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Director R&D Quality
vor 3 Monaten
Date: 17 Jul 2024
Passion for Innovation. Compassion for Patients.
We are seeking highly qualified candidates to fill the position:
Director R&D Quality (m/f/x)The Position:Lead the implementation of the quality strategy closely aligned with the business strategy within one or more Global Project Team(s) (GPT) within Oncology Development Franchises or Business Units.
Provide strategic and proactive QA Leadership for respective GPTs, R&D Clinical Programs and Post marketing studies or Post approval commitments in close alignment with the Head of R&D QA. Within assigned GPTs, facilitate the implementation of a risk-based quality management process fully embedded through trial design, execution and submission including all vendor managed business setups with the objective of achieving the highest data quality standards, full adherence to patient's rights and well-being and in support of successful Health Authority inspections and approvals.
Lead in a proactive and strategic way and through collaboration with other GxP Quality representatives, act as QA point person for all GxP matters for the Global Program Head and the Global Program Team.
Provide operational QA leadership for the respective GPTs, including Quality Oversight for the Quality Plan execution, Health Authority Commitments, Critical Incidents including, respective escalation and the CAPA Management Process for the respective business areas.
Facilitate the implementation of the quality strategy in close alignment with the GPT business strategy. Monitor and track implementation and break-down of the Quality Manual into an annual Quality Plan together with the supported GPTs including the quality risk assessments and inspection readiness components for the designated programs. Ensure proactive representation of Quality professionals at strategic project team and at GCP strategic discussions.
Support the Head of R&D QA with Quality Reviews of respective product profile to ensure appropriate management review of all quality and compliance related topics including the review of Key Quality Indicators (KQIs). Identify appropriate continuous improvement initiatives for quality and compliance related areas. Deputize for the Head of R&D QA at the Development Leadership teams, as appropriate and as needed.
Interact with senior Oncology Business Unit and Functional Units leadership teams to ensure Quality is consistently and proactively represented at program level and along the clinical trial process in support of a proactive quality risk management process. Interact with the audit function, the respective Data Management groups and respective CROs in order to ensure high data quality and proactive detection and resolution of issues.
Lead effective communications within the GPT, by interacting with other GxP QA functions (GMP/ IMP QA, Audit and Compliance, Quality Management System (QMS) QA and PV / MA Quality) and in close collaboration with CAPA Manager), on GxP topics/Issues impacting the respective clinical programs.
Help to Ensure, in collaboration with CDO (Clinical Development Operations) or other business process owners, that applicable clinical development processes and quality standards which are in line with worldwide HA requirements are implemented. Help to establish in-built controls in relevant process steps to ensure adherence to regulatory compliance.
Monitor effectiveness of implementation of applicable clinical development processes through KQIs in collaboration with business process owners to demonstrate that processes are in control and ensure required compliance levels. Implement and lead the process to regularly review and assess KQIs at the respective GPTs and prepare respective management documentation for the QA Head for review at the Quality Leadership level and Development Leadership level/ governance teams. Ensure that potential gaps and risks are addressed and opportunities for continuous improvement identified.
Quality Oversight: Ensure adequate and timely escalation of incidents/issues within GPTs and QA. In collaboration with GxP CAPA Leads, provide Quality oversight for deviations/incidents investigations, and ensure that adequate CAPAs are defined, implemented and their closure tracked. Ensure that proper Quality oversight is implemented within the GPTs for 3rd parties/vendors/outsourced activities. Provide oversight over the implementation of CAPA effectiveness checks. Share quality status information to business functions is a timely manner at appropriate forums (e.g., OPL forums, regional forums, other RD governances), including the support of creating and reviewing quality metrics for the Quarterly Quality Report (QQR) and Clinical Quality Review Boards (cQRBs).
Ensure continued submission and inspection readiness for the respective GPTs and related submissions. Facilitate respective regulatory inspection preparation, management and follow-up in collaboration with business functions. Support local inspections with adequate systems and process support.
Support through open and effective communication and business partnering the cross-functional implementation of the Strategy, and Vision and Mission of Global RD/PV QA. Drive a culture of solution oriented and evidence-based mind-set with openness for innovative ways of working and new technologies.
Lead Lessons learned information flow at the GPT/ Clinical Operations level based on audit and inspections findings, regulatory intelligence, effectiveness checks and process improvement. Ensure CAPAs are coordinated and communicated to drive shared learnings and standardized response.
Ensure Business Stakeholders are educated on common deviations/QI’s to reduce volume, based on proper planning and execution and to build a stronger quality organization.
Qualifications:Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation. Education Qualifications
- Bachelor's Degree in Life Sciences, Pharmacy or Medicines required
- PhD or advanced degree in Life Sciences, Pharmacy or Medicines preferred
Experience Qualifications:
10 or More Years of involvement in regulated activities, clinical development, and QA (preferably) leadership positions; broad understanding of global expectations of Health Authorities in the area of Clinical Development; profound understanding of the science of product development preferred.
Demonstrated experience and broad understanding of post marketing studies and post approval safety studies (PASS).
10 or More Years of demonstrated accomplishments in a global/matrix environment in the pharmaceutical industry.
Must have expertise in leading/managing (Global) projects.
Must possess strong leadership, interpersonal, communication, negotiation and problem-solving skills.
Must have ability to work independently and in a team environment.
Demonstrated experience and proven track record of successfully leading projects with high impact.
Ability to effectively interact with and present to senior management at all levels, as well as to external audiences and inspectors. Preferred
Considerable organization awareness (e.g., interrelationship of departments, business priorities), including significant experience working cross- functionally and in global teams.
Strong Industry Network in clinical development. Knowledge and understanding of cultural differences and diversity issues.
Strong written and oral communication skills (English).
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