数字质量合规高级经理

Associate Director,Digital Quality Compliance
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.

U.S. Pay Range
$164,500.00 - $222,500.00
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:
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.
Originally posted on Himalayas