Munich, Bavaria, Germany

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Job Overview

This role is assigned to designated Delivery Unit(s), country/countries, sponsor(s), business unit(s), and/or specific tasks as defined by the line manager (LM). Contributes to the development and is responsible for the implementation of specific quality improvement initiatives as agreed with the relevant Head(s) of assigned business lines. Provides advice and supports relevant key stakeholders with regards to quality control, risk assessment, risk management, and corrective/preventive actions.

Essential Functions

• The CQM Lead leverages expertise in risk-based quality and study management to drive actions that strengthen & standardize risk-based approach & deliverables via fit-for-purpose business processes/tools.
• Contributes to the development, and supports implementation of the Quality Management Plan within the scope of the assignment this will include: Planning and executing the Quality Management activities. Risk identification and assessment through data review and quality control processes. Providing support in risk mitigation, in planning corrective/preventive actions, and guidance for improvement.



Supporting the assigned business line management and staff to enhance effectiveness in project delivery.;
• Cooperate closely with the relevant business lines and other stakeholders, support maintaining focus on quality in project delivery.
• Provides advice and support to teams within the assigned business line on all aspects of Good Clinical Practice (GCP) compliance.
• Works in close cooperation with teams to manage non‑compliance, quality issues.
• Assist in planning corrective/preventive actions, as applicable according to Standard Operating Procedures (SOPs).
• Informs the assigned business line and Quality Assurance of quality issues according to SOPs.
• Works closely with Quality Assurance and assigned business staff in case of suspected misconduct, as required by the applicable SOPs.
• May provide assistance during audits and regulatory inspections to the teams to the extent agreed with the line manager, as required by the applicable SOPs.
• Acts as the primary contact for Quality Assurance on quality matters - on the level of the assignment, attend meetings/teleconferences.
• Prepares periodic reports to business lines on quality related matters, risk assessments and specific quality improvement initiatives.
• Manages staff in accordance with organization’s policies and applicable regulations. Responsibilities include planning, assigning, and directing work,



appraising performance and guiding professional development, rewarding and disciplining employees, addressing employee relations issues and resolving problems. Approve actions on human resources matters.;
• Upon agreement with the Head of relevant business line: Performs any other reasonable tasks as required by the role.

Qualifications

• Bachelor's or Master's degree in Medical or Life Science (or equivalent industry experience) required, and PhD preferred.
• Expert knowledge of and experience in (minimum of 12 years) processes related to clinical trial design, planning, start up, conduct, analysis, and reporting clinical development (principles and concepts as well as regulatory environment).
• Sound working knowledge of relevant terminology, International Conference on Harmonization (ICH), Good Clinical Practice (GCP), Standard Operating Procedures (SOPs), applicable regulatory requirements, quality management processes.
• Excellent organizational, interpersonal and communication skills.
• Excellent judgement and decision-making skills.
• Demonstrated leadership and line management skills.
• Excellent influencing and negotiation skills.
• Strong computer skills including Microsoft Office applications.
• Excellent problem-solving skills.
• Demonstrated ability to work in a matrix environment.
• Ability to lead and motivate a clinical team also required.
• Ability to travel within the region/country.
• Ability to establish and maintain effective working relationships with co-workers, managers and clients. xghoner
• Fluent in English.

EEO

Minorities/Females/Protected Veterans/Disabled

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