Associate Director Quality Assurance (GLP)

Role Summary

The Early Development Quality Lead is responsible for the strategic quality oversight of internal and external (outsourced) activities in support of nonclinical studies (GLP and non-GLP), IND enabling work, and the utilization of biomarkers within development programs (preclinical and clinical).

This role partners with colleagues across Early Development, Bioanalytical, Nonclinical Writing, Research, and Clinical Research to provide quality support, ensure timely identification, mitigation, and escalation of emerging quality risks and concerns.

This position will be located in the US and can be hybrid, onsite, or remote.

Responsibilities

• Sets the strategic quality oversight direction for internal and outsourced laboratory activities supporting nonclinical studies (GLP and non-GLP), including toxicology, bioanalytical and biomarker data that supports IND submissions.
• Establish and maintain quality oversight of external laboratories including Test Facilities, Test Sites, and Clinical Laboratories by implementing governance framework and ongoing performance monitoring.
• Collaborate with nonclinical and clinical teams (in partnership with GCP Program Leads) to integrate quality considerations into the selection, contracting, and management of external labs.
• Ensure internally developed and outsourced biomarker development / analytical work complies with internal quality system requirements and external regulatory standards including GCP, GLP, ICH, and OECD.
• Refine and continuously implement robust, risk-based vendor oversight and audit program globally for nonclinical work. Lead the risk assessment and audit strategy for external laboratories and ensure planned audits are executed in alignment with the GCP/GLP yearly audit program.
• Support the management of nonclinical and clinical lab focused quality issues arising from outsourced activities, including quality events, significant quality issues, and CAPA oversight.
• Serves as the Quality escalation point for CRO/vendor quality issues and leads quality governance activities to ensure appropriate identification, issue escalation and the mitigation of emerging compliance risks.
• Provides quality strategic direction for the functional evaluation of CRO or key vendor processes or process improvement opportunities.
• Drive the strategic identification and implementation of process improvement opportunities within Alnylam’s QMS, in support of early development and research.
• Partners with Legal/Procurement for appropriate oversight language in contractual agreements and ensure compliance.

Qualifications

• Educated preferably in life sciences (technology, biological science, pharmacy or other health related discipline preferred) or equivalent qualification or work experience. Master’s degree in a science, technology or industry related discipline, preferred.
• Minimum of 10 years of relevant experience, inclusive of bioanalytical and toxicology subject matter, as it relates to GLPs, GCPs and GCLPs.
• Direct experience in the field of assay development and validation and familiar with biomarker-based assays (e.g., PCR, ELISA, FISH) is preferred.
• Prior experience in risk-based thinking, quality assurance, auditing, managing quality issues/escalations, or other relevant QMS elements.
• Prior expertise in global GLP, GCP, GCLP regulations and guidance across regulatory bodies such as FDA, PMDA, European Union, MHRA, etc.