Associate Director, Quality Assurance

Alnylam Pharmaceuticals, Inc.; Northern (KY); Hybrid; USD 170,000 - 210,000; Full time

Job summary

Alnylam Pharmaceuticals, Inc. seeks an Associate Director to lead Quality digital capabilities and enterprise systems.

You will translate Quality needs into scalable digital requirements and shape the roadmap for SAP, Veeva, LIMS and related platforms, partnering with IT and governance bodies to ensure compliant, efficient operations. The role emphasizes data integrity, global operations, validation, and change control across QA/QC systems, with a focus on cross-functional collaboration and

Qualifications

• Bachelor's degree in Life Sciences, Engineering, Computer Science, or related field.
• 8+ years of experience in Quality or related areas within biotechnology or pharmaceutical industries with a strong understanding of GxP Quality data domains.
• 5+ years experience with SAP in a Quality context including SAP Quality Management or equivalent modules and integrations with LIMS, MES, and QMS platforms.
• 7+ years of experience with Veeva Vault Quality or similar QMS technology.
• Knowledge of complementary systems (ERP, LIMS, MES).
• Experience with Quality Risk Management (ICH Q9) to drive risk-based decision-making, prioritization, and continuous improvement across GxP processes.
• Experience translating complex data into clear, actionable insights for senior leaders and governance forums; strong written and verbal communication skills.

Responsibilities

• Lead the development and definition of the multi-year roadmap for Quality digital capabilities, with emphasis on SAP, Veeva and LIMS.
• Drive prioritization and delivery of Quality capability improvements through governance forums and stakeholder alignment.
• Provide Quality business ownership for QA/QC digital capabilities (e.g., Veeva, LIMS, SAP, Kneat, DocuSign).
• Serve as the primary translator between Quality and IT/SAP & Veeva Center of Excellence teams.
• Drive standardization and simplification of Quality processes enabled through SAP, Veeva, LIMS, etc.
• Evaluate IT system features and modules for applicability to Quality and lead adoption where value is shown.
• Support Quality data governance, definitions, standards, traceability, and lineage for metrics and audit-ready reporting.
• Support release planning and change control for QA/QC systems, ensuring validation, training and records.
• Ensure high-quality, inspection-ready documentation in alignment with QMS.
• Provide guidance to Quality users on compliant use of Quality systems and data.
• Lead periodic Quality reviews of system performance and compliance posture across QA, IT and functional groups.
• Contribute to validation strategy with Quality Risk Management principles.
• Maintain strong functional knowledge of Veeva Vault Quality, LIMS and SAP capabilities.
• Coordinate with owners of other Veeva Vaults and GxP systems to promote end-to-end process consistency.
• Facilitate governance forums for Quality and TOQ capability requests with risk-based decision-making.

Skills

Quality systems

GxP

Veeva Vault Quality

SAP QM

LIMS

Data governance

Stakeholder management

Communication

Education

Bachelor's degree in Life Sciences, Engineering, Computer Science, or related field

Tools

SAP

Veeva Vault Quality

LIMS

DocuSign

Kneat

Ready Room

Job description

This role serves as a business system owner and leader for Quality digital capabilities, with accountability for shaping and advancing enterprise Quality technologies, including SAP, Veeva, LIMS, DocuSign, Kneat, Quality Insights & Analytics Dashboards and integrated platforms.

This individual supports the business system ownership function, responsible for day-to-day administration, execution, and operational decision support for Quality Assurance (QA) and Quality Control (QC)–owned systems, including Veeva, LIMS, SAP, DocuSign, and Quality Insights & Analytics dashboards in partnership with IT.

The role supports ongoing continuous improvement and modernization of GxP Quality Systems that enable compliant, efficient, and scalable Quality operations across Alnylam’s global organization and adjacent functions.

The Associate Director is responsible for translating Quality business needs into scalable, compliant, and scalable enabled digital requirements, acting as the primary bridge between Quality, IT, and enterprise digital functions. This includes informing the roadmap for capabilities supporting Quality processes, driving system evolution, enabling cross-platform integrations, and evaluating emerging solutions to advance operational excellence and data integrity across the enterprise.

The position requires strong collaboration and communication skills and ability to influence within cross-functional forums to connect innovation with practical execution and operational excellence.

Additionally, this role partners with Quality, IT and business stakeholders to drive data integrity, data governance and compliance initiatives to strengthen enterprise data quality and data standards.

This role is considered Virtual.

