experience in Supplier Management and external Quality Auditing is desirable.
• Proficiency with SAP (or similar ERP system) and Microsoft Office Suite.

Preferred:

• CSQP or CSPC accreditation.

• 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, ANSI, ISO, and other industry standards.
• Strong analytical, organizational, and scheduling skills, and creative problem‑solving skills.
• High level of interpersonal skills with strong negotiation abilities and contract development experience.
• Proficiency 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.

• 401(k) matching – Corden Pharma will contribute 100% of the first 6% – 100% vested after 2 years of service.
• Critical Illness Insurance.
• Disability Insurance.
• Employee Assistance Program.
• Flexible Spending Account.
• Health Insurance PPO/HSA.
• Hospital Indemnity Plan.
• ID Theft Protection.
• Life Insurance.
• Tuition Reimbursement.
• Wellness Program.
• Vision Insurance.

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.