Associate Director, Early Development Quality Lead, R&D QA

Alnylam Switzerland GmbH; United States; Hybrid; USD 164,500 - 222,500; Full time

Benefits offered by this job

Comprehensive medical, dental, and vision coverage

401(k) with generous company match

Paid time off and wellness days

Job summary

Alnylam Switzerland GmbH is seeking an Early Development Quality Lead responsible for strategic quality oversight of nonclinical studies and collaboration on quality-related activities within Alnylam. The role can be hybrid, onsite, or remote within the U.S.

The ideal candidate will have extensive experience in bioanalytical and toxicology, familiarizing with GLP, GCP regulations, and modern biomarker assays. Suitable applicants will also be part of a supportive work environment that offers competitive compensation and extensive benefits.

Qualifications

• 8+ years of experience in bioanalytical and toxicology subjects.
• Experience with GLP and GCP regulations.
• Familiarity with modern biomarker-based assay techniques.

Responsibilities

• Provide strategic quality oversight for nonclinical studies.
• Collaborate with teams to ensure quality in lab management.
• Implement robust vendor oversight and audit programs.

Skills

Bioanalytical expertise

Toxicology knowledge

Quality assurance

Assay development

Risk-based thinking

Education

Master’s degree in life sciences or related discipline

Tools

PCR

ELISA

FISH

Job description

Overview

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 Alnylam colleagues within Early Development, Bioanalytical, Nonclinical Writing, Research, and Clinical Research to provide quality support and oversight and ensure the identification, mitigation, and escalation of emerging quality risks and concerns.

The position is located within the U.S. and can be hybrid, onsite, or remote.

Key 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 a 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.
• Serve as the quality escalation point for CRO/vendor quality issues and lead quality governance activities to ensure appropriate identification, issue escalation, and mitigation of emerging compliance risks.
• Provide 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.
• Partner 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) or equivalent qualification or work experience. Master’s degree in a science, technology or industry related discipline preferred.
• Minimum of 8 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 familiarity with modern 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.

Compensation and Benefits

U.S. Pay Range: $164,500.00 – $222,500.00

This role is eligible for an annual short‑term incentive award (e.g., bonus or sales incentive) and an annual long‑term incentive award (e.g., equity).

Benefits include comprehensive medical, dental, and vision coverage; life and disability insurance; lifestyle reimbursement program; flexible spending and health savings accounts; 401(k) with generous company match; paid time off, wellness days, holidays, and company‑wide recharge breaks; and family resources and leave.

EEO Statement

At Alnylam, we commit to an inclusive recruitment process and equal employment opportunity. Qualified applicants will receive consideration for employment without regard to their sex, gender or gender identity, sexual orientation, race, color, ethnicity, national origin, ancestry, citizenship, religion, creed, physical or mental disability, pregnancy status or related conditions, genetic information, veteran or military status, marital or familial status, political affiliation, age, or any other factor protected by federal, state, or local law. Alnylam is an E‑Verify Employer.