Senior Quality Operations Leader - Biopharma

Ferring Pharmaceuticals SA; Minneapolis (MN); On-site; USD 130,000 - 190,000; Full time

Job summary

Ferring Pharmaceuticals SA is seeking a Sr. Quality Operations Manager to establish and maintain Quality Operations systems supporting Manufacturing Operations, Technical Services, and R&D.

You will oversee batch records, COA, and disposition, while guiding donor/material hold programs and maintaining cGMP compliance. You will also drive quality improvements, lead investigations, and provide KPI-based insights to ensure timely product releases for commercial and clinical programs in a fast-paced

Qualifications

• Experience leading Quality Operations within pharmaceutical manufacturing.
• Solid knowledge of GxP and cGMP regulations applicable to biotech/pharma.
• Ability to manage batch records, COA, and disposition activities.

Responsibilities

• Lead the Quality Operations functions to support Manufacturing Operations, Technical Services, Donor Management, Supply Chain and R&D.
• Manage batch record issuance, review, COA creation and product disposition.
• Oversee donor/material hold program and ensure timely review and retrieval of records.
• Coordinate in-process quality reviews and review analytical data and batch records.
• Establish metrics and reporting for KPIs and management reviews.
• Support investigations of deviations, CAPAs and quality issues, driving right-first-time execution.

Skills

Quality Operations

GXP/cGMP

Batch records management

Data analysis & KPI reporting

Education

Bachelor's degree in life sciences or related field

Tools

COA creation & submission processes

Job description

Ferring Pharmaceuticals SA is seeking a Sr. Quality Operations Manager to establish and maintain Quality Operations systems supporting Manufacturing Operations, Technical Services, and R&D.

You will oversee batch records, COA, and disposition, while guiding donor/material hold programs and maintaining cGMP compliance. You will also drive quality improvements, lead investigations, and provide KPI-based insights to ensure timely product releases for commercial and clinical programs in a fast-paced