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Associate Director – External Quality Control
Location
United States
Posted
1 day ago
Salary
0
Seniority
Senior
Job Description
Associate Director – External Quality Control
BioMarin Pharmaceutical Inc.
• Serve as the authoritative QC SME for analytical methods, specifications, and QC data supporting external manufacturing. • Define QC technical requirements and performance expectations for external laboratories. • Lead risk-based assessments of QC capabilities across CMOs/CTOs/CDMOs, including analytical technologies, method lifecycle maturity, and data integrity practices. • Ensure external QC activities are aligned with regulatory expectations and internal quality standards. • Provide Quality oversight for analytical method lifecycle activities including validation, verification, transfer, and lifecycle management at external sites. • Lead or oversee method transfer strategies and execution readiness, ensuring robustness and comparability across sites. • Partner with Analytical Sciences (e.g., APTL/APL) to support method lifecycle management, continuous improvement, and issue resolution. • Ensure consistency of analytical methods and documentation across external sites in alignment with internal and regulatory standards. • Establish and maintain QC performance monitoring frameworks across external laboratories. • Lead statistical trending and analysis of QC metrics and signals, including, system suitability performance, invalid assay rates, method variability and drift. • Author and review QC sections of regulatory submissions (e.g., BLA, MAA, IND), ensuring scientific integrity and consistency. • Support health authority inspections and responses, including defense of analytical methods and data. • Ensure alignment of external QC practices with global regulatory expectations (FDA, EMA, ICH). • Represent External QC in cross-functional governance forums, including QC Network Strategy (QCNS), Analytical/Quality Partner Teams (APT/QPT). • Provide input into external laboratory selection, make vs. buy decisions, analytical control strategies. • Provide technical SME leadership for QC-related investigations, including OOS/OOT and method performance issues. • Lead or support root cause analysis and define technically sound corrective actions. • Partner with internal QC and Analytical Sciences teams to ensure appropriate qualification, lifecycle management, and use of reference standards and critical reagents at external laboratories. • Provide QC SME support during audits and inspections, ensuring technical practices are consistent with QMS requirements. • Experience leading cross-functional teams and influencing technical decisions without direct authority.
Job Requirements
- PhD with 4+ years, MS with 6+ years, or BS with 8–10+ years in analytical sciences, Quality Control, or related discipline.
- Significant experience in cGMP-regulated biopharmaceutical environments.
- Demonstrated expertise in analytical method lifecycle management, validation, comparability, regulatory submissions (BLA/MAA/IND), and Health authority interactions.
- Strong understanding of global regulatory requirements including FDA, EMA, ICH, WHO, and Health Authority inspection expectations.
- Demonstrated knowledge of Data Integrity principles (ALCOA+).
- Experience supporting regulatory inspections, audits, and health authority interactions.
- Deep expertise in analytical techniques used for biologics/small molecules (e.g., chromatography, bioassays).
- Experience in statistical analysis and trending of QC data preferred.
- Experience with external manufacturing/testing networks (CMOs/CDMOs/CTOs) strongly preferred.
Benefits
- Health insurance
- Retirement plans
- Paid time off
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