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

U.S. Pay Range

$289,000.00 - $391,000.00

The pay range 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).

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

AboutAlnylam

We are the leader in RNAi therapeutics- a revolutionaryapproach with the potential to transform the lives of people with rare and common diseases. Built on Nobel Prize-winning science,Alnylamhas delivered the breakthroughs that made RNAi therapeutics possibleand 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, wherean authentic, inclusive culture and breakthrough thinkingfuel 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.