Position Summary

We are looking for a detail-oriented Process Manager who will be responsible for overseeing and improving our company's operational processes. In this position, you will analyze current processes, identify areas for improvement, and implement changes to increase efficiency and productivity. You will also be expected to work closely with cross-functional teams and develop strategies to optimize workflow. This role requires a strong understanding of project management methodologies, process mapping, and process improvement techniques, including effective use of AI to improve efficiencies and outcomes of process execution. The Process Manager should have excellent communication skills to effectively collaborate with cross-functional teams and stakeholders to manage change as process improvements and resulting trainings are adopted globally.

Essential Functions

• Global Process leader tasked with enhancing, maintaining, and optimizing a unified Global Solution Lifecycle Process for the company.
• Maintain key compliance, quality assurance and productivity metrics/KPIs. Produce monthly reports for senior leadership team.
• Leverage AI for Audit and Process Optimization, including:
• Utilize AI-powered tools for data analysis, anomaly detection, and predictive insights to improve audit accuracy and speed.
• Apply machine learning models to identify patterns, forecast risks, and prioritize audit areas.
• Integrate AI-driven dashboards and analytics into audit reporting for real-time visibility and actionable insights.
• Oversee software process validation and audit compliance in line with departmental SOPs and guidelines.
• Ensures SLP validation documentation content is complete, maintained and meets ISO 13485 requirements.
• Plan and conduct multiple concurrent internal audits, including reviews of cybersecurity, applications, technology infrastructure and process compliance. (Partnering with Global QA/RA)
• Authoring and/or contributing to all Quality deliverables including Plan, Requirements, Test Plan, Design, Protocols, Traceability Matrix, Baseline, Reports and Standard Operating Procedures (SOPs).
• Assesses the company’s quality processes and identifies any potential audit gaps.
• Leads Global Process Council of stakeholders to review, revise, and approve process change.
• Manages communication of change, training, and roll out of processes to global stakeholders.
• Propose and lead process improvement initiatives.
• Participates in global external regulatory audits and provides information on validation and compliance activities.
• Creates, maintains, distributes, and drives adherence to standardized templates, guidance, and overall validation direction supporting various programs.
• Reviews internal and external requirements and implements required processes as needed to meet expectations regarding Quality.

• Prepare high-quality working papers to support audit conclusions and recommendations within defined deadlines.
• Bachelor's degree in Business Administration, Computer Science, Engineering, or a related field required. Master's degree in Business Administration or a related field is preferred.
• None

• All other SLP, SDLC, Audit and Quality processes and tasks as needed.

Qualifications

• Strong Program and Project Management skills, professional certification is preferred.
• Direct experience (3) years optimizing business and software processes through Lean and Six Sigma methodologies. Certified Six Sigma Black Belt is preferred.
• Over Five (5) years related experience in Software Quality Control or SDLC or Validation in a medical, clinical, pharmaceutical, or analytical setting.
• Proven experience (5 years) with planning, execution, and reporting of complex Audits for a variety of Web Applications, Databases, Operating Systems, Networks, Servers, and Technology Infrastructure.
• Strong understanding of solution lifecycle management and technology governance
• Familiarity with AI tools and techniques (predictive analytics, NLP, automation)
• Knowledge and understanding of audit methodologies and tools that support audit processes.
• Excellent verbal, written, and interpersonal communication skills.
• Ability to collaborate and effectively communicate at all levels throughout the organization.
• Proven experience leading and providing feedback to staff and senior leadership on audit projects or engagements.
• Experience with IS0 13485, FDA, GxP, Part 11 validation rules and other global product regulations.
• Ability to travel to product development sites to support all quality and regulatory issues as required.

Supervisory Responsibilities