Remote Senior Director, GMP Quality Assurance

Jobgether SRL; United States; Remote; USD 250,000 - 320,000; Full time

Benefits offered by this job

Remote work (US)

Job summary

Jobgether SRL seeks a Senior Director of GMP Quality Assurance to lead quality strategy for a growing biopharma portfolio in the United States. This executive role oversees outsourced manufacturing partners, labs, and other GxP service providers, ensuring GMP compliance and product quality across lifecycle.

You will guide product disposition, quality system governance, inspection readiness, and risk management while collaborating with executive leadership and external partners to drive

Qualifications

• Bachelor's degree in chemical engineering, pharmaceutical sciences, chemistry, biochemistry, biology, or related discipline; advanced degree preferred.
• At least 15 years of progressively responsible Quality experience in pharma/biotech, with leadership for commercial products.
• Experience leading Quality in outsourced models, including CDMOs, labs, packaging providers, and distributors.
• Broad technical expertise in batch disposition, QMS, supplier quality, investigations, change control, CAPAs, validation readiness.

Responsibilities

• Lead pharmaceutical quality systems development, governance, and continuous improvement across outsourced partners.
• Provide independent quality oversight of manufacturing, testing, packaging, labeling, storage, and distribution by external partners.
• Act as final quality authority for batch disposition and release with market-specific compliance.
• Review and approve quality documentation, investigations, CAPAs, and validations.
• Oversee lifecycle activities: transfers, validation, new products, acquisitions, and post-approval changes.
• Establish risk-based qualification, auditing, monitoring, and requalification for CDMOs and GxP suppliers.
• Define quality agreements, escalation paths, and performance expectations with external partners.
• Develop quality metrics, trend analyses, and escalate significant risks and adverse trends.
• Lead inspection readiness and regulatory interactions; manage responses and remediation commitments.
• Protect data integrity across internal operations and external GxP network.
• Manage significant quality events and regulatory notifications; support due diligence and licensing.

Skills

Quality leadership

Regulatory knowledge

Executive communication

Decision making

Risk management

Data integrity

Partner governance

GxP experience

Education

Bachelor's degree

Advanced degree

Tools

CDMOs oversight

Job description

Jobgether SRL seeks a Senior Director of GMP Quality Assurance to lead quality strategy for a growing biopharma portfolio in the United States. This executive role oversees outsourced manufacturing partners, labs, and other GxP service providers, ensuring GMP compliance and product quality across lifecycle.

You will guide product disposition, quality system governance, inspection readiness, and risk management while collaborating with executive leadership and external partners to drive