Senior Manager, Quality, Standards and Compliance

Alnylam Pharmaceuticals•Cambridge, MA

1d•$135,400 - $183,200•Hybrid

About The Position

The Senior Manager, Quality Standards and Compliance (QSC) is responsible for developing and maintaining the Regulatory Sciences compliance framework and providing oversight of compliance-related activities across Regulatory Strategy, Regulatory Operations, Labeling, Global Safety Operations, Medical Safety and Risk Management, and International functions. The role supports compliance throughout the product lifecycle from Good Clinical Practice (GCP) through Good Pharmacovigilance Practice (GVP), ensuring alignment with internal procedures, regulatory requirements, and inspection readiness standards. Activities governed by Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP) are outside the scope of this role. The role supports the development and monitoring of Regulatory Sciences compliance metrics, provides compliance oversight and coordination of deviations and CAPAs, and serves as a key liaison with Quality Assurance. The position drives proactive risk management, governance, and continuous improvement to maintain sustainable inspection readiness across regulatory activities in scope. This position is hybrid and will be primarily located in Cambridge, MA, USA.

Requirements

Bachelor’s degree in Regulatory Affairs, Life Sciences, Pharmacy, or related field and/or a licensed healthcare professional (advanced degree preferred)
Minimum of 4 years of experience in pharmaceutical or biotechnology industry
Strong knowledge of global regulatory frameworks, regulatory operations processes, and Quality Management System expectations.
Significant experience in Regulatory Affairs and/or pharmacovigilance compliance or related quality/compliance functions
Experience supporting regulatory inspections and internal audits strongly preferred
Experience working within a Quality Management System environment and supporting cross-functional compliance governance.
Demonstrated ability to partner with functional process owners while maintaining independent oversight and quality standards.
Excellent leadership and project management skills; can establish and maintain effective relationships with customers (internal and external)
Excellent written and verbal communication skills. Able to express complex ideas.
Ability to work independently, prioritize effectively and work in a matrix team environment required

Responsibilities

Support and augment the QSC compliance framework as it applies to Regulatory Sciences activities, ensuring alignment with applicable regulatory requirements and internal Quality Management System procedures.
Provide compliance governance across relevant Regulatory Sciences subfunctions.
Identify compliance risks and implement mitigation strategies in partnership with Regulatory Sciences process owners and QSC leadership.
Collaborate with quality and compliance stakeholders across adjacent GxP functions to promote alignment, consistency, and sharing of compliance best practices.
Partner with Regulatory Sciences stakeholders to define, maintain, and monitor key performance indicators (KPIs) and compliance metrics for Regulatory Sciences activities.
Develop and maintain compliance reports and/or dashboards and periodic reporting for Regulatory Sciences leadership.
Analyze compliance trends and identify systemic issues requiring remediation or escalation.
Support oversight and management of deviations, CAPAs, and quality issues related to Regulatory Sciences activities.
Facilitate root cause analysis, CAPA development, implementation tracking, and timely closure of quality events in partnership with accountable Regulatory Sciences process owners.
Support internal audits and regulatory inspections impacting Regulatory Sciences activities.
Coordinate responses to audit observations and inspection findings related to Regulatory Sciences activities in collaboration accountable owners QA partners.
Ensure appropriate documentation and evidence are maintained to support inspection readiness.
Support inspection readiness initiatives related to Regulatory Sciences activities.
Conduct periodic readiness assessments and support remediation planning where gaps are identified.
Ensure documentation and records meet inspection expectations.
Drive continuous improvement initiatives to strengthen Regulatory Sciences operational compliance.