Responsibilities: Manage and coach direct reports; oversee performance and professional development.
Working closely and collaborating with global business partners across diverse domains to align priorities with global standards and strategic objectives. Quality Management Compliance: Drive QMS activities and deliverables using project management expertise. Ensure compliance with Hollister QMS, FDA, cGMP, and GAMP standards. Support GQRA sub-verticals: Data Analytics, Software Validation, and CAPA. Software Validation (SME Role): Act as quality representative/SME for GMP-compliant system validations. Develop, review, and approve validation plans, protocols, and reports. Lead change control and process improvement initiatives to maintain data integrity. Support software validation team during internal/external audits and QMS reviews. Analytics Resource Planning: Oversee centralized analytics capability; ensure accuracy and integrity of deliverables. Drive analytics strategy and manage resources effectively. Assist with budgeting and resource planning for QMS sub verticals. Governance Training: Coordinate updates to procedures/forms and provide training for new hires and cross-functional teams. Maintain global software systems and ensure qualification of computerized applications.
Essential Functions of the Role**:
Communication: Exceptional verbal and written communication skills to convey complex information clearly and effectively. Attention to Detail: High level of accuracy and compliance with procedures; strong focus on right-first-time execution. Quality Commitment: Total dedication to maintaining high standards and ensuring Regulatory compliance. Supervisor: Ability to lead team, influence change, manage performance of multiple direct reports. Project Management: Strong organizational and planning skills; capable of managing multiple projects and priorities simultaneously. Problem-Solving Critical Thinking: Analytical mindset with ability to identify issues, propose solutions, and achieve project goals. Collaboration: Skilled at working with diverse teams across cultures, languages, and time zones to accomplish objectives. Results Orientation: Driven to meet business objectives targets and deliverables within deadlines. Independence: Ability to work remotely with minimal supervision and make informed decisions. Technical Proficiency: Familiarity with computer systems, spreadsheets, and accessories; experience in regulated environments and software validation. Adaptable to changing priorities and global collaboration requirements.
Work Experience Requirements
Number of Overall Years Necessary: 8 to 12 - Hands-on experience with computer systems and software validation.
- Strong understanding of applicable regulations, including Annex 11, GAMP, and 21 CFR Part 11.
- Proven expertise in computer systems and spreadsheet validation.
- Experience in regulated environments; medical device industry highly desirable.
- Previous people management experience (direct or indirect).
- Exposure to Medical Device GQRA Analytics.
- Data management experience.
Education Requirements
- Bachelor s Degree in a scientific or engineering discipline preferred, or associate s degree with equivalent management experience.
- Data Analytics Power BI Experience.
Specialized Skills/Technical Knowledge:
- Regulatory Knowledge: Strong understanding of medical device quality and regulatory requirements, including ISO 13485, GAMP 5, IEC 62304, 21 CFR Part 820, Part 11, and Computer System Validation processes.
- Software Validation Proven experience implementing software validation methodologies; skilled in reviewing, evaluating, and testing systems for compliance with FDA Electronic Records/Electronic Signatures regulations.
- IT Systems Testing Solid knowledge of IT infrastructure and applications; hands-on experience testing GAMP Category 3, 4 5 systems.
- Audit Readiness: Experience interacting with auditors and ensuring compliance during inspections.
- Communication Collaboration Excellent oral and written communication skills; ability to work effectively across all organizational levels and diverse cultural backgrounds.
- Resource Planning: Assist with budgeting and resource estimation for QMS verticals.
- Analytics Excellence: Oversee centralized analytics capability; drive strategy, manage resources, review performance, and ensure accuracy of GQRA data analytics deliverables.
- Results Orientation: Strong ability to prioritize tasks, manage deliverables, and meet project targets under strict timelines.
