Full-Time QA Supplier Senior Manager

Quality Supplier Senior Manager

The Quality Supplier manager oversees the quality oversight of external suppliers for manufacturing activities.

Key Responsibilities:

• Single point of contact for all quality-related activities at the External Supplier
• Ensuring compliance with Sobi Quality system, QTA, and cGMP regulations for handling, manufacturing, and distribution.
• Leading External supplier Qualification
• Establishing and maintaining Quality Technical Agreements (QTAs)
• Implementing and maintaining Quality Risk Assessments and KPIs
• Defining and monitoring Remediation plans
• Driving improvement opportunities for product and process quality
• Requesting, reviewing GMP and GDP documentation
• Ensuring External supplier product reviews and data (APQR/PQRs, stability reports) are provided as specified
• Assessing product and process performance
• Managing/approving quality issues (deviations, CAPA, and complaints)
• Managing Change requests from External Supplier or Sobi
• Ensuring Quality Audits of the CMO
• Defining Quality transformation initiatives and aligning with stakeholders
• Acting as Quality representative in projects
• Assessing and ensuring External Supplier readiness for Health Authorities inspections
• Supporting inspections/audits
• Informing Sobi management and cross-functional teams of critical issues
• Ensuring good collaboration within the product team

Qualifications:

• Bachelor's degree in life sciences or related field
• 10+ years of experience in pharmaceutical/biotech
• Extensive QA, production, or GMP/GDP experience
• Strong knowledge of US & European regulations, Annex 13 (and preferably other regions like APAC, LATAM)
• Risk assessment & management skills
• Fluent English (written & spoken)
• Ability to travel approximately 25% of the time

Personal Attributes:

• Solid understanding of GMP, GDP, and GCP
• Adaptability in a dynamic global environment
• Diplomatic and tactful communication
• Strong critical reasoning, risk analysis, and problem-solving skills
• Interpersonal and leadership skills

Compensation:

Base salary: $130,000-$170,000 annually. Benefits include 401k match, incentives, medical, dental, vision, STD/LTD, and life insurance.

What is the last date for applying to the job?

Which countries are accepted for this remote job?