General Manager, Quality Compliance Audit Group

19時間前

Osaka Santen Inc Full time

Global Manager, Quality Compliance Audit Group

The Santen Company, a specialized life sciences company with 130 years of history, focuses on ophthalmology. As a Japan-originated company with over 60 countries' presence, Santen delivers innovative treatments and digital solutions for eye health worldwide.

Purpose of the Role

  • Set global audit standards and programs to conduct consistent audits based on regulatory trends and quality assurance policies.
  • Develop an audit program to ensure department operations' reliability and improvement.
  • Research, development, manufacturing, and distribution of quality-audit-related pharmaceutical and medical device activities are within scope.
  • Ensure compliance with GxP and other applicable regulations in Santen territories through Quality Management Systems by audit design and implementation.
  • Oversight of GxP audit activities regionally and globally.

Job Description

  • Collaborate effectively with cross-regional quality functions to deploy quality assurance strategies and initiatives.
  • Establish, improve, and maintain quality systems for GxP audit and procedures to meet legal requirements and guidelines, including CSV.
  • Create necessary audit-related SOPs, conduct regular SOP reviews, and product quality reviews.
  • Establish and monitor quality strategies to achieve quality goals for GxP audit.
  • Collect and review regional audit activities, providing feedback or guidance.
  • Foster good relationships with R&D functions, safety vigilance functions, manufacturers, distributors, regulators, business partners, raw material suppliers, etc.
  • Complete domestic and international audit compliance tasks (authorities, recipients, contractors) and CAPAs.
  • Provide guidance and hands-on support to internal functions for CAPA development and tracking.
  • Hire, train, and develop quality department personnel as a managerial position.
  • Manage the global GxP audit function and develop this organization to implement a standardized GxP audit function.

Qualifications

Education

  • Mandatory: Master's degree (MSc) or PhD.
  • Demonstrate in-depth knowledge of QA principles, concepts, industry practices, and standards.
  • Demonstrate in-depth knowledge of regulatory requirements (GLP, GCP, GVP, GMP, GDP, etc.).

Experience

  • Mandatory: Experience with development products, sterile products, and medical devices.
  • 15+ years of experience in a quality assurance function with prior people management experience.
  • Successful experience managing a multinational team.

Functional Competencies

  • Excellent verbal, written, and interpersonal communication skills.
  • Goal-oriented and quality-focused with good business acumen.
  • Conflict resolution by finding common ground and achieving cooperation among cross-functional teams.
  • Excellent English language skills.

Additional Information

Grow Your Career at Santen

A career at Santen is an opportunity to make a difference. We are committed to addressing social and economic needs through our long-term vision outlined in Santen 2030. Our diverse talents aim to unlock new modalities and drive innovations for patient outcomes, education, and treatment.

The Santen Group is an Equal Opportunity Employer. We value diversity and ensure a safe and inclusive physical and virtual workplace for every team member. Employment decisions are based on individual qualifications, role requirements, and business needs regardless of protected characteristics.

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