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.
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).
About Alnylam: Alnylam Pharmaceuticals (Nasdaq: ALNY) has led the translation of RNA interference (RNAi) into a whole new class of innovative medicines with the potential to transform the lives of people afflicted with rare and more prevalent diseases. Based on Nobel Prize-winning science, RNAi therapeutics represent a powerful, clinically validated approach to treating diseases at their genetic source by “interfering” with mRNA that cause or contribute to disease. Since our founding in 2002, Alnylam has led the RNAi Revolution and continues to turn scientific possibility into reality.
Our culture: Our people-first culture is guided by our core values: fiercely innovative, open culture, purposeful urgency, passion for excellence, and commitment to people, and these values influence how we work and the business decisions we make. Thanks to feedback from our employees over the years, we’ve been fortunate to be named a top employer around the world. Alnylam is extremely proud to have been recognized as one of Science Magazine’s Top Biopharma Employers, one of America's Most Responsible Companies for 2024 by Newsweek, a Fast Company Best Workplace for Innovators, and a Great Place to Work in Canada, France, Italy, Spain, Switzerland, and UK – among others.
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.
Where you'll work
Cambridge, MAHybridOpen in Maps (opens in a new tab)
More jobs in Cambridge, MAEqual opportunity, accessibility and legal noticesAlnylam Pharmaceuticals's statements, word for word
At Alnylam, we commit to an inclusive recruitment process and equal employment opportunity. We are dedicated to building an environment where employees can feel that they belong, can bring their authentic selves to work, and achieve to their full potential. By empowering employees to embrace their unique differences at work, our business grows stronger with advanced and original thinking, allowing us to bring groundbreaking medicines to patients.
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
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 18 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
- Validation and qualification2
- Quality systems and risk2
- 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%
More roles at Alnylam
- View role
Senior Manager, R&D Quality Assurance
Cambridge, MA · HybridManagerBiotechnology$135K
- View role
Executive Director, Clinical Research - Neurodegeneration
Cambridge, MA · HybridDirectorBiotechnologySalary not listed
- View role
Director, Clinical Research- Benign Hematology
Philadelphia, PA +1 more · HybridDirectorBiotechnology$255K
- View role
Senior Manager, Clinical Trial Disclosure and Transparency
United StatesManagerBiotechnology$140K
Similar Clinical Quality Assurance roles elsewhere
- View role
Senior Manager, Development Quality Assurance
InsmedRemote, USManagerBiotechnology$124K–$161K
Senior Manager, R&D Quality Assurance at Alnylam
Open until filled.