CQV & Validation Strategy Leader

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

Job summary

Sovereign Pharmaceuticals is seeking a Manager to provide strategic leadership for quality and validation operations, covering commissioning, qualification, and validation (CQV). The role ensures regulatory alignment, drives continuous improvement, and mentors teams to raise operation and quality standards.

The ideal candidate has strong knowledge of cGMP/GAMP, proven project management skills, and experience with regulatory interactions.

Qualifications

• Bachelor's degree in a physical or applied scientific discipline with 7+ years in validation/qualification/commissioning in pharma.
• Experience in developing, authoring, and executing validation documentation and reports.
• Ability to facilitate teams and manage projects with timelines and budgets.
• Knowledge of FDA cGMP and GAMP requirements.
• Experience interfacing with FDA/EMA or other regulators.

Responsibilities

• Provide strategic leadership for CQV activities and validation programs.
• Develop and implement quality roadmap ensuring cGMP/GAMP compliance.
• Mentor teams and lead cross-functional validation efforts.
• Oversee creation of validation specs, trace matrices, and validation reports.
• Coordinate product technology transfers and risk assessments.

Skills

Leadership

Project management

Technical writing

Interpersonal communication

Regulatory knowledge

Education

Bachelor's Degree in Chemistry

Bachelor's Degree in Engineering

Tools

Excel

Word

PowerPoint

Job description

Sovereign Pharmaceuticals is seeking a Manager to provide strategic leadership for quality and validation operations, covering commissioning, qualification, and validation (CQV). The role ensures regulatory alignment, drives continuous improvement, and mentors teams to raise operation and quality standards.

The ideal candidate has strong knowledge of cGMP/GAMP, proven project management skills, and experience with regulatory interactions.