Senior Director, GMP Quality Assurance

This is a fully remote position, open to applicants in United States.

📋 Description

• Spearhead the development, implementation, governance, and ongoing enhancement of the Company's pharmaceutical quality system.

• Provide independent Quality oversight for manufacturing, testing, packaging, labeling, storage, and distribution activities carried out by external partners.

• Act as the final Quality authority for batch disposition and release within assigned responsibilities.

• Review and authorize batch records, analytical outcomes, deviations, investigations, change controls, CAPAs, specifications, validation documentation, and other product-quality records.

• Supervise process and analytical modifications, technology transfers, validation initiatives, new product launches, product acquisitions, and post-approval changes.

• Establish and uphold risk-based qualification, auditing, monitoring, and requalification programs for GxP suppliers.

• Formulate quality agreements and governance processes with external partners.

• Track quality performance through metrics, management reviews, trend analysis, and partner governance.

• Lead regulatory inspection readiness and serve as the primary Quality representative during inspections and interactions with health authorities.

• Oversee responses to inspections and commitments for remediation.

• Ensure oversight of data integrity, electronic records, computerized systems, and documentation practices.

• Lead or assist in addressing critical quality events, investigations, complaints, recalls, market actions, and regulatory notifications.

• Provide Quality expertise for business-development due diligence, licensing, acquisitions, investigator-initiated studies, and promotional review.

• Develop and manage the Quality Affairs budget, organizational capabilities, resource plans, and external support.

• Build and lead a high-performing Quality organization while promoting a culture of quality, accountability, compliance, transparency, and continuous improvement.

⛳️ Requirements

• Bachelor’s degree in chemical engineering, pharmaceutical sciences, chemistry, biochemistry, biology, or a related scientific or engineering field.

• Advanced degree preferred.

• Minimum of 15 years of progressively responsible Quality experience within the pharmaceutical or biotechnology sector.

• Significant leadership experience with commercial products.

• Proven experience leading Quality in a fully or substantially outsourced operating model.

• Experience managing CDMOs, contract laboratories, packaging and labeling providers, distributors, and other GxP suppliers.

• Comprehensive experience across various product modalities and manufacturing platforms.

• Extensive knowledge of batch disposition, pharmaceutical quality systems, supplier quality, investigations, change control, CAPA, validation oversight, product complaints, and inspection readiness.

• Strong understanding of global GMP and GDP requirements, including 21 CFR Parts 210 and 211, relevant EU regulations and GMP guidance, ICH guidelines, and applicable FDA and EMA expectations.

• Experience in direct interactions with regulatory authorities and leading regulatory inspections, responses, remediation activities, and compliance commitments.

• Ability to make independent, risk-based product-quality and compliance decisions informed by scientific and regulatory judgment.

• Experience in leading managers and professional staff, establishing Quality governance across cross-functional and external partner organizations.

• Strong executive presence with the capability to clearly communicate complex quality risks, recommendations, and decisions.

• Excellent leadership, negotiation, organizational, analytical, and problem-solving abilities.

• Capacity to manage multiple priorities in a dynamic environment.

🏝️ Benefits

• Discretionary annual bonus may be available based on individual and Company performance.

• Equal opportunity employer.

• Background screening required as a condition of employment.