Quality Management System Lead

Quality Management System Lead

Description -

We are seeking an experienced Quality Management System (QMS) Lead to drive the development, implementation, and sustainability of a robust QMS. This role will support the product development lifecycle and future EUPIA/GMP manufacturing requirements across various technology platforms & work centers.

This is an expert‑level, highly visible role that requires deep systems expertise, strong cross‑functional leadership, and the ability to influence priorities and behaviors to move the organization toward a documented, trained, and continuously improving system.  This role will ensure that quality is embedded into everyday behaviors and processes and that the QMS is a practical and useful tool.

Responsibilities

QMS Development & Ownership

• Own the overall QMS strategy and roadmap. Lead the development, rollout, and sustainment of QMS modules aligned to ISO 9001 and EUPIA/GMP requirements (e.g., CAPA, audits, change management, training, document control, records management, process control).
• Define the QMS framework and tiered documentation structure (policies, procedures, records), ensuring consistency and scalability across programs and organizations.
• Ensure QMS modules support both product development and manufacturing readiness.
• As required, develop and own QMS modules and systems before handing off to long-term owners.
• Work with management to identify and resolve resource needs associated with QMS.
• Serve as the subject matter expert on quality system standards and interpretations
• Align the QMS with adjacent organizations.  Serve as a resource for other QMS efforts. 

Implementation & Adoption

• Partner with engineering, operations, and program leadership to embed QMS requirements into existing workflows.
• Support rollout of QMS practices into new areas beyond initial pilot groups.
• Reinforce behaviors through audits, metrics, and management reviews—not documentation alone.
• Ensure that the QMS efforts focus on usefulness and not check-the-box compliance. 

Metrics, Reviews & Continuous Improvement

• Define, track and integrate QMS-related metrics to existing meetings and review systems
• Lead & support QMS management reviews and executive sponsor updates.
• Identify systemic gaps and drive continuous improvement across processes and systems.

Required Qualifications and/or Experiences

• Bachelor’s degree in Engineering, Quality, Manufacturing, or related field (or equivalent experience).
• Previous experience building, implementing, and/or sustaining Quality Management Systems in an R&D and/or manufacturing environment.
• Working knowledge of ISO 9001; familiarity with EUPIA/GMP, GMP, or other regulated quality systems (medical, pharma, food, or similar).
•  Experience with CAPA systems, internal audits, and document control.
• Understanding of product development processes, control plans and change management systems.

Preferred Experience and Skills

• Ability to translate standards and regulatory language into clear, usable processes.
• Strong systems thinking — able to see interactions between systems, metrics, and behaviors.

• Strong understanding of Project Management Fundamentals, SPC & manufacturing processes.
• Excellent verbal and written communication skills, with the ability to influence at all levels of the organization without authority.
• Experienced with working with partners across all levels – including, but not limited to: operations, engineers, management, and Southeast Asia.
• Project and program leadership skills; able to drive progress across multiple parallel efforts.
• Comfortable working through ambiguity and evolving requirements
• Prior experience supporting audits & certification
• Experience with tiered documentation frameworks.
• Familiarity with document management system (e.g. DMS) and electronic change management tools (e.g., Windchill).
• Previous Product/Quality Engineering experiences

The pay range for this role is $116,150 to $182,400 USD annually with additional opportunities for pay in the form of bonus and/or equity (applies to United States of America candidates only). Pay varies by work location, job-related knowledge, skills, and experience.

Benefits:

HP offers a comprehensive benefits package for this position, including:

• Health insurance
• Dental insurance
• Vision insurance
• Long term/short term disability insurance
• Emp