Summary: Sets standards and programs for effective and efficient audits globally, ensuring consistency with regulatory trends and improving operations.
- Researches, develops, and implements quality-audit-related activities for pharmaceutical and medical devices products.
- Ensures Quality Management Systems compliance with GxP and other regulations.
- Has oversight of GxP audit activities regionally and globally.
Key Responsibilities:
- Collaborates with cross-regional quality functions to deploy and manage quality assurance strategies.
- Establishes and maintains quality systems for GxP audit and procedures.
- Set-up necessary audit-related SOPs and conducts regular reviews.
- Collects and reviews regional audit activities and provides feedback.
- Built relationships with R&D functions, manufacturers, distributors, regulators, and business partners.
- Completes audit compliance tasks and CAPAs.
- Provides guidance and hands-on support to internal functions.
- Hires, trains, and develops quality department personnel.
Qualifications:
- Master's degree or PhD in a relevant field.
- Minimum 15 years of experience in Pharmaceutical QA, with prior people management experience.
- Experience in development products, sterile products, and medical devices.
Functional Competencies:
- Excellent verbal, written, and interpersonal communication skills.
- Goal-oriented and quality-focused with good business acumen.
- Conflict resolution and cross-functional cooperation.
- Excellent English Language skills.
Santen is an Equal Opportunity Employer, committed to building diverse teams and ensuring a safe and inclusive workplace for all team members.
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