Company Overview: Dyne Therapeutics is focused on delivering functional improvement for people living with genetically driven neuromuscular diseases. We are developing therapeutics that target muscle and the central nerv…
Skills: Quality Management Systems, GxP Compliance, Document Control, Records Management, Training Program Governance
Company Overview: Dyne Therapeutics is focused on delivering functional improvement for people living with genetically driven neuromuscular diseases. We are developing therapeutics that target muscle and the central nerv…
Skills: Global Forecasting, Market Research, Competitive Intelligence, Data Analytics, Strategic Planning
Company Overview: Dyne Therapeutics is focused on delivering functional improvement for people living with genetically driven neuromuscular diseases. We are developing therapeutics that target muscle and the central nerv…
Skills: Drug Product Manufacturing, CDMO Oversight, Sterile Manufacturing, Fill-Finish Operations, Tech Transfer
Company Overview: Dyne Therapeutics is focused on delivering functional improvement for people living with genetically driven neuromuscular diseases. We are developing therapeutics that target muscle and the central nerv…
Company Overview: Dyne Therapeutics is focused on delivering functional improvement for people living with genetically driven neuromuscular diseases. We are developing therapeutics that target muscle and the central nerv…
Company Overview: Dyne Therapeutics is focused on delivering functional improvement for people living with genetically driven neuromuscular diseases. We are developing therapeutics that target muscle and the central nerv…
Company Overview: Dyne Therapeutics is focused on delivering functional improvement for people living with genetically driven neuromuscular diseases. We are developing therapeutics that target muscle and the central nerv…
Company Overview: Dyne Therapeutics is focused on delivering functional improvement for people living with genetically driven neuromuscular diseases. We are developing therapeutics that target muscle and the central nerv…
Skills: Medical Affairs Strategy, Launch Readiness, KOL Engagement, Medical Education, Scientific Communication
Senior Program Manager, Program Leadership and Management
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$143k–$197k/yr
Senior$1.0B raised
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Cushman & Wakefield
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Waltham, Massachusetts, United States · On-site
$29/hr–$35/hr
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$160k–$195k/yr
Full-time
bachelor degree, postgraduate degree
Posted 4d ago
~40 hrs/week
Responsibilities
Lead the design, scaling, and advancement of a global Quality Management System to support the transition to commercial operations. Oversee the lifecycle of quality documents, training programs, and eQMS platforms to ensure inspection readiness and regulatory compliance.
Requirements
Requires a Bachelor's degree in a scientific discipline or Quality Systems Management and 8+ years of experience in biotech or pharma. Must have demonstrated expertise in GxP, global regulatory requirements, and the implementation of eQMS and LMS platforms.
Full job description
Company Overview:
Dyne Therapeutics is focused on delivering functional improvement for people living with genetically driven neuromuscular diseases. We are developing therapeutics that target muscle and the central nervous system (CNS) to address the root cause of disease. The company is advancing clinical programs for Duchenne muscular dystrophy (DMD) and myotonic dystrophy type 1 (DM1) as well as preclinical programs for facioscapulohumeral muscular dystrophy (FSHD), Pompe disease and multiple DMD mutations. At Dyne, we are on a mission to deliver functional improvement for individuals, families and communities. Learn more at https://www.dyne-tx.com/, and follow us on X, LinkedIn and Facebook.
Role Summary:
The Associate Director, Quality ManagementSystems is a key member of the quality teamresponsible for designing, scaling, and advancing aglobal Quality Management System (QMS) that supports Dyne’s transition to commercial operations.This role is responsible forkey elements of the QMS including document control, records management and training ensuring these systems are inspection-ready, risk-based, and aligned with global regulatory expectations.The Associate Director partners cross-functionally to embed quality as a strategic enabler of business performance, ensuring systems are fit-for-purpose, inspection-ready, scalable, and efficient as the organization grows. This is a hands-on role that requires both strategic vision and operational execution.
This role is based in Waltham, MA.
