Senior Specialist Global QMS

Orca Bio, a forward-thinking biotechnology company dedicated to transforming the transplant landscape, is seeking a seasoned Senior Specialist for their Global Quality Management System (QMS). This organisation is at the forefront of developing advanced cell therapies, aiming to significantly improve patient survival rates and reduce the inherent risks associated with current transplant procedures. Their innovative approach focuses on replacing compromised blood and immune systems with healthy ones, ultimately restoring patients' lives. As a commercial-stage company, Orca Bio is driven by a profound passion for scientific advancement and a deep sense of compassion for those in need. They operate with a sense of urgency, committed to making their life-changing treatments accessible to all patients.

About the Role

This remote position plays a critical role in maintaining and enhancing Orca Bio's global quality framework. The Senior Specialist will be instrumental in ensuring that the company's operations adhere to the highest standards of quality and regulatory compliance across all its sites and functions. The role requires a proactive individual with a strong understanding of GxP regulations and a proven ability to drive quality initiatives on a global scale. Collaboration will be key, as the successful candidate will work closely with various internal teams, including IT and site leadership, to refine and implement the QMS.

The Senior Specialist will be responsible for a diverse range of critical quality assurance activities. This includes the planning, execution, and reporting of internal audits across all organisational sites. You will be tasked with developing audit agendas, conducting thorough interviews, reviewing existing processes, and generating comprehensive audit reports.

A significant aspect of the role involves supporting the global Quality Management Review (QMR) process. This entails ensuring the timely collection, analysis, and presentation of data to senior leadership, providing essential insights for strategic decision-making.

Furthermore, you will contribute to the robust supplier qualification and management program. This encompasses conducting risk assessments, performing supplier audits, and implementing ongoing monitoring to guarantee adherence to GxP requirements.

The Senior Specialist will also be central to global inspection management, preparing cross-functional teams and individual sites for inspections by regulatory bodies such as the FDA and EMA. You will provide guidance and oversight to QMR administrators at various sites, fostering consistent implementation of the quality system.

Key responsibilities extend to establishing and monitoring global QMS key performance indicators (KPIs), analysing quality metrics, and ensuring that data-driven improvements are made to quality systems and overall performance. A significant component of the role involves partnering with IT and business process owners to identify and implement enhancements to the QMS, including defining requirements, prioritising changes, and ensuring validation and compliance.

You will also review, approve, and provide quality oversight for validation documentation related to global enterprise systems, such as MasterControl, ERP systems, and Trackwise, ensuring alignment with both regulatory mandates and internal standards. Finally, you will collaborate with cross-functional and site leadership to drive continuous improvement initiatives, ensuring the QMS remains agile and responsive to evolving business needs and regulatory expectations.

What They're Looking For

Orca Bio is seeking a candidate with a Bachelor's degree in a scientific or engineering discipline, with an advanced degree being advantageous. A minimum of five years of relevant experience in Quality Assurance or Quality Systems within a GxP-regulated environment is required, including at least two to three years in a leadership capacity.

A strong command of global quality regulations and standards is essential, including familiarity with FDA, EMA, ICH, ISO 9001, 21 CFR Parts 210/211/820, and EU GMP. The ideal candidate will possess proven experience in leading Quality Management Reviews, managing internal audit programmes, overseeing supplier management processes, and providing validation oversight.

Demonstrated success in establishing and trending quality performance metrics and KPIs is a must. Experience with administering electronic QMS systems and collaborating with IT on system enhancements is highly valued. Previous experience working within a multi-site or global quality organisation is strongly preferred.

Exceptional organisational, analytical, and communication skills are vital, along with the ability to influence and collaborate effectively across different functional areas and geographical boundaries.

In South Africa, senior quality assurance roles in the pharmaceutical and biotechnology sectors often command competitive salaries, reflecting the specialised knowledge and experience required. Employers range from multinational pharmaceutical giants with local operations to growing local biotechs and contract research organisations. Career progression typically involves moving into broader quality leadership roles, managing larger teams, or specialising in specific areas like regulatory affairs or compliance.

• Bachelor’s degree in a scientific or engineering discipline required; advanced degree preferred.
• Minimum 5+ years of relevant Quality Assurance or Quality Systems experience in a GxP-regulated environment, with at least 2-3 years in a leadership role.
• Strong knowledge of global quality regulations and standards (FDA, EMA, ICH, ISO 9001, 21 CFR Parts 210/211/820, EU GMP).
• Proven experience leading Quality Management Review, internal audit programs, supplier management processes, and validation oversight.
• Demonstrated success in establishing and trending quality performance metrics and KPIs.
• Experience supporting and/or administering electronic QMS systems and partnering with IT for system enhancements.
• Experience working in a multi-site or global quality organization strongly preferred.
• Excellent organizational, analytical, and communication skills, with the ability to influence and collaborate across functional and site boundaries.