Director, Enterprise Digital & Technology Build Lead – GQRC

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:

• Bachelors degree in computer science Information Technology Engineering Business or a related field required; masters degree preferred.
• Minimum of 1215 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: $155900 - $259700 USD Annual

View the U.S. work location and transparency guide to find the pay range for your location.

Travel Percentage: 30%

Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race ethnicity color religion sex gender identity sexual orientation national origin disability or protected veteran status. Stryker is an EO employer M/F/Veteran/Disability.

Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about discussed or disclosed their own pay or the pay of another employee or applicant. However employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information unless the disclosure is (a) in response to a formal complaint or charge (b) in furtherance of an investigation proceeding hearing or action including an investigation conducted by the employer or (c) consistent with the contractors legal duty to furnish information.