Pharma Quality & Validation Lead

Phlow Corp; Petersburg (VA); On-site; USD 60,000 - 70,000; Full time

Benefits offered by this job

Medical insurance

Retirement plans

Paid time off

Education benefits

Stock options

Job summary

Phlow Corp in Virginia seeks a Pharmaceutical Quality Specialist to oversee documentation and processes essential for qualification activities in pharmaceutical manufacturing, ensuring compliance with FDA, EMA, and cGMP standards and protecting product integrity and patient safety.

The role covers quality operations, validation management, and process improvements, with responsibilities including authoring and reviewing procedures, handling audits, and leading regulatory-inspection readiness.

Qualifications

• Minimum of 5 years of experience in a pharmaceutical or biotechnology environment.
• Strong knowledge of FDA, ICH and other global regulatory requirements, including cGMP and GAMP5.
• Hands-on experience with qualification and validation of processes, facilities, equipment, utilities, and computerized systems.
• Excellent communication, problem-solving, and organizational skills.
• Proficiency in QMS and ERP software and documentation management systems is a plus.

Responsibilities

• Author, review and approve procedures, reports, batch records and other necessary documents to support ongoing manufacturing processes that follow regulatory standards.
• Responsible for Quality Operations oversight including real-time batch record review, deviation responses and CAPA implementation.
• Provide Quality review and support for calibration and maintenance programs and ensure they are run following GMP regulation.
• Participate in or lead quality risk analysis and regulatory inspections support.
• Lead quality-based training of operations team members and ensure documentation is compliant.

Skills

Regulatory compliance

Quality systems

Documentation management

Communication

Problem solving

Organizational skills

Education

Bachelor’s degree in Science/Engineering/Pharmacy

Tools

QMS software

ERP software

Job description

Phlow Corp in Virginia seeks a Pharmaceutical Quality Specialist to oversee documentation and processes essential for qualification activities in pharmaceutical manufacturing, ensuring compliance with FDA, EMA, and cGMP standards and protecting product integrity and patient safety.

The role covers quality operations, validation management, and process improvements, with responsibilities including authoring and reviewing procedures, handling audits, and leading regulatory-inspection readiness.