Quality Manager

Quality Manager

Overhaul is a rapidly growing software company specializing in in-transit supply chain visibility and risk management solutions for global enterprise organizations. Our cutting-edge technology empowers organizations to gain real-time insights into their supply chain operations, mitigate risks, and optimize their logistics processes.

As a Quality Manager, you will be responsible for establishing, implementing, and ensuring continuous improvement of the organization's Quality Management System (QMS). This role provides strategic leadership, operational oversight, and cross-functional coordination to ensure compliance with applicable standards, regulatory requirements, and internal business governance.

In this role, you will drive key initiatives through engagement with internal and external partners to meet strategic objectives and targeted outcomes. You will lead the formation of workstreams to ensure process simplification, adoption, and operationalization, while establishing metrics to measure performance and ensure continuous improvement.

Key Responsibilities

QMS Leadership & Strategy

• Build and mentor a high-performing quality team to ensure effective ownership and execution of the QMS.
• Develop and execute the organization's QMS strategy, roadmap, and governance model, inclusive of the evaluation and implementation of an eQMS system.
• Collaborate with partners to architect scalable, audit-ready frameworks, including document control, training, CAPA, risk management, internal and external audits, and management review.
• Ensure alignment of QMS activities with organizational goals, customer requirements, and regulatory expectations.
• Lead internal communication strategies to promote quality culture, process adoption, and organizational alignment.

Quality Governance, Risk Management & Compliance

• Maintain compliance with ISO 9001 and other relevant standards or regulations.
• Establish quality objectives, KPIs, and monitoring mechanisms to measure system and process performance.
• Oversee internal and external audits, ensuring findings are addressed through effective corrective and preventive actions.
• Develop and oversee the supplier evaluation and performance monitoring program, ensuring criteria, risk ratings, and approval status are maintained.
• Manage external communications with customers, auditors, and regulatory bodies regarding quality matters.

Cross Functional Collaboration

• Work with Product, Engineering, Operations, Customer Support, and other teams to embed quality practices into daily operations.
• Facilitate cross-functional problem-solving, root cause analysis, and continuous improvement initiatives.
• Provide guidance and coaching to process owners to ensure QMS adoption and accountability.

Continuous Improvement

• Drive a culture of quality, operational excellence, and proactive risk management.
• Identify opportunities to streamline processes, reduce waste, and improve system maturity.
• Leverage data, metrics, and audit insights to guide improvement initiatives.

Documentation & Process Control

• Oversee the creation, approval, revision, and retention of controlled documents.
• Ensure documentation is consistent, traceable, and aligned with QMS architecture.
• Develop templates, workflows, and document governance structures.

Training & Change Management

• Develop and deliver QMS training programs to ensure organizational understanding and compliance.
• Lead change management efforts related to new products, processes, tools, and quality initiatives.
• Ensure employees understand their roles in maintaining quality and compliance.

Basic Qualifications

• Bachelor's Degree in a relevant field (Quality, Engineering, Life Sciences, Operations Management, Business or similar)
• 5+ years of experience in Quality Assurance working with Pharma, Life Sciences and/or Biotech
• 5+ years of experience leading global teams
• Demonstrated experience managing an ISO 9001 aligned QMS

Preferred Qualifications

• Master's degree addressing strategic planning (Quality, Operations, Technology or similar)
• Knowledge of GxP, ISO 9001, 21 CFR Part 11, EU Annex 11, ISO/IEC 17025
• Experience in cold chain / supply chain monitoring or medical device industries
• Experience with implementing and managing eQMS systems
• Experience with validating software and hardware systems for support of regulated environments
• Strong organization skills, with ability to lead multiple initiatives
• Strong team leadership and communication skills
• Strong problem solving and analytical skills
• Experience collaborating with external partners
• Experience in SaaS solutions or technology driven environments

Other requirements

• Ability to travel up to 10% (domestic and international)

What we can offer:

• Competitive starting base salary
• Progressive advancement opportunity and career mobility
• Top employee health and well-being benefits
• Rotating company 'Perks at work' program
• Employee Assistance Program
• Care giver/adoption/family leave
• Flexible Time Off Policy
• Flexible working
• Free parking

Our culture

We are guided by our core values of Diversity and Synergy, Creativity, Problem Solving, Authenticity and Receptivity, Trust, Encouragement, Teaching and Learning, Wellness and Integrity. These values help us recruit aligned talent to join our rapidly expanding team around the globe. It is important to us that each and every Overhauler is not only eager to challenge themselves and knows how to get work done, but is also an awesome addition to our company culture.