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: 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.
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.
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