Act as Manager QA Compliance with a focus on GMP and regulatory processes
Oversee the process landscape and global MAH/Sponsor Quality Management System (QMS) footprint
Ensure adherence to GMP and regulatory standards
Design, maintain, and optimize the process landscape to ensure compliance and operational excellence
Support discussions and decision-making processes with strategic partners on complex GMP and compliance matters
Provide clear guidance to stakeholders, fostering a strong Quality mindset across the organization
Contribute to the ongoing improvement of the pharmaceutical quality system
Ensure regional compliance as a MAH/Sponsor representative
Implement MAH/Sponsor Board processes, ensuring effective evaluation of quality metrics, trends, and compliance data
Proactively maintain and report related metrics, identifying and mitigating risks to ensure compliance and operational efficiency
Support inspections and audits related to MAH/Sponsor responsibilities

Degree in Pharmacy, Chemistry, Biology, or a related scientific field
Advanced degrees (e.g., MSc, PhD) are a plus
Extensive experience (5+ years) in Quality Assurance, GMP compliance, and regulatory processes within the pharmaceutical industry
Proven track record of managing MAH/Sponsor responsibilities and QMS frameworks
Strong knowledge of GMP guidelines, ICH Q10, and regional/national regulatory requirements
Exceptional communication and networking skills to foster collaboration across teams and stakeholders
Excellent written and verbal communication skills in English
Analytical mindset with the ability to navigate complex compliance challenges and drive solutions

QA Compliance Manager

Key skills