Senior Director, Audits, Inspections, & QMS

Overview

Reporting to the SVP, Head of Quality Assurance & Quality Control, this is an enterprise leadership role and is responsible for providing strategic and operational leadership in the planning and execution of various elements across the Quality Management Systems (QMS). To include all GxP audit programs across research, development, manufacturing, supply chain, regulatory, marketing and commercial, as well as direct oversight of the successful execution of all global, regulatory, GxP inspections. This role is the owner and decision-maker administering Alnylam's Quality Management Systems (QMS), inclusive of elements such as deviations, corrective / preventative actions, document control, training, etc.

This individual acts in a capacity such that they represent Alnylam to both external entities and senior internal stakeholders and requires the ability to influence and negotiate complex and time-sensitive interactions. They are also responsible to ensure and oversee QMS / GxP governance forums and that monitoring activities are in place and are designed to demonstrate the health of Alnylam's quality systems.

This position can be hybrid or onsite, with occasional on-site presence required in Cambride, MA.

Key Responsibilities

Audits & Inspections :

• Will maintain and oversee GxP Audit Programs and ensure audit planning is executed at a minimum annually (i.e., annual audit plans).
• Responsible to execute GxP audits in accordance with the approved plans, to include both internal (process) audits, external supplier / vendor audits, and external entities such as Investigator sites, IRBs, CROs, CMOs, partner audits, Safety Data Exchange Audits, etc.
• Responsible to execute oversight programs that ensure third parties (e.g., vendors, suppliers, etc.) are appropriately qualified and continued quality oversight is maintained (e.g., Quality Agreements, routine audits, etc.).
• This role will also define and execute global audit / inspection standards for external entities that audit or inspect Alnylam (e.g., development / marketing partners, regulatory inspections, etc.)
• Ensures timely submission of regulatory inspection responses and maintains oversight to ensure all regulatory inspection commitments are actioned and completed timely.
• Is the Quality representative and liaison for all Internal Audit (Finance) and Compliance & Ethics initiatives, interactions and shared work processes.

QMS :

Qualifications

U.S. Pay Range

$217,000.00 - $293,600.00

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, Alnylam has 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.