Senior Director, Quality Compliance & Regulatory Strategy

gobravvo; Greenville (SC); On-site; USD 180,000 - 260,000; Full time

Job summary

gobravvo seeks a Director/Senior Director of Quality Compliance to lead governance, audit, inspection, escalation and risk management across the organization. You will maintain cGMP compliance while shaping processes and systems to meet global quality standards and regulatory expectations.

The role requires directing not only internal audits and health authority interactions, but also DEA compliance and Notified Body assessments.

Qualifications

• Bachelor’s degree in a scientific or related discipline.
• Minimum 15 years of experience in quality assurance, quality control, or risk management at senior leadership level.
• Deep knowledge of GMP, regulatory requirements and quality management systems.
• Proven leadership in managing audits (FDA/Notified Bodies) and inspections.
• Exceptional communication and stakeholder management skills.

Responsibilities

• Develop and implement a global Quality Compliance strategy.
• Lead internal and external audits and inspection readiness programs.
• Oversee DEA compliance, post-market surveillance, and CAPA processes.
• Escalate quality events to management and drive corrective actions.
• Collaborate with cross-functional teams to improve quality systems.
• Provide training and guidance on regulatory changes and best practices.

Skills

Quality leadership

Auditing

Regulatory knowledge

Risk management

Cross-functional collaboration

Education

Bachelor's degree in Pharmacy, Chemistry, Biology, Chemical Engineering, or related

Tools

Quality management software

Microsoft Office

Job description

gobravvo seeks a Director/Senior Director of Quality Compliance to lead governance, audit, inspection, escalation and risk management across the organization. You will maintain cGMP compliance while shaping processes and systems to meet global quality standards and regulatory expectations.

The role requires directing not only internal audits and health authority interactions, but also DEA compliance and Notified Body assessments.