Senior Manager Quality & Compliance Clinical Development

The Position

Tasks & responsibilities

• In your new role, you will act as key contact for Global Quality Medicine (Business Partners and Compliance Managers) and serve as a member of relevant working groups.

Global Quality Processes

• Furthermore, you will define quality and compliance goals, drive implementation and ensure oversight of  quality related processes (focus GCP) and projects within TMCP under consideration of Quality Medicine (QM) Strategy as well as departmental needs.

• You will support TMCP in ensuring GCP compliance and inspection readiness, including in clinical trials with patients and healthy volunteers, while providing proactive GCP guidance and advice to project, study and functional teams.
• Additionally, you will ensure awareness and adherence to international GxP and Pharmacovigilance, regulatory requirements, In Vitro Diagnostic Regulation (IVDR), Medical Device Regulation (MDR) and industry best practices.

• The support and supervision for Quality and Compliance topics within TMCP as well as the monitoring of in-process quality control checks and the identification of Corrective Actions and Preventive Actions (CAPAs) will be part of your responsibilities.
• You will also support and collaborate with Global Process Owners (GPOs) and functional quality employees to identify and implement process improvements.

• You will work with TMCP functions, Global Sourcing, Legal, and Quality representatives to manage supplier qualifications and ensure overall quality and compliance assurance, while developing innovative supplier qualification strategies.

• Moreover, you will develop and support inspection readiness activities and act as business point of contact for auditing and inspection readiness as well as conduct; also, you will provide direct inspections and audits support (training, preparation and management).
• You will ensure follow-ups on quality-related findings from audits and inspections.

• In addition, you assume process ownership, define strategies and oversight for NCs
• You will also support in initial assessment of potential NCs, root cause analysis, creation of CAPA plans, identification of CAPA Leads / act as CAPA Lead  and database entries, all in collaboration with QM.

Requirements

• Master's degree in a scientific field, such as Biology, Biochemistry, or Chemistry with longstanding extensive professional experience in Good Clinical Practice (GCP) related environment, PhD desirable
• Extensive experience with GxP quality management processes and systems.
• In-depth knowledge of local and global GCP regulations with robust experience in interpreting GCP guidelines for the pharmaceutical industry
• Significant experience in inspection and audit readiness, preparation and management and in (GCP) non-compliances and CAPA management
• Knowledge and experience in drug development, clinical development and GCP for labs
• Applied knowledge of IVDR and MDR as well as experience in companion diagnostics (CDx) development is a plus
• Creative and critical thinker with the ability to identify areas for improvement and independently develop tailored solutions, coupled with strong leadership and assertiveness

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