Senior GMP Quality System Manager

Company Description

At Sobi, each person brings their unique talents to work as a team and make a difference. We are dedicated to developing and delivering innovative therapies to improve the lives of people who live with a rare disease. Our edge comes from our team of people and our commitment to patients.

Job Description

The Senior GMP Quality System Manager plays a pivotal role in ensuring the effectiveness of a robust Quality Management System (QMS). This position facilitates efficient, compliant, and agile quality process adaptation aligned with business priorities and regulatory requirements. The Senior Manager is tasked with developing, implementing, harmonizing, and continuously enhancing quality systems across global manufacturing and supply chain operations to ensure compliance with current GMP regulations, internal standards, and industry best practices. Additionally, this role leads and supports improvement initiatives within their area of responsibility, thereby maintaining control over the Sobi QMS.

QMS Development, Performance and governance

• Develop, implement, and maintain an agile QMS framework in alignment with company’s strategy and Global Quality Mission
• Facilitate the development and integration of GMP aspects and Quality Risk Management within Sobi’s strategy for the acquisition of new companies and products into the Sobi QMS.
• Lead global harmonization initiatives within the area of responsibility, collaborating with respective quality oversights to ensure consistency across external contract manufacturing organizations.
• Monitor and analyze global GMP performance metrics derived from QMR and monthly KPI meetings); identify trends, process performance gaps, and drive continuous improvement.
• Ensure that principles of continuous improvement are consistently developed and applied within all GMP areas.
• Lead and support continual improvement activities to maintain regulatory compliance and enhance the performance of Sobi’s QMS, focusing on standardization, simplification, proactivity and efficiency.
• Lead and participate in global quality system projects and enhancement initiaties. Advocate for a culture of quality adherence to regulations and continuous improvements.

Regulatory Compliance & Inspection Readiness

• Collaborate with the quality oversight of external manufacturing organizations to ensure all (virtual) plants maintain a state of inspection readiness.
• Offer GMP expertise during internal and external audits and inspections (e.g., FDA, EMA, MHRA) and provide GMP support to ensure audit and inspection readiness.
• Evaluate and interpret new or changing regulations and standards; assess impact and implement necessary changes to systems and procedures.
• Partner with the quality oversight of external manufacturing organizations to ensure effectiveness of the Quality Regulatory surveillance process on global / local level.

Training and Education

• Assist the designing and implementation of training programs to facilitate system deployment and ensure regulatory compliance.
• Support global quality teams providing GMP knowledge and regulatory interpretations.
• Promote awareness of quality principles and practices across the organization.
• Contribute to the reinforcement and enhancement of the quality mindset across Sobi.

Governance & Stakeholder Management

• Participe in quality system governance meetings and report system performance to leadership.
• Collaborate with Quality Oversight leaders and cross-functional stakeholders (e.g. Operations, Regulatory Affairs, Supply Chain, Validation, IT) to implement and sustain GMP requirements within the quality systems.
• Work closely with global QA and IT teams to maintain and enhance electronic Quality Management Systems (eQMS).

Collaboration and Communication

• Ensure alignment of global / local processes across GMP areas by implementing essential quality mechanisms.
• Develop and disseminate effective communication within the organization concerning quality-related matters. GPO Collaboration
• Assist process owners in developing training strategies for employees affected by their respective processes and may serve as the GPO for specific processes
• Support inspection readiness helping GPOs standardize the preparation and execution of inspections. · Provide guidance and support to identify and address regulatory compliance gaps in GMP areas.
• Update GPOs on changes in the QMS.

Qualifications

Education/Learning Experience/Work Experience

• Minimum 5+ years of GMP experience in pharmaceutical or biotech industry with 5+ years within Quality system, or manufacturing.
• Bachelor's degree in Life Sciences, Pharmacy, Regulatory Affairs, or a related field (preferred).

Skills/Knowledge/Languages

• Strong knowledge of global GMP regulations (e.g. FDA, EMA, ICH, PIC/S).
• Experience in quality systems design, implementation, and compliance, specifically in GMP quality processes.
• Strong project management, problem-solving, and root cause analysis skills.
• Experience in performance management, KPIs, including the Quality Management Review.
• Demonstrated experience in global organisation.
• Proven experience with eQMS platforms.
• Fluent in English

Additional Information

All your information will be kept confidential according to EEO guidelines.