New · posted Nov 14
Alnylam Pharmaceuticals · Biotechnology
Senior Manager, R&D Quality Assurance
- Cambridge, MA
- Hybrid
- Full-time
- Manager
The role
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.
The pay range below reflects the full-time base salary range we expect to pay for this role at the time of posting. Base pay will be determined based on a number of factors including, but not limited to, relevant experience, skills, and education. 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).
What you need
- 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).
What you'll do
- 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.
Pay and benefits
$135,400 – $183,200 a year
Employer providedMedical, dental, and vision coverage
Life and disability insurance
401(k) with company match
Paid time off and wellness days
Annual bonus and equity eligibility
Family resources and leave
Where you'll work
Cambridge, MAHybridOpen in Maps (opens in a new tab)
More jobs in Cambridge, MA
From the posting
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.
Alnylam’s robust Total Rewards package is designed to support your overall health and well-being. We offer comprehensive benefits including medical, dental, and vision coverage, life and disability insurance, a lifestyle reimbursement program, flexible spending and health savings accounts and a 401(k)with a generous company match. Eligible employees enjoy paid time off, wellness days, holidays, and two company-wide recharge breaks. We also offer generous family resources and leave. Our commitment to your well-being reflects our belief that caring for our people fuels the impact we create together.
Learn more about these and additional benefits offered by Alnylam by visiting the Benefits section of the Careers website: https://www.alnylam.com/careers
U.S. Pay Range
$135,400—$183,200 USD
Equal opportunity, accessibility and legal noticesAlnylam Pharmaceuticals's statements, word for word
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.
Job intelligence
The context around this role
Live data · November 14, 2026
Salary intelligence
How the pay compares
This roleEmployer provided
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $135,400 | — | $183,200 |
This role: Alnylam Pharmaceuticals's own published range.
Career trajectory
Where this role sits in Clinical Quality Assurance
The general path across 14 open Clinical Quality Assurance roles on Regulatory Jobs, with the titles they carry most. Not Alnylam's own promotion track.
Career resources on Clinical Quality Assurance
Skills DNA
What this role leans on
How many of the posting's 17 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- GMP and compliance12
- Clinical trial conduct9
- Collaboration and leadership6
- Documentation and SOPs3
- Investigations and CAPA2
- Quality systems and risk2
- Validation and qualification1
- Regulatory submissions1
- Data and digital systems1
Regulatory intelligence
The rules, regulations and standards behind this role
The regulations, guidance and standards that govern Clinical Quality Assurance work in biotechnology, led by the two this posting names, each linked to the agency or standards body that publishes it.
- ICHICH E6(R3) good clinical practice(official source, opens in a new tab)The international standard for the design, conduct and reporting of clinical trialsNamed in the posting
- PMDAJapan PMDA(official source, opens in a new tab)Japan's Pharmaceuticals and Medical Devices AgencyNamed in the posting
- FDAFDA Bioresearch Monitoring (BIMO)(official source, opens in a new tab)FDA inspections of clinical investigators, sponsors, IRBs and GLP labs
- FDA21 CFR Part 312(official source, opens in a new tab)Investigational New Drug applications and sponsor duties in drug trials
- FDA21 CFR Part 50(official source, opens in a new tab)Protection of human subjects: informed consent in FDA-regulated trials
- FDAFDA Investigations Operations Manual(official source, opens in a new tab)How FDA investigators plan and conduct inspections
- ISOISO 19011(official source, opens in a new tab)Guidelines for auditing management systems
- MHRAUK MHRA(official source, opens in a new tab)The UK regulator of medicines and medical devices, including UKCA marking
- FDA21 CFR Part 56(official source, opens in a new tab)Institutional review boards for FDA-regulated clinical investigations
- FDA21 CFR Part 11(official source, opens in a new tab)FDA rules for electronic records and electronic signatures
- FDA21 CFR Part 58 (GLP)(official source, opens in a new tab)Good laboratory practice for nonclinical laboratory studies
- EUEU Clinical Trials Regulation 536/2014(official source, opens in a new tab)How clinical trials of medicines are authorized and run in the EU, through CTIS
- FDAFDA data integrity guidance(official source, opens in a new tab)Data Integrity and Compliance With Drug CGMP: Questions and Answers
- ICHICH E2A to E2F(official source, opens in a new tab)Clinical safety data management, expedited reporting and periodic safety reports
- HHS45 CFR Part 46 (Common Rule)(official source, opens in a new tab)The federal policy for the protection of human research subjects
- NIH42 CFR Part 11(official source, opens in a new tab)Clinical trial registration and results reporting on ClinicalTrials.gov
Company hiring pulse
Alnylam on Regulatory Jobs
- 19
- Open roles
- 19
- Distinct roles
- 5
- Locations
By discipline
- Clinical14 70%
- Regulatory3 15%
- Quality3 15%
By level
- Director12 60%
- Manager4 20%
- Associate & Specialist2 10%
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Senior Manager, R&D Quality Assurance at Alnylam
Open until filled. $135K–$183K a year, employer provided.