Senior Validation Manager: GMP Compliance & QA

Regulatory Jobs; Allentown (Lehigh County); On-site; USD 120,000 - 160,000; Full time

Benefits offered by this job

Healthcare

Annual incentive plan

Bonus scheme

Career development opportunities

Job summary

Thermo Fisher Scientific in Allentown, PA is seeking a Senior Validation Manager to lead validation activities ensuring product quality and regulatory compliance across equipment, utilities, facilities, computer systems and manufacturing processes.

You will develop validation strategy, manage a team, support cGMP requirements and regulatory inspections, and collaborate across functions to enable successful product introductions and technology transfers.

Qualifications

• Advanced degree plus 4 years of validation in pharma/biotech manufacturing or related regulated industry.
• Bachelor's degree plus 6 years of validation experience in pharma/biotech manufacturing or related field.
• 3+ years of people management or team leadership experience.
• Experience with equipment, process, cleaning, computer system, and utility validation.
• Temperature mapping experience preferred.
• Data integrity evaluation and ALCOA++ principles knowledge.
• Experience with regulatory inspections and customer audits.
• Experience with validation master planning and change control systems.

Responsibilities

• Working across functions, ensure validation activities align with cGMP requirements while supporting new product introductions and technology transfers.
• Maintain the validated state of systems that help produce therapeutics.

Skills

Risk assessment

Statistical analysis

cGMP regulations

Documentation

Leadership

Cross-functional collaboration

Education

Advanced degree +4 years in pharma/biotech validation

Bachelor's degree +6 years in validation

Tools

Quality systems

Job description

Thermo Fisher Scientific in Allentown, PA is seeking a Senior Validation Manager to lead validation activities ensuring product quality and regulatory compliance across equipment, utilities, facilities, computer systems and manufacturing processes.

You will develop validation strategy, manage a team, support cGMP requirements and regulatory inspections, and collaborate across functions to enable successful product introductions and technology transfers.