Senior Manager, Quality, Standards and Compliance

Alnylam Pharmaceuticals

Cambridge (MA)

Hybrid

USD 120,000 - 180,000

Full time

14 days+

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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

Overview

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 .

This position is hybrid and will be primarily located in Cambridge, MA, USA.

Key Responsibilities

Compliance Oversight for Regulatory Science

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.

KPI Monitoring & Compliance Metrics

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.

Deviation, CAPA, and Issue Management Support

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.

Quality Assurance Interface

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.

Inspection Readiness Support

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.

Governance & Process Improvement

Drive continuous improvement initiatives to strengthen Regulatory Sciences operational compliance.

** 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 pharmacovigilancecompliance 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

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.

Before applying, please review Alnylam’s CandidatePrivacy Notice regarding how Alnylam handles Personal Data you provide with your application for employment.

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.