Alnylam Pharmaceuticals · 21 hours ago
Associate Director, Early Development Quality
Cambridge, MA
Full-time
Hybrid
Lead/Staff, Director/Executive
$164K/yr - $222K/yr
10+ years expAlnylam Pharmaceuticals is a leader in RNAi therapeutics, focusing on innovative solutions for rare and common diseases. They are seeking an Associate Director, Early Development Quality to provide strategic quality leadership across nonclinical development programs, ensuring compliance and risk management in laboratory partnerships and regulatory submissions.
BiotechnologyHealth CareMedicalPharmaceuticalTherapeutics
Responsibilities
Sets the strategic quality oversight direction for internal and outsourced laboratory activities supporting nonclinical development (GLP and non-GLP), including toxicology, bioanalytical, and biomarker data supporting IND, CTA, and NDA submissions
Provides upstream scientific and quality risk oversight for nonclinical programs by partnering with Research, Nonclinical Project Teams, Biomarker, Bioanalytical, Regulatory, and Nonclinical Writing functions to evaluate study strategies, contribute to protocol design, and proactively identify risks that could impact data integrity, translational interpretation, or downstream clinical and regulatory outcomes
Acts as a strategic quality partner in biomarker development and evaluation, ensuring fitness for purpose, analytical robustness, and data integrity to de-risk nonclinical studies and reduce the likelihood of downstream GCP or regulatory challenges
Establishes and maintains quality oversight of external laboratories and vendors (e.g., test facilities, CROs, specialty labs, bioanalytical and biomarker partners, clinical laboratories) through risk-based qualification, governance, ongoing performance monitoring, and surveillance
Leads the design and execution of a global, risk-based vendor oversight and audit strategy aligned with GLP, OECD, ICH, and regulatory expectations, ensuring that qualification, surveillance, and audit planning are driven by inherent and emerging risk
Develops and maintains structured risk identification frameworks for new and existing vendors, enabling consistent qualification decisions, defensible oversight, and inspection-ready documentation
Serves as an upstream risk intelligence partner to R&D Quality and Regulatory functions, translating nonclinical and GLP risks into potential agency questions, inspection vulnerabilities, and mitigation strategies relevant to IND and NDA submissions
Leads quality governance and escalation for GLP vendor-related issues, including oversight of quality events, investigations, CAPAs, and executive-level risk visibility as appropriate
Provides strategic quality input into CRO and vendor operating models, evaluating process maturity, data governance, systems, and opportunities to strengthen compliance, inspection readiness, and operational effectiveness
Advises on continuous improvement of the Quality Management System to better support early development and research activities while maintaining regulatory robustness
Partners with Legal and Procurement to ensure contracts and agreements appropriately reflect GLP/OECD obligations, oversight expectations, data integrity requirements, and inspection readiness responsibilities
Qualification
Required
Educated preferably in life sciences (technology, biological science, pharmacy or other health related discipline preferred) or equivalent qualification or work experience
Minimum of 10 years of relevant experience, inclusive of bioanalytical and toxicology subject matter, as it relates to GLPs, GCPs and GCLPs
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
Direct experience in the field of assay development and validation and familiar with biomarker-based assays (e.g., PCR, ELISA, FISH) is preferred
Preferred
Master's degree in a science, technology or industry related discipline, preferred
Benefits
Medical, dental, and vision coverage
Life and disability insurance
A lifestyle reimbursement program
Flexible spending and health savings accounts
A 401(k) with a generous company match
Paid time off
Wellness days
Holidays
Two company-wide recharge breaks
Generous family resources and leave
Company
Alnylam Pharmaceuticals
Alnylam Pharmaceuticals is a biopharmaceutical company focused on the discovery, development and commercialization.
1001-5000 employees
H1B Sponsorship
Alnylam Pharmaceuticals has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2022 (18)
2021 (19)
2020 (7)
Funding
Current Stage
Public CompanyTotal Funding
$4.55BKey Investors
Blackstone Life SciencesBlackstone CreditRegeneron
2025-09-09Post Ipo Debt· $661.25M
2022-09-12Post Ipo Debt· $900M
2022-03-04IPO
Leadership Team
Yvonne Greenstreet
Chief Executive Officer
Jeff Poulton
Chief Financial Officer
Recent News
Clinical Trials Arena
2026-01-16
Longevity.Technology
2026-01-14
2026-01-13
Company data provided by crunchbase