Associate Director – External Quality Control

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

📋 Description

• Act as the principal QC Subject Matter Expert (SME) for analytical methodologies, specifications, and QC data that support external manufacturing.

• Specify QC technical requirements and performance standards for external laboratories.

• Conduct risk-based evaluations of QC capabilities across Contract Manufacturing Organizations (CMOs), Contract Testing Organizations (CTOs), and Contract Development and Manufacturing Organizations (CDMOs), focusing on analytical technologies, method lifecycle maturity, and data integrity practices.

• Ensure that external QC activities meet regulatory requirements and adhere to internal quality standards.

• Oversee Quality management for the analytical method lifecycle, including validation, verification, transfer, and ongoing management at external sites.

• Lead or manage method transfer strategies and readiness for execution, ensuring robustness and comparability across different sites.

• Collaborate with Analytical Sciences (e.g., APTL/APL) to facilitate method lifecycle management, continuous enhancement, and issue resolution.

• Guarantee consistency in analytical methods and documentation across external sites, aligning with internal and regulatory standards.

• Develop and sustain QC performance monitoring systems across external laboratories.

• Direct statistical trending and analysis of QC metrics and signals, such as system suitability performance, invalid assay rates, and method variability and drift.

• Draft and review QC sections of regulatory submissions (e.g., BLA, MAA, IND), ensuring scientific integrity and uniformity.

• Assist with health authority inspections and responses, including the defense of analytical methods and data.

• Ensure that external QC practices comply with global regulatory expectations (FDA, EMA, ICH).

• Represent External QC in cross-functional governance forums, including QC Network Strategy (QCNS) and Analytical/Quality Partner Teams (APT/QPT).

• Contribute to external laboratory selection, make vs. buy decisions, and analytical control strategies.

• Provide technical SME leadership for QC-related investigations, including Out of Specification (OOS), Out of Trend (OOT), and method performance challenges.

• Lead or assist in root cause analysis and formulate technically sound corrective measures.

• Collaborate with internal QC and Analytical Sciences teams to ensure proper qualification, lifecycle management, and utilization of reference standards and critical reagents at external laboratories.

• Offer QC SME support during audits and inspections, ensuring that technical practices align with Quality Management System (QMS) requirements.

• Proven ability to lead cross-functional teams and influence technical decisions without direct authority.

⛳️ Requirements

• PhD with 4+ years, MS with 6+ years, or BS with 8–10+ years in analytical sciences, Quality Control, or a related field.

• Extensive experience in cGMP-regulated biopharmaceutical settings.

• Proven expertise in analytical method lifecycle management, validation, comparability, regulatory submissions (BLA/MAA/IND), and health authority interactions.

• Strong grasp of global regulatory requirements, including FDA, EMA, ICH, WHO, and expectations for health authority inspections.

• Demonstrated knowledge of Data Integrity principles (ALCOA+).

• Experience supporting regulatory inspections, audits, and interactions with health authorities.

• In-depth expertise in analytical techniques used for biologics and small molecules (e.g., chromatography, bioassays).

• Experience in statistical analysis and trending of QC data is preferred.

• Familiarity with external manufacturing/testing networks (CMOs/CDMOs/CTOs) is highly preferred.

🏝️ Benefits

• Health insurance

• Retirement plans

• Paid time off