Manager, GxP Vendor/Supplier Audits

Overview

The Manager, GxP Vendor/Supplier Audits, is responsible for managing the global GxP (GMP, GDP, GCP, GLP, and GPV) vendor and supplier audit program. This role ensures external partners meet applicable regulatory requirements and internal standards, supports inspection readiness, and drives continuous improvement in vendor oversight practices.

The Manager will lead risk-based planning and execution of audits, oversee qualification and requalification of service providers, and collaborate cross-functionally to ensure consistent vendor performance and compliance across the product lifecycle.

This position is flexible and may be hybrid or virtual, with travel required as needed.

Key Responsibilities

• Lead the development and execution of the global GxP vendor/supplier audit program, including GMP, GDP, GCP, GLP, and GPV domains.
• Manage vendor qualification and requalification processes in alignment with applicable regulations and internal standards.
• Plan, lead, and perform audits of external vendors, contract manufacturers, laboratories, CROs, and service providers.
• Maintain and prioritize a risk-based audit schedule in collaboration with stakeholders.
• Oversee documentation, follow-up, and closure of audit findings, ensuring appropriate corrective and preventive actions (CAPAs) are implemented.
• Support global inspection readiness activities related to vendor oversight and represent the audit program during internal audits, partner audits, and inspections, as needed.
• Monitor trends in vendor performance and audit findings to inform Quality and business decision-making.
• Partner with cross-functional teams to streamline auditing workflows and ensure audit-related data is current and reliable.
• Provide subject matter expertise in GxP vendor audit requirements and expectations across the product lifecycle.
• Ensure training, tools, and resources are in place for a robust GxP audit program.
• Continually evaluate and improve processes to align with evolving industry best practices and regulatory expectations. 

Qualifications

• Bachelor’s degree in life sciences, pharmacy, or a related field is preferred; equivalent relevant industry experience will also be considered.
• Minimum of 5+ years of experience in pharmaceutical or biotechnology Quality Assurance, with a strong focus on GxP audits and compliance.
• Demonstrated experience leading comprehensive audit programs and managing internal and external audit plans across diverse GxP areas.
• Strong understanding of global regulatory requirements and standards (e.g., FDA, EMA, MHRA, ICH, PIC/S) and their application to audit programs.
• Experience auditing CROs, contract labs, and PV service providers is helpful.
• Experience supporting audits and inspections, including coordination with site-based teams and backroom planning.
• Excellent communication and collaboration skills with the ability to work cross-functionally and influence without direct authority.
• Experience with electronic audit systems and quality management tools (e.g., Veeva, AuditUtopia) preferred.
• Ability to travel up to 20%, between domestic sites and including international travel as needed.

U.S. Pay Range

$119,800.00 - $162,000.00

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

About Alnylam

We are the leader in RNAi therapeutics – a revolutionary approach 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 possible and 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, where an authentic, inclusive culture and breakthrough thinking fuel 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.