IQVIA is at the forefront of healthcare innovation and delivery. With the current COVID-19 crisis we are working tirelessly to support our clients and customers to develop vaccines and therapies. The Quality Manager, Lifecycle Safety, is responsible for quality, compliance and deviation management across global Lifecycle Safety functions including ICSR case processing, Regulatory reporting, Medical Information, endpoint adjudication and aggregate reporting. This leader will partner with Lifecycle Safety functional specialists and/or management to assess quality trends, processes and procedures for continued improvement opportunities including CAPA management.
This pivotal quality expert will support Lifecycle Safety Functions with preparation, including training for audits and inspection, hosting of those audits and inspections and will support CAPA owners to resolution. Utilising your experience and expertise you may also support our Lifecycle Safety clients with Quality Management activities on their accounts.
- 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 either remote or on site; providing support in risk mitigation, in planning corrective/preventive actions and guidance for improvement;
- Review Non compliance & Deviation reports for accuracy, RCA and CAPA plans.
- Cooperate closely with the relevant Heads of business and other stakeholders, support maintaining focus on quality in project delivery. Contribute to the development and implementation of a Regional/Delivery Unit/Sponsor specific Quality Management Plan and Risk Management Program, monitor the implementation and deliver.
- Provide advice and support to functional operational teams within the Lifecycle Safety Department including ICSR case processing, Regulatory reporting, Medical Information, endpoint adjudication and aggregate reporting
- Work in close cooperation with operational teams to manage non-compliance, quality issues; assist in planning corrective/preventive actions, as applicable according to SOPs.
- Inform Heads of Quality Management, Heads of 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.
- Provide assistance during audits and regulatory inspections to the operational teams to the extent agreed with the Head of QM and as required by the applicable SOPs.
- Act as the primary contact for Quality Assurance on clinical quality matters - on the level of the assignment -, attend meetings/teleconferences.
- Prepare periodic reports to Heads of Quality Management and to stakeholders on quality related matters, risk assessments and specific quality improvement initiatives.
- Upon agreement with the Head of Quality/Operational Management: May serve as Line Manager of Quality Specialist (QS), Sr QS and/or QM; May serve as Lead QM for a project or program; Perform any other reasonable tasks as required by the role.
- If job holder is delegated as Line Manager: Manage 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.
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
- Sound working knowledge of medical terminology, clinical monitoring procedures (SOPs), ICH-GCP, applicable regulatory requirements, quality management processes
- Knowledge of National and International Regulations and Drug Development processes
- Knowledge of CRO or Pharmaceutical industry operations
- Knowledge of Quintiles 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 and Clinical Trial Management System (CTMS) applications
- Demonstrated ability to work in a matrix environment
- Excellent problem-solving skills
- Ability to travel within the region/country
- Ability to lead and motivate a clinical team
- Ability to establish and maintain effective working relationships with co-workers, managers and clients/customers
MINIMUM REQUIRED EDUCATION AND EXPERIENCE
- Bachelor's degree in life sciences or equivalent nursing qualification with a minimum of 6 years' experience in Lifecycle Safety (Pharmacovigilance, CEVA, Medical Information, Safety Publishing, Risk Management, etc). Preferably with 2 of these years being in a related Quality position.
- Fluency in English language skills.
At IQVIA, we believe in pushing the boundaries of human science and data science to make the biggest impact possible - to help our customers create a healthier world. The advanced analytics, technology solutions and contract research services we provide to the life sciences industry are made possible by our 67,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way. Learn more at jobs.iqvia.com.