Director/Associate Director, Quality Management Systems

Job Description

Job Description

Description:

The Director/Associate Director, Quality Management Systems, reporting directly to the Senior Director, Head of Quality, will be responsible for the global Quality Management System (QMS). This role is responsible for key elements of the QMS including Document Control, Records Management, Training, Deviation and CAPA, Change Control and some Risk Management responsibilities. Ensuring these systems are inspection-ready, risk-based, and aligned with global regulatory expectations. This position 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.

The Director/Associate Director, QMS will help to establish, maintain, and ensure effectiveness of quality programs and documentation to assure compliance and inspection readiness with regards to quality requirements, and regulatory standards while supporting continuous improvement and the potential of commercialization.

The ideal candidate will be based in the Boston area with 3 days in office in Norwood, MA

Essential Functions and Duties:

QMS Functional Responsibilities

• Lead and continuously improve Quality Systems, including Document Control/Management, Training, CAPA, Deviations, Change Control and Risk Management
• Oversee 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
• Support and manage document authoring, revision, and implementation
• Lead the planning, deployment, and governance of role-based training curriculum across functions
• Lead the design and implementation of learning programs (refresher training, cross-training, etc.)
• Support and sometimes lead Deviations and CAPA, Change Controls and Risk Management responsibilities
• Support and help lead the Quality functions for continuous inspection readiness, ensuring sustained audit preparedness through proactive monitoring
• Support regulatory inspections and client audits, ensuring effective preparation, execution, and follow-up
• Partner with cross-functional stakeholders to embed quality into business processes and decision-making
• Support the Quality Management Review (QMR) process, monitoring system health, identifying trends and risks, and driving continuous system and process improvements

eQMS System Requirements

• Serve as Quality System Owner for eQMS, accountable for system strategy, lifecycle, performance, and adoption
• Ensure systems remain validated and compliant with Part 11, Annex 11, and CSA expectations, while improving operational efficiency
• Lead or oversee eQMS validation, maintenance and implementation
• Hold teams accountable for system utilization and performance outcomes, while empowering new ideas and approaches
• Act as a primary influencer for enterprise-wide adoption and effective use of Quality Systems
• Act as a Quality Operational Excellence Champion, driving process simplification, standardization, and cycle time improvements
• Eliminate non-value-added activities and improve right-first-time performance
• Establish and track metrics for system effectiveness, adoption, and process efficiency
• Lead the QMS Business System Governance process, including ownership, accountability, and prioritization of enhancements for the QMS systems
• Foster a culture of open-minded thinking, accountability, and innovation

Education and Experience:

• Requires degree-level in education in a life Science (BSc, MSc, PhD). Other education background will be considered, if experience is sufficient.
• 10+ years relevant work experience within the GxP Biotechnology/Pharmaceutical industry.

Knowledge, Skills, and Abilities:

• Knowledge of GxPs, FDA, MHRA and EMA regulatory requirements
• Experience with eQMS oversight validation, maintenance and implementation
• Effective communication skills (verbal and written) for interactions across functional areas and for interactions with key regulatory agencies.
• Must have ability to utilize knowledge and interpersonal skills to provide direction and development cross-functionally and regionally, at all organization levels
• Well organized and detail-oriented; must be able to effectively prioritize work
• Eager to learn, interact cooperatively and effectively with others in a team environment
• Possess advanced word processing, data entry and data presentation computer skills
• Ability to influence and work effectively with business partners across regions and cultures
• Displays organizational leadership qualities and effective coaching abilities.
• Listening, interpreting, and summarizing information skills must be highly developed.
• Ability to work both independently with direction and within project teams to attain goals.
• Expertise in reviewing, revising, and writing Standard Operating Procedures (SOPs).
• Proven ability to manage projects/teams of significant scope and complexity, while meeting all deliverables and timelines.
• Strong organizational skills and the ability to participate effectively cross-functionally.
• Ability to build consensus among colleagues with an appropriate level of flexibility, while maintaining a focus on results and goal attainment.
• Fluency in written and spoken English. Fluency in Chinese is a plus.
• Demonstrated ability to lead on-site corporate, external, or Health Authority inspections
• A self-starter and a team player who thrives in a fast-paced dynamic team environment.
• Proficiency in using the Veeva suite of products and Microsoft Office applications required (MS Word, MS Excel, MS PowerPoint).
• Willingness to travel to various meetings, may include overnight trips. May require approximately 5-12% travel (closer to 12% for Remote candidates).

Corbus Culture:

Corbus is a close-knit team of high-achieving, innovative, creative and, above all else, passionate employees. We hire for personality as well as for skill. At Corbus, we take pride in our “family” atmosphere where each person’s contribution is vital to our success. As a Corbus employee, you are empowered to think creatively and be proactive in your approach. There is no place for politics or red tape here.

About Corbus:

Corbus Pharmaceuticals Holdings, Inc. is a clinical-stage company focused on oncology and obesity and is committed to helping people defeat serious illness by bringing innovative scientific approaches to well-understood biological pathways. Corbus is headquartered in Norwood, Massachusetts. For more information on Corbus, visit corbuspharma.com. Connect with us on X, LinkedIn and Facebook.

Corbus Pharmaceuticals Holdings, Inc. is an equal opportunity employer