Work Flexibility: Remote or Hybrid or Onsite
The Director, Global Quality, Regulatory & Clinicals (GQRC) is a technology leader responsible for defining and executing the technology strategy, roadmap, and delivery portfolio that supports regulated product development, compliance, quality operations, clinical execution, regulatory submissions, and labeling processes across Global Quality Operations (GQO). This role owns the end-to-end lifecycle of Product Lifecycle Management (PLM), Quality, Regulatory, Clinical, and Labeling technology platforms, ensuring solutions are scalable, secure, reliable, and aligned with business priorities.
This Director leads cross-functional products, engineering, solution architecture, and delivery teams while partnering closely with R&D, Quality, Regulatory Affairs, Clinical, Labeling leaders. The role translates business needs into executable technology plans, drives process standardization, automation, and digital transformation, manage vendor and partner relationships, and strengthens operational performance.
Key responsibilities include:- Key responsibilities include:
- Define and execute a multi-year roadmap for PLM, Quality, Regulatory, Clinical, Product Labeling, and related GQRC platforms, ensuring alignment with business priorities, regulatory expectations, and enterprise architecture standards.
- Lead products, platforms, engineering, solution architects, and delivery teams supporting GQRC solutions across global and matrixed environments.
- Partner with senior leaders across R&D, Quality, Regulatory Affairs, Clinical, and Labeling to align technology investments with operational objectives and measurable business outcomes.
- Establish product and platform strategies that improve regulatory compliance, , operational efficiency, quality, and business outcomes.
- Provide leadership for global technology deployments, including solution design, process alignment, integration strategy, validation readiness, change adoption, cutover planning, post-go-live stabilization, and value realization.
- Apply fit-for-purpose delivery methodologies, including Agile, SAFe, hybrid, and Waterfall approaches, to ensure governance, execution discipline, and delivery practices are matched to program complexity, regulatory needs, and business outcomes.
- Drive platform enhancements, integrations, upgrades, modernization, simplification, and continuous improvement across PLM, labeling, clinical, quality, regulatory, laboratory, and related regulated technology capabilities.
- Ensure platforms and solutions operate in alignment with enterprise architecture, cybersecurity, privacy, compliance, computer system validation, audit readiness, quality management system expectations, and applicable MedTech requirements, including FDA and ISO standards.
- Govern prioritization, investment decisions, demand management, and delivery planning across the GQRC technology portfolio.
- Identify opportunities to simplify processes, automate workflows, standardize operations, and improve operational effectiveness through technology.
- Establish engineering, delivery, and platform management standards that improve quality, reliability, scalability, and speed of execution.
- Serve as a senior technology leader and trusted advisor for platforms such as PTC Windchill, Loftware Cloud, TrackWise, LabVantage, Medidata, and related enterprise solutions supporting product development and regulated operations.
- Manage strategic vendor, implementation partner, and consultant relationships, including selection, contracting support, performance oversight, issue resolution, and accountability for quality deliverables.
- Develop and monitor KPIs measuring platform adoption, operational performance, delivery effectiveness, system reliability, and value realization.
- Collaborate with Enterprise Architecture, Cybersecurity, Infrastructure, Data, Integration, Program Enablement, and Governance teams to ensure solutions are secure, supportable, integrated, and aligned with enterprise technology direction.
- Stay current on industry trends, regulatory expectations, and technology advancements, and apply those insights to improve the platform roadmap, delivery practices, operating model, and long-term business value.
Qualifications & experience:- Bachelor's degree in computer science, Information Technology, Engineering, Business, or a related field required; master's degree preferred.
- Minimum of 12-15+ years of progressive experience in Information Technology, enterprise application delivery, digital transformation, or related technology leadership roles, including people leadership responsibility.
- 10+ years of experience leading large, complex technology programs or platform deployments supporting R&D, Product Lifecycle Management, Quality, Regulatory, Clinical, Product Labeling, or related regulated business processes.
- Demonstrated experience defining technology roadmaps, managing delivery portfolios, governing investment priorities, and partnering with senior business stakeholders to deliver measurable business outcomes.
- Extensive platform knowledge across PLM, Product Labeling, Quality Management, LIMS, Regulatory, and Clinical technologies, with a proven track record of delivering enterprise-scale programs.
- Preferred experience with platforms such as PTC Windchill, Loftware Cloud, TrackWise, LabVantage, Medidata, and similar enterprise technology solutions.
- Preferred knowledge of integrating PLM, Quality, Regulatory, Clinical, Labeling, and related platforms with ERP systems such as SAP S/4HANA, SAP ECC, Oracle E-Business Suite, and JD Edwards.
- Strong understanding of regulated system delivery, including computer system validation, data integrity, quality system expectations, audit readiness, and compliance with applicable MedTech, FDA, ISO, and related regulatory guidelines.
- Demonstrated knowledge of Agile, SAFe, hybrid, and Waterfall delivery methodologies, with the ability to apply the right approach based on business priority, solution complexity, compliance requirements, and delivery risk.
- Excellent leadership, executive communication, and influencing skills, with the ability to align stakeholders, manage ambiguity, and drive decisions in a global matrix organization.
- Strong analytical and problem-solving skills, with a strategic mindset and demonstrated ability to translate business needs into executable technology plans.
- Experience managing strategic vendors and implementation partners, including vendor selection, contracting support, performance oversight, and delivery accountability.
- Ability to understand emerging trends, future-state business needs, and enterprise architecture direction, and convert them into practical programs that improve capability, compliance, and business value.
- Demonstrated ability to translate operational priorities into scalable technology strategies and delivery plans
- Ability to manage multiple strategic initiatives and competing priorities simultaneously
- Strong leadership, interpersonal, analytical, change management, and executive communication skills.
- Ability to work effectively across functions, geographies, business units, and technology teams while building trusted relationships in a global matrix organization.
- Ability to understand systems, business processes, integrations, dependencies, and organizational impacts, and recommend practical improvements.
United States of America Pay Ranges:- USN: $155,900 - $259,700 USD Annual
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Travel Percentage: 30%
