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Associate Director – External Quality Control
BioMarin Pharmaceutical Inc.Associate Director, External Quality Control ensuring QC compliance and oversight across external organizations in biopharmaceuticals. Engaging in risk assessment, method lifecycle management, and regulatory submissions.
About the role
Key responsibilities & impact- 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.
Requirements
What you’ll need- 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
Comp & perks- Health insurance
- Retirement plans
- Paid time off
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
Analytical Method ValidationMethod Transfer StrategiesStatistical TrendingChromatography TechniquesBioassays
Soft Skills
Cross-Functional Team LeadershipInfluencing Technical Decisions