Clinical FSP Quality Manager

Munich, Bavaria, Germany

Mexico City, Mexico

Chennai, India

Basel, Switzerland

Warsaw, Poland

Kirkland, Quebec, Canada

Durham, North Carolina, United States of America

Barcelona, Spain

Sofia, Bulgaria

Madrid, Spain

Tokyo, Japan

Bratislava, Slovakia

Buenos Aires, Argentina

Athens, Greece

Beijing, China

Reading, Berkshire, United Kingdom

Mumbai, India

São Paulo, Brazil

Full time

Job Overview

This role is an individual contributor assigned to designated Delivery Unit(s), sponsor(s), business line(s), and/or specific tasks as defined by the line manager (LM). The purpose of this role is to work together with global or regional Quality Management team(s), functional teams, and other stakeholders in a joint effort to clearly define the global Quality Plan, carry out, and adopt the plan according to the specific needs defined by the scope of assignment, assist staff in improving compliance with relevant International Conference on Harmonization (ICH), Good Clinical Practice (GCP), Standard Operating Procedures (SOPs), Key Performance Indicators (KPIs), applicable regulatory requirements, and guidelines.

Essential Functions

Adopt and implement the global 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.;

Cooperate closely with the relevant business and other stakeholders, support maintaining focus on quality in project delivery.

Contribute to the development and implementation of a Delivery Unit/Sponsor specific Quality Management plan and Risk Management Program, monitor the implementation and delivery.

Provide advice and support to teams within the assigned business line and other key stakeholders on all aspects of Good Clinical Practice (GCP) compliance.

Work in close cooperation with teams to manage non-compliance, quality issues, support in planning corrective/preventive actions, as applicable according to Standard Operating Procedures (SOPs.);

Inform Quality Management, the assigned business line, and Quality Assurance of quality issues according to SOPs.;

Inform Quality Management, the assigned business line, and Quality Assurance of quality issues according to SOPs.

Work 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 business lines, as required by the applicable SOPs.

Act as the primary contact for Quality Assurance on quality matters – on the level of the assignment, attend meetings/teleconferences.

Prepare periodic reports to business lines on quality related matters, risk assessments and specific quality improvement initiatives.

Upon agreement with the line manager:
Perform any other reasonable tasks as required by the role.;

Qualifications

Expert knowledge of and experience in (
minimum of 8 years ) processes related to clinical trial design, planning, start up, conduct, analysis, and reporting clinical development (principles and concepts as well as regulatory environment).

Knowledge of National and International Regulations and Drug Development processes.

Knowledge of Clinical Research Organization (CRO) or Pharmaceutical industry operations.

Excellent problem solving skills.

Ability to establish and maintain effective working relationships with co-workers, managers and clients/customers.

Fluent in English.

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