Key Responsibilities:

• Lead the development and definition of the multi-year roadmap for Quality digital capabilities, with a strong emphasis on SAP, Veeva and LIMS enterprise systems.
• Drive prioritization and delivery of Quality capability improvements through governance forums, aligning stakeholders on scope, risk, and adoption to strengthen GxP compliance, inspection readiness, and end-to-end process effectiveness in partnership with IT.
• Provide Quality business ownership for QA/QC digital capabilities (e.g., Veeva, LIMS, SAP, Kneat, Docusign, Ready Room, etc.), partnering with process owners, business users, IT and vendors to ensure validated, compliant operation and value-driven enhancements in partnership with IT.
• Serve as the primary translator between Quality and IT/SAP & Veeva Center of Excellence teams, converting complex Quality requirements into clear, structured functional and system requirements
• Drive standardization and simplification of Quality processes enabled through SAP, Veeva, LIMS, etc. reducing customization and enabling sustainable global operations
• Evaluate impact of IT System new features, modules, and capabilities, determining applicability to Quality and leading adoption where value is demonstrated.
• Support Quality data governance (definitions, standards, traceability, and lineage) to enable consistent metrics, audit-ready reporting, and reliable trending across Quality processes.
• Support release planning and change control for QA/ QC systems, ensuring impact to procedures, validation state, training, and Quality records are assessed and appropriately implemented.
• Ensure high-quality, inspection-ready documentation for Quality-owned capabilities (e.g., business requirements, process maps, configuration decisions, and validation deliverables) in alignment with the QMS.
• Provide guidance to Quality users and super-users on compliant use of Quality systems and data, including procedure adherence, inspection-ready execution, and effective issue triage and escalation.
• Lead periodic Quality reviews of system performance and compliance posture (e.g., access/ roles, audit trail review, data integrity controls, procedural adherence), partnering across QA, IT and functional groups to ensure ongoing alignment with applicable regulations and internal standards.
• Contribute to validation strategy and planning by applying Quality Risk Management principles to right-size validation activities and focus testing and controls on patient safety, product quality, and compliance risk.
• Maintain strong functional knowledge of Veeva Vault Quality, LIMS and SAP capabilities and industry best practices, leveraging community and partner networks to inform compliant use and continuous improvement.
• Coordinate with owners of other Veeva Vaults and GxP systems (LIMS, SAP and DocuSign) to promote end-to-end process consistency and compliant data exchange in partnership with IT.
• Facilitate governance forums for Quality and Technical Operations Quality (TOQ) capability requests, ensuring transparent prioritization, risk-based decision-making, and alignment to Quality objectives.

Qualifications:

• Bachelor's degree in Life Sciences, Engineering, Computer Science, or related field
• 8+ years of experience in Quality or related areas within biotechnology or pharmaceutical industries with a strong understanding of GxP Quality data domains (e.g., Quality Events/Deviations, CAPA, Change Control, Complaints, Materials Quality Management, Batch Disposition and Market Allocation and the use of metrics to monitor throughput, performance and risk.
• 5 +years experience working with SAP in a Quality context including SAP Quality Management (QM) or equivalent modules and integrations with LIMS, MES, and QMS platforms.
• 7+ years of experience with Veeva Vault Quality or similar QMS technology
• Knowledge of complementary systems (e.g., ERP, LIMS, MES)
• Strong understanding of GxP Quality data domains (e.g., Quality Events/Deviations, CAPA, Change Control, Complaints) and the use of metrics to monitor performance and risk.
• Experience with Quality Risk Management (ICH Q9) to drive risk-based decision-making, prioritization, and continuous improvement across GxP processes.
• Experience translating complex data into clear, actionable insights for senior leaders and governance forums; strong written and verbal communication skills.

About Alnylam

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.

The pay range below 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.

State Specific Applicant Notices

• Arizona Applicants: To the extent required by applicable law, the Company maintains a smoke-free workplace.
• Maryland Applicants:
  • UNDER MARYLAND LAW, AN EMPLOYER MAY NOT REQUIRE OR DEMAND, AS A CONDITION OF EMPLOYMENT, PROSPECTIVE EMPLOYMENT OR CONTINUED EMPLOYMENT, THAT AN INDIVIDUAL SUBMIT TO OR TAKE A LIE DETECTOR OR SIMILAR TEST. AN EMPLOYER WHO VIOLATES THIS LAW IS GUILTY OF A MISDEMEANOR AND SUBJECT TO A FINE NOT EXCEEDING $100.
  • The Company considers this Application for Employment to be a part of the personnel record.
• Massachusetts (MA) Applicants: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability
• Rhode Island (RI) Applicants: The Company is subject to Chapters 29-38 of Title 28 of the General Laws of Rhode Island, and is therefore covered by the state's workers' compensation law.