SK pharmteco · 5 hours ago
Supplier Quality Mgt Specialist II
Rancho Cordova, CA
Full-time
Onsite
Senior Level
5+ years expSK pharmteco is focused on ensuring supplier compliance with regulatory standards. The Supplier Quality Management Specialist will conduct audits, manage supplier qualifications, and collaborate with various teams to ensure adherence to quality systems and regulatory guidelines.
ChemicalChemical EngineeringDeveloper APIsManufacturing
Responsibilities
Assist in and support audits to assess supplier and service provider compliance with applicable cGMPs, SOPs, and regulatory requirements (FDA, ICH, ISO)
Draft, review, negotiate, and maintain Quality Technical Agreements (QTAs) with suppliers and service providers
Manage Supplier Change Notifications (SCNs), including performing impact assessments and coordinating actions with internal stakeholders
Lead and support deviation investigations, Root Cause Analysis (RCA), Corrective and Preventive Actions (CAPA), and Supplier Corrective Action Requests (SCARs)
Track, trend, and report supplier and service provider quality performance metrics (KPIs)
Create, review, and maintain cGMP-related documentation, specifications, and quality records
Conduct quality risk assessments for new and existing suppliers, materials, and services
Assess adherence to current Good Manufacturing Practices (cGMP), company policies and procedures, and applicable regulatory guidelines (FDA, EMA, ICH)
Collaborate cross-functionally with Regulatory Affairs, Quality Assurance, Quality Control, R&D, Manufacturing, and external partners, including supporting regulatory inspections
Participate as a team member on cross-functional initiatives and continuous improvement projects
As a member of the External Quality team, additional responsibilities related to Quality Audit Management may apply
May perform other duties as assigned
Qualification
Required
Bachelor's degree in Life or Physical Sciences, Engineering, or related field
Significant (5+ years) experience in pharma/biotech, SQM, supplier auditing, GMP environments, and managing regulated materials
Strong analytical, problem-solving, communication, negotiation, and project management skills
Ability to work in a face paced, team-oriented environment
Ability to act with a sense of urgency, while maintaining accuracy and data integrity
Working knowledge of FDA 21 CFR Parts 210/211, ICH Q7, ISO standards (e.g., ISO 9001)
Experience in Quality Management Systems (QMS), ERPs (e.g., TrackWise, MasterControl), and RCA tools (5 Whys, Fishbone)
Preferred
ASQ CQE, ASQ CQA, Six Sigma certifications are a plus
Company
SK pharmteco
SK Pharmteco manufactures APIs, intermediates, analytical services, viral vectors for therapies, and registered starting materials.
1001-5000 employees
Funding
Current Stage
Late StageLeadership Team
Joerg Ahlgrimm
Chief Executive Officer
Recent News
Precedence Research
2025-12-01
2025-11-29
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