Validation & Quality Strategy Lead

Sovereign Pharmaceuticals; Fort Worth (TX); On-site; USD 120,000 - 180,000; Full time

Job summary

Sovereign Pharmaceuticals seeks a Manager to provide strategic leadership for quality and validation operations (CQV). The role drives compliance excellence, regulatory alignment, and continuous improvement across the pharmaceutical manufacturing environment.

The Manager will mentor teams, shape validation strategies, and collaborate cross-functionally to enhance efficiency and quality. Strong experience with FDA/EMA expectations and cGMP is required.

Qualifications

• Bachelor's Degree in Chemistry or Engineering with 7+ years in validation, qualification, and commissioning in pharma.

Responsibilities

• Develop and drive the quality operational strategy for site compliance in CQV.
• Lead qualification, validation, and commissioning activities.
• Draft and review validation documentation, protocols, and reports.
• Ensure compliance with cGMP, GAMP, and SOPs.
• Coordinate product technology transfers and risk assessments.
• Mentor and develop quality talent within the unit.

Skills

Leadership

Project management

Regulatory knowledge

Technical writing

Computers / MS Office

Education

Bachelor's Degree in Chemistry or Engineering

Tools

Microsoft Word

Microsoft Excel

Microsoft PowerPoint

Job description

Sovereign Pharmaceuticals seeks a Manager to provide strategic leadership for quality and validation operations (CQV). The role drives compliance excellence, regulatory alignment, and continuous improvement across the pharmaceutical manufacturing environment.

The Manager will mentor teams, shape validation strategies, and collaborate cross-functionally to enhance efficiency and quality. Strong experience with FDA/EMA expectations and cGMP is required.