Global Vice President QARA Compliance

Working Location: MASSACHUSETTS, WESTBOROUGH 

Workplace Flexibility: Field

Are you looking for a company that cares about people’s lives and health, including yours? Let’s inspire healthier lives, together.

 

Olympus, a leading medical technology company, has focused on making people’s lives better for over 100 years.

Our Purpose is to make people’s lives healthier, safer, and more fulfilling.

 

Our Core Values are reflected in all we do: Integrity – Empathy – Agility – Unity – Long-Term View

 

We deliver on our purpose and our core values by staying True to Life.

Job Description

The Global Vice President QARA Compliance provides assurance and manages all aspects of Regulatory Compliance. The focus will be over the implementation of the Global Quality Systems Processes, compliance with FDA CFR, Part 820, Quality System Regulation and ISO 13485 and all other applicable global regulatory requirements.

 

The Global Vice President QARA Compliance is responsible for executing a global compliance audit program of the quality management system, providing assurance of the effectiveness of the Quality and Compliance of the organization, which is designed to meet appropriate division, Olympus, government, and international standards/regulations for efficacy, safety, quality and compliance for the design, manufacture, and service of clinical and research products.

 

Primary Responsibilities

The Global Vice President QARA Compliance will focus on five primary areas that will influence how the functional vision and implementation plans align to the business strategic imperatives and global function mission.

1. Global Audit Planning for Internal and External Audit Activities

2. Review and Approve all Official Audit Responses to External Regulatory Authorities

3. Improving Efficiency in Audit Execution and Reporting to Executive Management

4. Accelerating Talent Development

5. Driving Risk Based Assurance and Monitoring utilizing data

Job Duties

• Thinks “Out of the Box” to optimize Corporate Quality goals and business value & plans, directs resources and activities with Corporate Quality.
• Develops and implements global compliance strategies, oversees all aspects of risk assessment development.
• Ensures alignment of compliance activities to business activities with global a focus on Growth, Innovation, and Operational Effectiveness across all functional areas.
• Execute global internal audit activities for the Quality Assurance and Regulatory Affairs Function and tracks and coordinates audit corrective actions and remediations.
• Administer and manage supplier qualification activities and monitor suppliers’ performance and provide recommendations.
• Coordinates and leads audit activities with all global regulatory agencies (e.g. FDA, Notified Bodies, PMDA, NMPA etc.)
• Creates and maintains Compliance department internal methodology and procedures that comply with applicable domestic and international regulatory laws/standards and all developed Olympus policies and procedures.
• Mentors, manages, and develops direct reports.
• Develop and deliver Compliance monitoring scorecards to Executive Leaders for real time reporting on Quality Management System
• Mentors, manages, and develops direct reports. Trains key personnel on quality policies, processes, and SOPs.
• Provides strategic leadership for all audit activities and agency inspections in the Americas, EMEA, Asia and globally.
• Fosters a strong relationship, partnership with business partners and global regulatory authorities through inspection readiness activities.
• Develops and manages Global Compliance Fiscal Year Budgets.
• Provides strategic and tactical direction to drive cross-functional consistency in audit methodology and approach.
• Establish processes to bring together global teams with embedded auditors, including offshored or co-sourced providers, to provide a consistent, value-added approach to audit and quality risk management.
• Review and Approve all External Audit Responses