Biopharma Quality Operations Leader

Ferring Pharmaceuticals Inc.; Minneapolis (MN); On-site; USD 121,000 - 173,000; Full time

Benefits offered by this job

Comprehensive healthcare

401(k) with company match

Paid parental leave

Job summary

Ferring Pharmaceuticals Inc. in Roseville, Minnesota is seeking a Sr. Quality Operations Manager to establish and oversee Quality Operations for Manufacturing, Technical Services, and R&D support.

You will lead a team to ensure on-time batch release, comply with cGMP, and manage Donor/Material Hold programs for both clinical and commercial products. The role partners with cross-functional teams across US operations and global sites, applying deep regulatory knowledge and continuous improvement

Qualifications

• Bachelor's degree in a scientific field; advanced degree preferred.
• Seven+ years of management experience in FDA-regulated manufacturing.
• Seven+ years in a pharmaceutical/biopharmaceutical environment.
• Knowledge of quality regulations and current industry practices.
• In-depth knowledge of 21 CFR 210 & 211 GMP regulations.
• Preferred knowledge of 21 CFR 600 & 610 GMP regulations.
• Preferred knowledge of 21 CFR 820 and ISO 13485.

Responsibilities

• Lead and manage Quality Operations functions across manufacturing, technical services, donor management, supply chain, and R&D.
• Oversee batch records issuance/review, COA creation, and disposition processes.
• Maintain Donor and Material Hold program and lot release schedule.
• Perform investigations into deviations and customer complaints.
• Develop metrics and KPI reporting; support continuous improvement.
• Provide regulatory and quality system support; participate in cross-functional projects.
• Hire, manage, and develop direct reports.
• Assist with label approval and product disposition during shipping.

Skills

People management

Leadership

Quality operations

GxP experience

Regulatory knowledge

Education

Bachelor's degree in a scientific field

Advanced degree preferred

Job description

Ferring Pharmaceuticals Inc. in Roseville, Minnesota is seeking a Sr. Quality Operations Manager to establish and oversee Quality Operations for Manufacturing, Technical Services, and R&D support.

You will lead a team to ensure on-time batch release, comply with cGMP, and manage Donor/Material Hold programs for both clinical and commercial products. The role partners with cross-functional teams across US operations and global sites, applying deep regulatory knowledge and continuous improvement