Senior Validation Leader in cGMP Compliance & Strategy

Guerbet; Raleigh (NC); On-site; USD 90,000 - 130,000; Full time

Benefits offered by this job

Competitive salary

Personal development opportunities

Job summary

A pharmaceutical company in Raleigh, North Carolina, is seeking a Validation Lead to oversee the Validation Team and ensure compliance with regulatory standards. Responsibilities include managing validation activities for capital projects, leading the internal validation staff, and ensuring adherence to cGMP and FDA regulations. The ideal candidate will have significant validation experience in pharmaceuticals and strong leadership skills to drive operational excellence. This role offers opportunities for continuous development and contribution to innovative solutions to enhance patient care.

Qualifications

• 10 years of validation experience in a pharmaceutical environment.
• 8 years supervisory experience.
• Knowledge of cGMP, FDA, ICH, EMEA regulations.

Responsibilities

• Lead the Validation Team to ensure regulatory compliance.
• Manage validation activities for large scope capital projects.
• Provide leadership on internal and external validation staff.

Skills

Leadership skills

Validation life cycle knowledge

Risk assessment skills

Regulatory compliance knowledge

Communication skills

Education

10 years of validation experience in a pharmaceutical environment

8 years supervisory experience

Tools

Six Sigma

Lean methodologies

Job description

A pharmaceutical company in Raleigh, North Carolina, is seeking a Validation Lead to oversee the Validation Team and ensure compliance with regulatory standards. Responsibilities include managing validation activities for capital projects, leading the internal validation staff, and ensuring adherence to cGMP and FDA regulations. The ideal candidate will have significant validation experience in pharmaceuticals and strong leadership skills to drive operational excellence. This role offers opportunities for continuous development and contribution to innovative solutions to enhance patient care.