Pharma Validation & Quality Manager

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 and oversight for quality and validation operations related to commissioning, qualification, and validation (CQV) activities at the Fort Worth site. You will shape validation strategies, mentor teams, and collaborate cross-functionally to enhance operational efficiency and regulatory compliance.

The role requires a Bachelor's in a physical or applied science and at least seven years in validation, qualification, and

Qualifications

• Bachelor-level degree in a physical or applied scientific discipline with 7+ years in validation, qualification, and commissioning in pharma.
• Experience developing, authoring, and executing validation docs, technical protocols, and reports.
• Proven ability to lead teams and manage projects, timelines, and budgets.
• Knowledge of cGMP, GAMP, and FDA/EMEA regulatory expectations.
• Strong communication skills, both written and verbal, with stakeholder influence.

Responsibilities

• Lead quality operations strategy and execution for site quality, qualification, and validation activities (e.g., Process Validation, Equipment and CSV).
• Oversee validation documentation, test protocols, and validation summary reports.
• Drive global quality initiatives and implement a quality roadmap aligned with regulatory demands.
• Mentor and develop the Technical Services Unit team; recruit and retain quality talent.
• Coordinate product technology transfers and risk assessments with internal and external partners.

Skills

Leadership

Regulatory knowledge

Project management

Communication

Analytical thinking

Education

Bachelor's Degree in Chemistry or Engineering

Tools

Microsoft Office

Job description

Sovereign Pharmaceuticals seeks a Manager to provide strategic leadership and oversight for quality and validation operations related to commissioning, qualification, and validation (CQV) activities at the Fort Worth site. You will shape validation strategies, mentor teams, and collaborate cross-functionally to enhance operational efficiency and regulatory compliance.

The role requires a Bachelor's in a physical or applied science and at least seven years in validation, qualification, and