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Olympus Corporation · 11 hours ago

Vice President, QARA Compliance, Global

Center Valley, PA

Full-time

Hybrid

Director/Executive

$201K/yr - $322K/yr

15+ years exp

Olympus Corporation is a global medical technology company dedicated to improving lives through innovative solutions. They are seeking a Global Vice President of QARA Compliance to oversee regulatory compliance, implement quality systems, and manage audit programs to ensure adherence to global standards and regulations.

ElectronicsIndustrialManufacturingMedical DeviceProduct Design

Responsibilities

Global Audit Planning for Internal and External Audit Activities

Review and Approve all Official Audit Responses to External Regulatory Authorities

Improving Efficiency in Audit Execution and Reporting to Executive Management

Accelerating Talent Development

Driving Risk Based Assurance and Monitoring utilizing data

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 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

Qualification

Regulatory ComplianceAudit AssuranceQuality Management SystemsRisk AssessmentAnalytical SkillsSupplier QualificationLeadership ExperienceInterpersonal SkillsCommunication SkillsTeam Management

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