The R&D Quality & compliance lead will be responsible for GARDP’s R&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.
R&D Quality and Compliance Lead will provide strategic leadership to ensure governance and oversight of R&D’s quality assurance processes (including audit strategy and inspection readiness/execution) and identification and evaluation of quality and compliance risks and issues to R&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, R&D project leadership; global access) and with key development and commercial partners.
R&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 R&D and Medical Leadership and across GARDP to support the development of R&D positions and policies related to non GxP quality and R&D compliance including open data access and data protection...
Tasks and Responsibilities:
- Lead R&D Quality & Compliance to implement and continuously improve the R&D Quality Management System and mitigate risks throughout the R&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 R&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 R&D process and procedures.
- Implement an evaluation & reporting framework of quality and compliance risks to executive leadership
- Set a vision for R&D Quality & Compliance driving value through a risk-based, proactive & preventative approach to quality
- Ensure GARDP’s quality requirements for Access including commitment to quality supply are addressed in all collaborations and licensing agreements.
- 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.
R&D Quality and compliance
- With the GARDP Head of Pharmaceutical Development to support the quality oversight of manufacturing technology transfer process and the implementation of any ongoing manufacturing oversight where appropriate.
- Work with GARDP Head of Pharmaceutical development and DNDi Pharmaceutical Development Director to determine GARDP’s QA requirements and implementation within the shared GARDP-DNDi CMC platform
- Identifies potential R&D level QM systemic gaps and coordinates with the appropriate stakeholder to ensure timely remediation. As appropriate, escalate issues of critical non-compliance and/or lack of urgency in remediation to the appropriate stakeholder(s)
- Work with other functions to ensure policies, positions and processes are in place to support R&D compliance with non GXP national and international regulations and frameworks that impact R&D (eg, data protection, access etc)
- Develop and measure quality metrics to drive consistent quality standards throughout the organization.
Additional /specific/projects responsibilities
- Work across R&D, Medical and GARDP including legal to ensure R&D related principles and policies are in place and aligned with quality and compliance standards to support success R&D progress (eg, open data access, data protection etc).
- S/he reports to the R&D Director
- Clinical QA team members
- R&D team members including Medical, Regulatory
- Global access
- External service providers and consultants in the functional area.
Skills and Attributes
- Excellent written communication skills
- Very strong strategic, critical thinking skills demonstrating ability to collaborate and influence to lead change
- Proven experience with overseeing including strategy and implementation of a quality management system
- Excellent management and communication skills in multicultural, multi-lingual environments
- High ability to use initiative, prioritize, multi-task, and work well under pressure to meet deadlines
- Very clear and systematic thinking that demonstrates strong judgment and problem solving competencies
- Provide specialist services to project teams and functions
- High ability to interact with internal and external stakeholders
- High ability to lead and motivate a team for optimum performance
- High ability to exercise high degree of independence to ensure program delivery and explore new areas of activities
- High ability to lead large strategic projects
- Highly organized and structured
- High analytical skills
- High ability to manage large size projects with budget management
- Minimum 10 years in a drug development environment from pharma, biotech or non-for profit sector and at least 8 + years in a quality or compliance related discipline with significant quality management accountabilities.
- Working knowledge of international GXP (GCP, GMP, GLP) regulations and directives, including USA (FDA), EU (EMA), WHO, key priority countries (South Africa, India, Asia, Latin America) and ICH Guidelines.
- Strong understanding of GCP regulations and knowledge of other GXPs including GMP as it relates to product supply
- Global health authority experience from the quality aspects (inspections or related interactions.
- Previous experience in clinical quality audits and regulatory inspection, including development of plans for corrective and preventive actions.
- Graduate or post graduate degree in an appropriate scientific discipline
- QA related/clinical research professional qualification
- Fluency in English
- Proficiency in local languages desirable
- Good knowledge of Microsoft Suite and Clinical quality management systems
- Please submit your application using the online form
- Accepting applications until October 24th 2023 EOB
- All candidate will be reviewed after closing date
- Only shortlisted candidates will be contacted
- UK and Spain employees are home-based