Vice President, R&D Quality

The Vice President, R&D Quality is an enterprise leadership role responsible for the strategic vision and operational execution of R&D quality activities. This position is a member of the Quality Leadership Team (QLT) and will report to the Senior Vice President (SVP) of Quality.

The Vice President, R&D Quality will set the strategic direction and provide direction and oversight for all R&D Quality operations across Research and Development. This role will establish strong partnerships across various key stakeholders, such as Clinical Operations, Medical Affairs, Regulatory Affairs, Global Patient Safety & Risk Management (GPSRM), Legal, Data Science Statistics & Epidemiology (DSSE), Early Development, etc.

This role will engage and influence with both external and internal partners, including senior levels of Alnylam management across the enterprise, to ensure the execution of the R&D Quality goals and objectives and achieving corporate milestones and company objectives.

The Vice President, R&D Quality will ensure adequate infrastructure, process and resource are deployed to enable and ensure compliance and operational excellence throughout the R&D enterprise.

• Provide leadership and strategic direction to the R&D Quality team, including effective and timely communications that drive operational excellence and establish quality standards
• Provide oversight of GCP/GVP/GLP/RWE projects and programs and ensure that Alnylam programs are conducted in accordance with current regulations and industry guidelines
• Ensure planning and execution of all R&D Quality activities, to support business partners in the execution of critical activities associated with non-clinical (GLP) work, clinical trials (GCP), pharmacovigilance activities (GVP), as well as real-world, epidemiological studies (RWE).
• Partner with key stakeholders involved in clinical trial work and ensure strong Quality oversight of vendors and partner Clinical Research Organizations (CROs), to include facilitating routine QA-to-QA interactions, sharing and assessing quality and compliance metrics and key indicators, ensuring appropriate Corrective and Preventative Action (CAPA) plans and remediations are executed.
• Partner with key stakeholders within Clinical Operations and DSSE to execute investigator site quality programs that enable inspection-ready performance at all times
• Ensure process and practice are in place to perform risk and gap analyses of existing systems and processes; and that identified quality improvements are implemented, in compliance with regulatory standards
• Provide support and expertise for the execution of R&D audit activities (international and domestic), including participation in risk assessments and support of audit activities. This includes support for internal audit programs, as well as external (e.g., process audits, clinical investigator sites, contract clinical laboratories, contract bioanalytical laboratories, CROs, etc.)
• Proactively identify quality issues/discrepancies, and lead efforts to effectively resolve, in collaboration with internal and external partners
• Ensure robust quality investigations are conducted and escalated timely, including potential Serious Breaches, and the implementation of effective Corrective and Preventative Action (CAPA) plans
• Lead inspection readiness preparations (internal and external), with the goal of achieving successful regulatory inspection outcomes (i.e., no critical observation)
• Support inspection activities, including hosting and interacting with regulatory agencies during inspections
• Provide Quality interface with alliance partners, to include sharing quality compliance outputs, the exchange of safety data (e.g., SDEAs, etc.)
• Maintain an effective and current R&D Quality training program

• Bachelor of Arts or Science in a life science, or related fields. Advanced degrees desired (e.g., Masters degree, PhD, MBA, etc.)
• Twenty (+) years of direct experience in GLP, GCP, GVP, and Quality Systems, providing exposure throughout the drug development lifecycle
• Direct experience with global regulations and Health Agency guidance, such as ICH
• Direct experience in Health Agency inspections

• A minimum of 10 years of experience in a leadership role, demonstrating strong leadership competencies
• Must have strong attention to detail, time management and investigative skills, as well as the ability to manage multiple priorities with aggressive timelines.
• Must have strong written and oral communication skills

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 the #1 Large Employer by Boston Globe Top Places to Work in 2023 for the third consecutive year, 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. Qualified applicants will receive consideration for employment without regard to their race, color, religion, age, sex, sexual orientation, gender identity or expression, national origin, ethnicity, marital status, protected veteran status, disability, or any other characteristics prohibited by law.