Senior Manager, QA Compliance

SAREPTA

. Maintain GxP quality systems processes and procedures to drive quality compliance and business efficiencies .

Posted 9/19/2026full-timeAndover • Massachusetts • United StatesSenior💰 $136,000 - $170,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates extensive knowledge of GxP compliance regulations and quality assurance processes within the pharmaceutical industry, with a strong focus on managing quality records, risk assessments, and regulatory inspections. Proven ability to analyze data, drive continuous improvement, and ensure compliance through effective quality management systems.

Highest-signal resume keywords

GMP ExperienceQuality Assurance ManagementVeeva GMP Quality Management SystemUS FDA/EU Inspection ExperienceProduct Complaint Management

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Quality Record TrendingData AnalysisRisk ManagementCAPA ManagementChange Control ManagementDeviation ManagementGMP ComplianceQuality Metrics MaintenanceRegulatory SubmissionsMock Recall Execution

Soft Skills

Interpersonal SkillsTeamworkConflict ResolutionTime ManagementIndependent Work

Industry Keywords

GxP CompliancePharmaceutical IndustryBiopharmaceutical IndustryQuality EngineeringLife ScienceHealth ScienceBiologyEU GMP RequirementsProduct Recall ProcessJoint Signal Detection

About the role

Key responsibilities & impact

Maintain GxP quality systems processes and procedures to drive quality compliance and business efficiencies
Work cross-functionally with quality assurance operations, quality control, manufacturing, validation, MS&T, and external vendors
Gather, analyze, interpret, and report manufacturing and testing data for trending programs
Address adverse trends and gaps through continuous improvement
Track, manage, and complete cross-functional quality records including deviations, lab investigations, change controls, complaints, and CAPA
Maintain quality metrics and KPIs for quality record trending
Execute quarterly and annual quality record trending and escalate risks to the Quality Review Board
Provide QA oversight for risk assessments and ensure regulatory-compliant quality risk management
Support regulatory inspections, submissions, and internal/external audits
Manage observation responses from inspections, submissions, and audits
Own and manage the Product Recall process and execute the Annual Mock Recall
Escalate quality defects to health authorities as applicable
Serve as SME for Product Complaint Management and track commercial product complaints
Participate in Joint Signal Detection meetings and generate complaint/change-control metrics
Author, review, and approve GMP controlled documents, including quality manuals and compliance policies/procedures

Requirements

What you’ll need

B.S. or B.A. degree, preferably in Life Science, Health Science or Biology
Ten years relevant experience in the pharmaceutical or biopharmaceutical industry and quality assurance
Minimum of 5-10 years in a QA and/or Quality Engineering function with increasing responsibility
Significant GMP experience in commercial products and global experience
Extensive knowledge of US GxP compliance regulations and industry practices
Extensive knowledge of EU GMP requirements
Extensive knowledge of Veeva GMP Quality Management System (QMS) oversight for compliance
Experience tracking, managing, and completing Product Complaints in a commercial environment
Combination Drug compliance a plus
US FDA/EU inspection experience, participating or leading
Excellent command of spoken and written English
Ability to handle a high-pressure environment associated with meeting deadlines
Ability to work independently with minimal supervision
Ability to manage multiple concurrent projects and deliver results accurately and on time
Interpersonal skills including teamwork, listening, giving feedback, giving instructions, and conflict resolution
Candidates must be authorized to work in the U.S.

Benefits

Comp & perks

Physical and Emotional Wellness resources
Financial Wellness resources
Support for Caregivers
Comprehensive benefits package
Competitive compensation and benefit package
Hybrid work arrangement
Company-sponsored in-person events