Vice President, QARA Compliance, Global

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

Principle Duties and Responsibilities

• 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.

Primary Objectives

• 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 and Internal Audit Action Plans
• Build dynamic risk assessment capabilities driven by data analysis.
• Track audit plan (actual vs. budget) and monitor against the risk assessment.
• Enhance Executive Reporting for overall function.
• Manages, coaches, and develops a high performing audit team that meets agreed objectives, and which on time results, added value and continuous improvements.
• Sets / delivers to department objectives/KPIs and reviews and assesses ongoing performance of direct reports as well as ‘dotted line’ reports in other regions (as may be required).
• Reports on achievement of targets and identifies any actions required.
• Single point of contact for review and comment on proposed External Regulatory Compliance proposed changes that affect Olympus.

Job Qualifications

Required:

• Minimum requirements are a BA/BS degree or equivalent.
• Minimum 15 years of experience in Audit Assurance within the medical device industry with 7 years of specific leadership and/or management experience.
• Ability to work effectively in a fast paced and dynamic environment.
• Leadership and interpersonal skills to develop and manage good working relationships with internal departments (R&D, Manufacturing, Supply Chain, Quality etc).
• Strong analytical skills, and the ability to analyze and identify trends and root causes.
• Very strong risk/auditor skills – critical to evaluate remediation of issues and management’s action plans.
• Excellent interpersonal and leadership skills with diverse cultural approach.
• A self-starter motivated and able to positively motivate others. Demonstrates the highest ethical standards, actively promotes trust, respect and integrity in all dealings both inside and outside Olympus.
• Focused, target driven with a positive, can-do attitude and a desire to improve patient experience as well as company performance.
• Excellent writing and verbal skills.
• Since this is a Global role, the individual will be expected to schedule meetings that work for multiple time zones and well as 40% travel should be expected. 

Preferred:

• Significant experience reviewing/providing feedback on audit work performed by others is highly valued.
• Regulatory Agency as Compliance Officer preferred.
• Strong written and verbal communication skills.Regulatory Agency as Compliance Officer preferred.