Primary Responsibilities Include:
QMS Strategy, Compliance & Inspection Readiness
Leads the evolution of the QMS into a commercial-ready, globally scalable system aligned with ICH Q10, FDA CFRs, and international regulatory standards
Ensures QMS processes are phase-appropriate, risk-based, and designed to scale with organizational growth
Establishes and sustains a proactive compliance model that supports continuous inspection readiness
Serves as a subject matter expert and primary representative for assigned QMS areas during regulatory inspections and health authority interactions
Provides strategic and operational leadership for GxP documentation and training programs, ensuring effective use and governance of the eDMS and LMS in support of the quality management system
Core QMS Program Ownership
Oversees the end-to-end lifecycle management of quality documents, including policies, SOPs, and related controlled records, ensuring consistency, accuracy, and compliance with applicable regulations that achieves inspection readiness
Drives and manage high-volume document authoring, revision, and implementation – often under accelerated timelines
Leads the planning, deployment, and governance of role-based training curriculum across functions
Leads the design and implementation of learning programs (refresher training, cross-training, etc.)
Manages the day-to-day delivery of programs to ensure consistent quality and alignment to employees and their learning goals
Drives development and review of engaging learning materials/ assessments to support learning programs utilizing multiple delivery methods
Leads technical sessions as needed to scale eDMS/LMS capabilities
Operational Excellence & Systems Enablement
Defines, monitors, and reports quality metrics and KPIs to assess system health, compliance risk, and performance trends
Drives continuous improvement initiatives to enhance efficiency, reduce risk, and strengthen QMS robustness
Leads the implementation, optimization, and governance of eQMS platforms, ensuring validated systems, strong user adoption, and effective lifecycle management
Cross-Functional Leadership & Quality Culture
Partners with cross-functional stakeholders to embed quality into business processes and decision-making
Communicates quality risks, dependencies, and tradeoffs with clarity and urgency, influencing outcomes without direct authority
Contributes to building a high-performing quality organization and models a culture of accountability, transparency, and continuous improvement
Education and Skills Requirements:
Bachelor’s degree in a scientific discipline or Quality Systems Management; advanced degree preferred
8+ years of experience in biotechnology or pharmaceutical environments, with exposure across GxPs (GCP, GLP, GMP, GVP preferred)
Demonstrated experience with direct ownership of QMS and quality systems
Deep understanding of global regulatory requirements, including FDA CFRs, ICH guidance, and EU Annex requirements
Proven experience implementing and managing eQMS platforms (e.g., Veeva eQMS, MasterControl) and Learning Management Systems
Strong strategic and operational capability, balancing vision-setting with hands-on execution
Proven ability to manage multiple complex initiatives in a fast-paced, dynamic environment
Strong judgment and risk management skills, balancing compliance, science, and business needs
Exceptional written and verbal communication skills with the ability to influence senior and cross-functional stakeholders
Highly proactive, accountable, and comfortable operating with a high degree of autonomy
#LI-Onsite
MA Pay Range
$160,000—$195,000 USD
The pay range reflects the base pay range Dyne reasonably expects to pay for this role at the time of posting. Individual compensation depends on factors such as education, experience, job-related knowledge, and demonstrated skills.
The statements contained herein reflect general details as necessary to describe the principles functions for this job, the level of knowledge and skill typically required, and the scope of responsibility, but should not be considered an all-inclusive listing of work requirements. Individuals may perform other duties as assigned, including work in other functional areas to cover absences or relief, to equalize peak work periods or otherwise balance workload.
Dyne Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.
Advancing life-transforming therapies for serious muscle diseases
Industry
Biotechnology Research
Company size
51-200 employees
Founded
2018
Headquarters
Waltham, Massachusetts
LinkedIn followers
30,585
Total funding
$2.2B
Dyne Therapeutics is focused on delivering functional improvement for people living with genetically driven neuromuscular diseases. We are developing therapeutics that target muscle and the central nervous system (CNS) to address the root cause of disease. The company is advancing clinical programs for Duchenne muscular dystrophy (DMD) and myotonic dystrophy type 1 (DM1) as well as preclinical programs for facioscapulohumeral muscular dystrophy (FSHD) and Pompe disease. At Dyne, we are on a mission to deliver functional improvement for individuals, families and communities. Learn more https://www.dyne-tx.com/.
To view our community guidelines, click here: https://bit.ly/3BYPnpK
Offices: 1560 Trapelo Rd, Waltham, Massachusetts 02451, US
Health CareBiotechnologyMedicalPharmaceuticalTherapeutics