Director, Global QARA Compliance, External Audit

Job Description

* Establishment of a Global Quality and Compliance organization.

* Completion of Global Quality and Regulatory transformation initiatives and organization goals.

* Development and implementation of global compliance audit program.

* Develop systems and processes to support global execution of the Quality system, specifically the development and implementation of Global External Audit Quality System policies, procedures, and programs.

* The focus will be over external audits of Global Quality System Processes, compliance with FDA 21 CFR, Part 820, ISO 13485, and all other applicable global regulatory requirements.

* Serves as the Global External Audit Quality System Process Steward, providing assurance of the effectiveness and continuous improvement of the Global External Audit Process and supporting programs.

* Quality Leader providing training and mentoring to the organization in all quality and compliance matters supporting the development of talent and competencies.

Job Duties

* Develops and implements the Global External Audit Quality System policies, procedures, and programs.  Designated as the Global External Audit Quality Systems Process Steward. 

* Development and implementation of Global audit readiness programs and tools that improve site audit readiness (compliance and audit support) and assesses likelihood of future audits.

* Development and implementation of a Global audit response process.  Establish process for management of all audit responses, responsibilities, timelines, templates, review / approval requirements, and ensures robust responses are delivered to all external authorities / agencies.  Drafts, reviews, and approves audit responses.

* Development and implementation of new monitoring and reporting tools that measure progress of external audit schedules and audit outcomes.  Identifies, accesses, and analyzes data that have impact on the company’s compliance to overall quality systems.  Tracks, trends, and analyzes external audit findings, corrective actions, and remidiations. Is able to make recommendations based on areas of highest compliance risk.

* Develop and deliver compliance monitoring scorecards and communications to Executive Leadership for real time reporting of external audit outcomes.

* Development and implementation of external audit training programs.

* Develops and implements a Global QMS Certification and Change Notification Process.  Establish Global process that ensures QMS certificates are maintained and change notifications are provided to applicable regulators and Notified Bodies. Enhances relationships with external authorities, supports QMS inventory development initiative, provides visibility and support for future certification efficiencies.

* Serves as an internal consultant by providing guidance and meaningful interpretations of applicable regulations to quality and clinical teams.

* Provides guidance and approval regarding quality strategies and approaches.

* Establish a dedicated team to implement Global External Audit Process and provide sites support for all audits, improving outcomes and efficiencies. Lead Global External Audit Support team, Global External Audit Communities of Practice, and Audit Readiness forums in process implementation and continuous improvement efforts.

Job Requirements

REQUIRED QUALIFICATIONS:

* Bachelor’s degree or equivalent.

* Minimum of 10 years related experience and in medical device industry.

* Requires background and strong familiarity with applicable regulatory requirements, including but not limited to U.S. FDA, EU MDD/MDR, ISO 13485, Health Canada, MHLW, ANVISA, and TGA.

* Experience in leading sites / organizations through US FDA, Notified Body, and other International Regulatory Agency Audits.

* Since this is a Global Role, the individual will be expected to schedule meetings that accommodate multiple time zones. Domestic and international travel up to 40 % of the time should be expected.

PREFERRED QUALIFICATIONS:

* Significant experience writing, reviewing, and providing feedback on audit responses, is highly valued.

* Experience in working collaboratively with external industry and regulatory partners.

* Experience with applicable Regulatory Agency or Authority is preferred.

* Leadership and interpersonal skills to develop and manage good working relationships with all Olympus locations and internal departments (R&D, Manufacturing, Supply Chain, Regulatory, Quality, Regulatory, etc…).

* Ability to work effectively in a fast paced and dynamic environment.

* Working knowledge of problem-solving skills good statistical and analytical skills. Proven success in driving cultural change.

* Proven Management and leadership skills; ability to lead and manage cross functional teams and develop talent.

* Strong written and verbal communication skills.

* Proficient in the use of Information Technology.