|
Summary:
|
|
The Supervisor – Quality Management System (QMS) ensures compliance with Hollister’s Quality System and departmental procedures by managing direct reports and supporting key QMS functions. This role combines supervision, project oversight, software validation, and analytics excellence to drive global quality and continuous improvement. The Supervisor will assist GQRA sub-verticals (Data Analytics, QMS Software Validation, CAPA) with project assignments and prioritization, manage team performance, provide guidance, and ensure adherence to QMS standards while collaborating across time zones with global cross-functional teams to meet project deadlines.
In addition, the Supervisor acts as the quality representative/SME for GMP-compliant computer system validations, developing and executing validation plans, protocols, and documentation for global software systems. The role also leads to change control and process improvement initiatives, assists with budgeting and resource planning, and oversee a centralized analytics capability to enable smarter decisions, strengthen compliance, and ensure accuracy of GQRA data analytics deliverables.
|
|
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.
- Flexibility: Adaptable to changing priorities and global collaboration requirements.
|
|
Work Experience Requirements
|
- Number of Overall Years Necessary: 8-12
- 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.
|
