- Full-time
- Sets the standards and programs in order to conduct effective and efficient audits globally in a consistent manner, based on the policy of the global quality assurance division and regulatory trends. Set an audit program or plan to assure the reliability of the operations of the audited department, and to improve their operations
- Scope involves the research development, manufacturing and distribution of quality-audit-related activities of pharmaceutical and medical devices products
- Ensures the design and implementation of the appropriate Quality Management Systems by audit is in compliance with the GxP and other applicable regulations in Santen territories
- Has oversight of GxP audit activities regionally and globally
- Build consensus and collaborate effectively with cross regional quality functions to deploy and manage quality assurance strategies and initiatives
- Establish, improve and maintain quality systems for GxP audit and procedures to meet legal requirements and guidelines including CSV
- Set-up necessary audit related SOPs and conduct regular SOP reviews and product quality reviews
- Establish and monitor quality strategies to achieve quality goals for GxP audit
- Collect, review the regional audit activities and provide feedback or guidance
- Build 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 global GxP audit function and develop this organization to implement a standardized GxP audit function
- Minimum master's degree (MSc) or PhD (of advantage)
- Demonstrates in-depth knowledge of QA principles, concepts, industry practices, and standards
- Demonstrates in-depth knowledge of regulatory requirements (GLP, GCP, GVP, GMP, GDP, etc.)
- Over 15 years' experience in Pharmaceutical QA
- Experience with development products, sterile products and medical devices is mandatory
- 15+ years of experience in a quality assurance function with prior people management experience
- Successful experience of managing a multi –national team
- Working knowledge of Risk Management tools HACCP or FMEA
- Demonstrates excellent verbal, written and interpersonal communication skills
- Must be goal-oriented and quality-focused with good business acumen
- Can handle conflicts by quickly finding common ground and get cross-functional cooperation to achieve resolution
- Excellent English Language skills
- Demonstrates understanding of Computer Systems Validation and ICH Guidelines
- Demonstrates knowledge of Six Sigma, performance measures and quality improvement
- Knowledge of ophthalmology is a plus
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General Manager, Quality Compliance Audit Group - Osaka, 日本 - Santen Inc
説明
[GLOBAL] General Manager, Quality Compliance Audit Group
Company Description
Santen is a specialized life sciences company with a proud 130-year heritage focused exclusively on ophthalmology. As a Japan-originated, global company with our footprint in over 60 countries, we are dedicated to delivering innovative treatments and digital solutions for eye health and addressing vision-related social issues for people around the world.
PURPOSE OF ROLE
Job Description
Qualifications
EDUCATION
Essential
Desirable
EXPERIENCE
Essential
Desirable
FUNCTIONAL COMPETENCIES
Essential
Desirable
Additional Information
Grow your career at Santen
A career at Santen is an opportunity to make a difference. Through our long-term vision outlined in Santen 2030, we are committed to be a Social Innovator - addressing the social and economic needs of people with visual impairments. We have team members around the world using their diverse talents to unlock new modalities and drive innovations for patient outcomes, education and treatment. At Santen, we believe in empowering all our team members with flexible ways of working and a highly inclusive work environment.
The Santen Group is an Equal Opportunity Employer. We are committed to building diverse teams and ensuring a safe and inclusive physical and virtual workplace for every one of our team members. All employment decisions are based on business needs, role requirements and individual qualifications regardless of race, color, ethnicity, national origin/ancestry, religion, sexual orientation, gender, gender identity/ expression, age, disability, medical condition, marital status, veteran status, or any other characteristic protected by law.
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