Clinical FSP Quality Manager at IQVIA

Bucharest, Bucharest, Romania

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Not SpecifiedCompensation

Mid-level (3 to 4 years), Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Clinical Research, PharmaceuticalIndustries

Requirements

Bachelor's Degree or equivalent qualification
Equivalent combination of education, training, and experience
Sound working knowledge of medical terminology, Standard Operating Procedures (SOPs), International Conference on Harmonization (ICH), Good Clinical Practice (GCP), applicable regulatory requirements, quality management processes
Knowledge of National and International Regulations and Drug Development processes
Knowledge of Clinical Research Organization (CRO) or Pharmaceutical industry operations
Knowledge of IQVIA corporate standards and SOPs
Good organizational, interpersonal and communication skills
Good judgement and decision-making skills
Strong influencing and negotiation skills
Strong computer skills including Microsoft Office applications
Excellent problem solving skills
Ability to occasionally travel within the region/country
Ability to lead and motivate a clinical team
Ability to establish and maintain effective working relationships

Responsibilities

Adopt and implement the global Quality Management Plan within the scope of the assignment, including planning and executing Quality Management activities, risk identification and assessment through data review and quality control processes, providing support in risk mitigation, planning corrective/preventive actions, and guidance for improvement, and supporting assigned business line management and staff to enhance effectiveness
Cooperate closely with relevant business and other stakeholders to maintain 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, and 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 and quality issues, and support in planning corrective/preventive actions as applicable 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 applicable SOPs
Provide assistance during audits and regulatory inspections to teams to the extent agreed with business lines, as required by applicable SOPs
Act as the primary contact for Quality Assurance on quality matters at the level of the assignment, and 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

Skills

Key technologies and capabilities for this role

GCPICHQuality ManagementRisk ManagementCAPASOPKPIRegulatory ComplianceQuality ControlClinical Trials

Questions & Answers

Common questions about this position

What is the employment type for this role?

This is a full-time position.

Is this a remote position or does it require office work?

This information is not specified in the job description.

What qualifications are required for the Clinical FSP Quality Manager role?

A Bachelor's Degree is required.

What are the main responsibilities in this role?

The role involves adopting and implementing the global Quality Management Plan, risk identification and assessment, providing support in risk mitigation and corrective actions, cooperating with stakeholders on quality focus, and advising on GCP compliance.

What experience or skills make a strong candidate for this position?

Strong candidates should have expertise in quality management, risk assessment, GCP compliance, SOPs, and the ability to collaborate with global teams, Quality Assurance, and stakeholders on corrective actions and audits.

IQVIA

Advanced analytics and clinical research services

About IQVIA

IQVIA provides advanced analytics, technology solutions, and clinical research services specifically for the life sciences industry. Their services utilize extensive data resources and technology to create connections within healthcare, allowing clients to gain insights that help speed up the development and marketing of new medical treatments. This process is facilitated by their IQVIA Connected Intelligence™ system, which offers quick and flexible insights. IQVIA stands out from competitors by focusing on patient privacy, employing various technologies to protect individual data. The company's goal is to enhance healthcare outcomes by supporting biotech, pharmaceutical, and medical device companies, as well as researchers and government agencies, in understanding diseases and advancing medical science.

Durham, North CarolinaHeadquarters

1998Year Founded

$3,526MTotal Funding

POST_IPO_EQUITYCompany Stage

Cybersecurity, Biotechnology, HealthcareIndustries

10,001+Employees

Risks

Rapid advancement of cancer vaccines may disrupt traditional clinical research models.

Proliferation of disparate technological solutions causes technology overload in clinical trials.

Generative AI technologies face challenges in adoption due to data privacy concerns.

Differentiation

IQVIA leverages advanced analytics and big data for life sciences solutions.

The company offers privacy-enhancing technologies to protect individual patient data.

IQVIA's AI Assistant provides rapid, actionable insights for healthcare and life sciences.

Upsides

Increased adoption of decentralized clinical trials enhances patient-centric study designs.

AI-driven drug discovery accelerates identification of potential drug candidates.

Expansion of telemedicine facilitates remote patient monitoring and data collection.

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