Regulatory Quality & Compliance Leader

Alnylam Pharmaceuticals; Cambridge (MA); Hybrid; USD 120,000 - 180,000; Full time

Benefits offered by this job

Medical coverage

Dental coverage

Vision coverage

Life insurance

Disability insurance

Lifestyle reimbursement program

FSA/HSA

401(k) with generous match

Paid time off

Wellness days

Holidays

Two company-wide recharge breaks

Family resources and leave

Job summary

Alnylam Pharmaceuticals in Cambridge, MA is seeking a Senior Manager, Quality Standards and Compliance (QSC) to lead the Regulatory Sciences compliance framework across strategy, operations, labeling, and pharmacovigilance activities. You will oversee deviations, CAPAs, audits, and inspection readiness, partnering with QA and cross-functional teams to strengthen governance and continuous improvement.

The role requires a bachelor’s in regulatory affairs or life sciences, 4+ years in

Qualifications

• 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
• Define, maintain, and monitor KPIs and compliance metrics for Regulatory Sciences activities
• Develop and maintain compliance reports and 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

Skills

Regulatory leadership

Quality management

Regulatory inspections

Cross-functional collaboration

Project management

Communication

Independent work

Education

Bachelor’s degree in Regulatory Affairs or Life Sciences

Advanced degree preferred

Tools

Quality Management System (QMS)

Job description

Alnylam Pharmaceuticals in Cambridge, MA is seeking a Senior Manager, Quality Standards and Compliance (QSC) to lead the Regulatory Sciences compliance framework across strategy, operations, labeling, and pharmacovigilance activities. You will oversee deviations, CAPAs, audits, and inspection readiness, partnering with QA and cross-functional teams to strengthen governance and continuous improvement.

The role requires a bachelor’s in regulatory affairs or life sciences, 4+ years in