As Manager QA Compliance, you will play a pivotal role in ensuring compliance with global Manufacturing Authorization Holder (MAH) and Sponsor responsibilities. You will oversee the process landscape and global MAH/Sponsor Quality Management System (QMS) footprint, ensuring adherence to GMP and regulatory standards.
You will act as Manager QA Compliance with a focus on GMP and regulatory processes to fulfill MAH/Sponsor responsibilities. This includes designing, maintaining, and optimizing the process landscape to ensure compliance and operational excellence.
You will support discussions and decision-making processes with strategic partners on complex GMP and compliance matters. This involves coordinating and preparing comprehensive information, as well as organizing and supporting Quality forums and committees to drive alignment and collaboration.
Your role includes ensuring effective communication, advising and supporting peers, and networking to achieve company goals while maintaining compliance.
You will ensure regional compliance as a MAH/Sponsor representative, addressing evolving regulatory requirements.
You will implement MAH/Sponsor Board processes, ensuring effective evaluation of quality metrics, trends, and compliance data to drive informed decision-making and continuous improvement initiatives.
You will proactively maintain and report related metrics, identifying and mitigating risks to ensure compliance and operational efficiency.
You will support inspections and audits related to MAH/Sponsor responsibilities, including preparation, coordination, and follow-up activities. MSc, PhD) are a plus.
Extensive experience (5+ years) in Quality Assurance, GMP compliance, and regulatory processes within the pharmaceutical industry.
Excellent written and verbal communication skills in English.
Analytical mindset with the ability to navigate complex compliance challenges and drive solutions.
Your Benefits:
Digital Learning | Performance & talent development | leadership development | Apprenticeships | LinkedIn Learning
Job ticket | Deutschlandticket
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