Supplier Quality Management Supervisor
Corden Pharma - A Full-Service CDMO · Boulder, CO · 1 mo ago
Quality AssuranceFull-time
About the role
The Supervisor, Supplier Quality Management oversees and executes the Supplier Quality Management (SQM) Program to ensure suppliers, materials, and service providers meet applicable quality and regulatory requirements. This role provides direct leadership to Supplier Quality personnel and supports supplier qualification, performance monitoring, material review activities, investigations, and risk-based supplier lifecycle management.
Responsibilities
- Supervises daily SQM operations including workload coordination, prioritization, escalation management, and execution of supplier quality activities
- Directs Supplier Quality personnel, including support of onboarding, training, and qualification activities
- Oversees supplier qualification, requalification, and supplier lifecycle management activities in accordance with site procedures, regulatory expectations, and risk-based principles
- Maintains the Approved Supplier List (ASL), including supplier approval status, periodic reviews, and supplier performance monitoring activities
- Performs and/or approves supplier qualification assessments using supplier questionnaires, quality agreements, audits, technical documentation, risk assessments, and supplier performance data
- Schedules and coordinates supplier audits, including audit scheduling, audit response coordination, effectiveness follow-up, and supplier remediation activities
- Collaborates cross-functionally with Supply Chain, Manufacturing, Warehouse, QC, Process Engineering, and Project Management to support compliant and reliable material supply
- Establishes, maintains, and evaluates compliance to Quality Agreements with Material Suppliers and Service Providers
- Communicates/escalates quality risks to management and partners with customers across site, key stakeholders, and management
- Maintains supplier quality metrics and KPIs to identify trends, risks, and opportunities for continuous improvement and site QMRs
- Supports supplier-related investigations, supplier corrective actions (SCARs), material review board (MRB) activities, deviations, complaints, and discrepancy investigations
- Supports supplier change management activities, including assessment of supplier-initiated changes and evaluation of potential quality, regulatory, and operational impacts
- Assists with development, implementation, and continuous improvement of supplier quality procedures, processes, templates, and training materials
- Escalates significant supplier quality risks, compliance concerns, or supply continuity issues to Quality Management, as appropriate
- Promotes effective communication, issue resolution, and continuous improvement initiatives with internal stakeholders and external suppliers
- Manages daily activities of Supplier Quality personnel including assignment coordination, workload balancing, prioritization, and escalation management to support departmental and site objectives
- Supports onboarding and training of new employees, including development and maintenance of training materials, procedures, templates, and work practices related to Supplier Quality Management activities
- Maintains supplier quality records, quality systems, and electronic documentation systems in accordance with applicable procedures and data integrity expectations
- Participates in departmental initiatives, quality improvement activities, and site compliance programs to support overall business and quality objectives
Qualifications
- Bachelor's Degree (BS) with 6 years of related experience and/or training; or equivalent combination of education and experience, including experience in a Manufacturing Environment
- Previous experience leading teams or coordinating supplier quality activities
- Experience with external Quality Auditing is preferred
- Background working with SAP (or similar ERP System), TrackWise, MasterControl, and Microsoft Office Suite
- Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions
- 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, 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