RD Quality and Compliance Lead (Switzerland - or remote from the UK/Spain)
Global Antibiotic RD Partnership (GARDP), Switzerland

The Ramp;D Quality amp; compliance lead will be responsible for GARDP’s Ramp;D quality management systems development and implementation including quality risk management, processes and supporting an approach to quality that supports GARDP’s objectives. This includes quality and compliance elements covering clinical QA activities as a priority via Good Clinical Practice (GCP) but also will include support for quality oversight of pharmaceutical development activities (and GMP where appropriate) with our partners and support for non-clinical activities via Good Laboratory Practice (GLP) and general good research practices where appropriate ensuring compliance with relevant national and international regulations.

Ramp;D Quality and Compliance Lead will provide strategic leadership to ensure governance and oversight of Ramp;D’s quality assurance processes (including audit strategy and inspection readiness/execution) and identification and evaluation of quality and compliance risks and issues to Ramp;D and executive leadership

S/he is responsible for setting a culture of a proactive, risk-based and preventative approach to quality that adds value to GARDP’s objectives. This will require strategic direction and tactical implementation in cross function environment (Clinical operations, Medical/safety, Ramp;D project leadership; global access) and with key development and commercial partners.

Ramp;D Quality and Compliance Lead will initially focus on further development and implementation of the clinical quality management system(s) as a priority leading the team to support quality commitments for regulatory submissions including project and institutional inspection readiness.

In addition, s/he will work with Ramp;D and Medical Leadership and across GARDP to support the development of Ramp;D positions and policies related to non GxP quality and Ramp;D compliance including open data access and data protection...

Tasks and Responsibilities:

Overall:

• Lead Ramp;D Quality amp; Compliance to implement and continuously improve the Ramp;D Quality Management System and mitigate risks throughout the Ramp;D projects lifecycle to ensure patient safety and data integrity.
• Work with all relevant stakeholders across GARDP and its partners or vendors to ensure that activities performed in Ramp;D with a primary focus on clinical but including support for pharmaceutical development, are conducted in compliance with all GxP, local/regional, corporate, donors, and relevant international regulations.
• Maintain relevant knowledge of GCP and and other appropriate GxP /regulatory/standardsrequirements and implement these in Ramp;D process and procedures.
• Implement an evaluation amp; reporting framework of quality and compliance risks to executive leadership
• Set a vision for Ramp;D Quality amp; Compliance driving value through a risk-based, proactive amp; preventative approach to quality
• Ensure GARDP’s quality requirements for Access including commitment to quality supply are addressed in all collaborations and licensing agreements.

Clinical QA

• Provides expert input in Clinical QA plans and ICH-GCP compliant processes to meet GCP quality standards in order to control the quality of clinical trials conducted and sponsored by GARDP.
• Collaborates with project teams providing QA support in oversight of CRO vendors, and clinical investigator sites while assessing compliance with local regulations, GCP/ICH requirements, clinical study protocols and SOPs
• Lead or assist with identifying non-compliances with requirements, provide suitable recommendations and facilitate ongoing quality improvements using risk-based methodology while maintaining compliance with applicable study protocols and Quality System Regulations where applicable.
• Lead qualification, routine and for-cause audits of CRO, investigator sites, laboratory and other vendors and collaborate with auditors and auditees to ensure appropriate implementation of Corrective and Preventive Action Plans (CAPAs)

• Responsible for the leadership of the Inspection and Audit Readiness program, identifying and addressing compliance issues to strengthen Quality and ensure a state of readiness for regulatory inspections.
• Advise on the need for, internal audits (TMF, systems, processes, vendors, computer system validation).
• Oversees the maintenance of the Clinical QMS (including SOPs) , working with other(s) in QA department and clinical team for updates, improvements and new document creation.
• Oversight of audit observations and CAPAs documentation and implementation.

Ramp;D Quality and compliance

• With the GARDP Head of Pharmaceutical Development to support the quality oversight of manufacturing technology transfer process and the imp

Job Rewards and Benefits