Senior Manager - R&D Quality Assurance

Overview:

The Senior Manager, R&D Quality Assurance independently performs the R&D QA Program Lead role for assigned clinical studies, providing Clinical Quality Assurance oversight in accordance with study protocols, company procedures, GCP requirements, and applicable local and international regulations. The role leads and supports quality oversight, audit, and inspection-readiness activities and works cross-functionally to identify, assess, mitigate, and escalate quality and compliance risks. The Senior Manager also provides guidance and oversight to junior R&D QA staff, as applicable, and supports continuous improvement activities within R&D Quality Assurance.

This is a hybrid role that can be based in Cambridge, MA; Philadelphia, PA; or Maidenhead, UK, with three days per week onsite.

Key Responsibilities:

• Independently perform the R&D QA Program Lead role for assigned clinical studies, providing Clinical Quality Assurance oversight in accordance with study protocols, company procedures, GCP requirements, and applicable local and international regulations, with escalation to the GCP QA Director as appropriate.
• Provide quality oversight for assigned clinical studies, including identification, assessment, mitigation, and escalation of quality and compliance risks and support for the investigation and resolution of Quality Events and CAPAs.
• Lead and support GCP audit activities, including investigator site, vendor, study, and process audits, as applicable, and ensure audit observations and associated corrective and preventive actions are appropriately addressed.
• Lead inspection-readiness activities for assigned clinical studies, including coordination of QA and cross-functional activities, identification and mitigation of potential inspection risks, and preparation for FDA, EMA, PMDA, and other Health Authority inspections.
• Establish and maintain effective working relationships with internal Alnylam Expertise Area leads, study teams, vendors, and external partners to support study quality, compliance, and inspection-readiness activities.
• Maintain current knowledge of applicable global GCP regulations, regulatory guidance, and industry practices and support continuous improvement of R&D QA processes, procedures, and tools, as applicable.
• Provide guidance, coaching, and oversight to assigned junior R&D QA staff, as applicable, to support effective execution of assigned activities and continued development.

Qualifications:

• Bachelor’s degree, preferably life science (technology, biological science, pharmacy, or other health related discipline preferred) or equivalent qualification or clinical research experience. Master’s degree in a science, technology, or industry related discipline, preferred.
• Seven years’ experience in GCP Quality Assurance, or similar experience working in GCP and clinical trial that support pharmaceutical development.
• Experience in overseeing late phase clinical trials
• Experience in leading audits preferred.
• Experience supporting and leading inspections readiness efforts and direct inspection experience.
• Extensive experience working with different Quality Assurance functions, knowledge of Auditing, Clinical Supply Chain, Clinical Operations, Monitoring, Regulatory Affairs, Clinical Research, Drug Safety, Data Management, Programming and Statistics
• Strong working knowledge & knowledge of how to interpret GCP regulations as well as industry guidance (e.g., FDA, EMA, and other national agencies).

About Alnylam

We are the leader in RNAi therapeutics – a revolutionary approach with the potential to transform the lives of people with rare and common diseases. Built on Nobel Prize-winning science, Alnylam has delivered the breakthroughs that made RNAi therapeutics possible and are just at the beginning of what’s possible. Our deep pipeline, late-stage programs, and bold vision reflect our core values: fierce innovation, passion for excellence, purposeful urgency, open culture and commitment to people. We're proud to be a globally recognized top employer, where an authentic, inclusive culture and breakthrough thinking fuel one another.

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.

Before applying, please review Alnylam's ⁠Candidate Privacy Notice regarding how Alnylam handles Personal Data you provide with your application for employment.

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U.S. Pay Range 135400 - 183200 USD