Executive Director, Quality Assurance

Harmony Biosciences LLC•Plymouth Meeting, PA

2d•Hybrid

About The Position

Harmony Biosciences is recruiting for an Executive Director, Quality Assurance in our Plymouth Meeting Office. The Executive Director, Quality Assurance is a senior quality leader responsible for establishing and advancing an integrated, phase-appropriate Quality organization that supports clinical development through commercialization. This role provides strategic and operational leadership for Quality Assurance CMC, Quality Systems, Quality Control oversight, Analytical Quality, Stability Quality, and GMP/GDP/GLP compliance activities across development and commercial programs. This role serves as the primary Quality liaison on CMC teams, ensuring all Quality functions are aligned, integrated, and operating cohesively to deliver compliant, risk-appropriate solutions that support development objectives, regulatory expectations, and uninterrupted product supply. This role partners closely with CMC & Technical Operations, Regulatory Affairs, Pharmaceutical Development, Clinical Operations, Supply Chain, and external manufacturing partners to ensure robust quality oversight, inspection readiness, and successful execution of key clinical and commercial milestones.

Requirements

Bachelor of Science required
Minimum of 15 years of progressive Quality experience within the pharmaceutical or biotechnology industry.
Minimum of 10 years of leadership experience managing diverse Quality organizations in both development and commercial environments.
Demonstrated experience serving as a strategic Quality leader within cross-functional CMC or product development teams.
Experience supporting global regulatory submissions and interactions across clinical and commercial programs.
Experience overseeing quality activities at CDMOs, contract laboratories, and global supply partners.
Deep understanding of GxP requirements including GMP, GDP, GLP, FDA, EMA, and ICH regulations and guidance.
Strong working knowledge of pharmaceutical development, manufacturing, analytical testing, stability programs, specifications management, validation, and lifecycle management.

Nice To Haves

MS or PhD preferred in Quality, Regulatory Affairs, Pharmacy, Chemistry or Biology or related field strongly preferred.

Responsibilities

Lead and evolve a comprehensive, risk-based Quality Management System (QMS) that supports development and commercial products in compliance with global regulatory requirements including FDA, EMA, ICH, GMP, GDP, and GLP expectations.
Serve as the Quality point of contact and empowered decision-maker on cross-functional CMC Strategy teams, acting as the single Quality point of contact for development and commercial programs, ensuring alignment and integration across all Quality functions to provide a unified “One Quality Voice” to internal stakeholders and external partners.
Provide strategic quality leadership for clinical development, process validation, commercialization activities, lifecycle management, and post-approval changes.
Develop and execute long-term quality strategies aligned with corporate objectives, regulatory commitments, product lifecycle needs, and business growth plans.
Direct and coordinate quality sub-teams supporting clinical and commercial programs, including Quality Assurance Operations, Quality Control, Analytical Quality, Stability, Specifications, and Quality Systems personnel.
Partner with cross-functional CMC and asset teams to support strategic planning for key development, regulatory, manufacturing, and commercialization milestones while ensuring compliant and continuous product supply.
Ensure effective implementation and continuous improvement of quality processes and systems that support compliant operations and scalable business growth.
Provide strategic oversight of CDMOs, contract laboratories, suppliers, and external partners supporting development and commercial products.
Ensure external partners maintain compliance with applicable regulatory requirements and company quality standards.
Build, lead, mentor, and develop high-performing Quality teams capable of supporting a growing development and commercial organization.
Manage departmental budgets, resource planning, and organizational capabilities to ensure efficient execution of company priorities.
Provide executive oversight of core Quality Systems including: Deviations and investigations, CAPA management, Change control, Document management, Training systems, Supplier and CDMO quality management, Internal and external audit programs, Complaint handling, Risk management, Data integrity and inspection readiness programs.
Provide leadership and oversight for Quality Assurance CMC, Quality Systems, Analytical Quality, and related quality functions, and recruit, develop, mentor, and retain top talent within the Quality organization.
Establish organizational structure, succession planning, and capability development strategies to support business growth and enforce the matrixed CMC operating model.
Carries out supervisory responsibilities in accordance with the organization’s policies and applicable laws.