Associate Director, External Quality Control
This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for an Associate Director, External Quality Control based in United States.
This is a senior technical leadership role responsible for providing strategic and scientific oversight of external Quality Control activities across a global network of contract manufacturing and testing organizations.
You will act as the QC subject matter expert, ensuring analytical methods, specifications, and data integrity standards are consistently applied across external partners.
The role has a strong focus on method lifecycle management, including validation, transfer, and continuous improvement across CMOs, CDMOs, and CTOs.
You will drive data-driven oversight using statistical trending and QC performance monitoring to identify risks and improve quality systems.
This position requires close collaboration with analytical sciences, regulatory affairs, and global quality teams to ensure compliance and inspection readiness.
You will also support regulatory submissions and health authority inspections, contributing directly to global product quality and patient safety.
The environment is highly regulated, cross-functional, and scientifically rigorous, with global impact across the external manufacturing network.
This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for an Associate Director, External Quality Control based in United States.
This is a senior technical leadership role responsible for providing strategic and scientific oversight of external Quality Control activities across a global network of contract manufacturing and testing organizations.
You will act as the QC subject matter expert, ensuring analytical methods, specifications, and data integrity standards are consistently applied across external partners.
The role has a strong focus on method lifecycle management, including validation, transfer, and continuous improvement across CMOs, CDMOs, and CTOs.
You will drive data-driven oversight using statistical trending and QC performance monitoring to identify risks and improve quality systems.
This position requires close collaboration with analytical sciences, regulatory affairs, and global quality teams to ensure compliance and inspection readiness.
You will also support regulatory submissions and health authority inspections, contributing directly to global product quality and patient safety.
The environment is highly regulated, cross-functional, and scientifically rigorous, with global impact across the external manufacturing network.
Accountabilities:
- Provide scientific and technical leadership as the QC subject matter expert for analytical methods, specifications, and external laboratory testing activities.
- Define QC performance standards, technical requirements, and quality expectations for CMOs, CDMOs, and CTOs.
- Oversee analytical method lifecycle activities including validation, transfer, verification, and continuous improvement across external partners.
- Conduct risk-based assessments of external QC capabilities, including data integrity, method robustness, and laboratory performance.
- Establish and maintain QC monitoring frameworks, including statistical trending of key performance indicators such as assay variability and system suitability.
- Support regulatory submissions and inspections (BLA, MAA, IND), ensuring accuracy, scientific integrity, and compliance with global requirements.
- Lead or support investigations of QC issues, including OOS/OOT events, and drive root cause analysis and corrective actions.
- Advanced degree in Chemistry, Biochemistry, Pharmaceutical Sciences, or related field (PhD preferred, or MS/BS with equivalent experience).
- 8+ years of experience in Quality Control, Analytical Sciences, or related roles within cGMP-regulated biopharmaceutical environments.
- Strong expertise in analytical method lifecycle management, including validation, transfer, and regulatory documentation.
- Deep knowledge of global regulatory frameworks (FDA, EMA, ICH) and data integrity principles (ALCOA+).
- Experience working with biologics or small molecule analytical techniques such as chromatography and bioassays.
- Proven experience supporting regulatory inspections, audits, and health authority interactions.
- Strong analytical, problem-solving, and statistical trending skills for QC data analysis.
- Experience working with external manufacturing or testing networks (CMOs, CDMOs, CTOs) strongly preferred.
- Competitive executive-level compensation aligned with experience.
- Comprehensive health, dental, and vision insurance coverage.
- Retirement savings plan options with employer contributions.
- Paid time off, holidays, and flexible work arrangements.
- Remote-first role with periodic travel requirements.
- Exposure to global regulatory and scientific leadership responsibilities.
- Opportunity to work on high-impact therapies in rare disease and biologics.