Description
One of our clients, an international company in the pharmaceutical industry currently requires a Clinical Quality Project Manager
Start:
Length: min. 12 months
Location: South of Brussels
R&D Quality and Risk
Human Subject Research
FUNCTION DESCRIPTION:
The Clinical Quality PM is a business partner who promotes the development of a quality culture, supports implementation and embedding of quality frameworks and standards consistently across the respective R&D vaccines areas. She/he integrates, prioritizes and escalates risk and compliance issues .The PM as per his/her level of expertise, seniority and polyvalence will drive and deliver independently.
This mission requires a thorough knowledge and understanding ofPre-Clinical/Clinical Development processes and the evolving relatedregulations (ICH-GCP, etc.), as well as an understanding of internal and external audit findings and regulatory/government requirements toensure all R&D Vaccines staff, the contractors and suppliersinvolved in the processes, are discharging their duties and ensuringthe highest quality and compliance with regulations.
Must-Have experience for the mission are:
QA and ICH-GCP
Good Project Management/Prioritization skills
Work effectively under time pressure & stressful situation.
Good interpersonal skills, especially facilitation, negotiation, and influencing skills
KEY RESPONSIBILITIES:
*Ensures local training created to meet departmental needs is aligned with R&D vaccines' training strategy.
*Ensures regular review and update of training curricula for the relevant R&D area
*As risk facilitator supports the Vaccines risk management framework implementation, including risk identification, assessment and prioritisation and the definition of mitigation plans
*Coordinates and interprets transversal risks in the area of support
.Coaches business on principles and implementation activities, develop transversal tools and implementation plans. Keep a global overview on all activities and interfaces at area level.
* Aligns with assessment groups on a regular basis to ensure alignment on all quality aspects. Supports audit and inspection awareness coordinates preparation and supporting activities and ensures CAPA implementation and effectiveness.
* Resolve consultancy questions using a risk based approach
* Supports the management of for-cause and serious breach situations..Identifies the appropriate SME for consultation of new/draft legislation, support the SME with impact assessment on existing operations and follows up on implementation.
* Monitor, interpret & ensure visibility of the quality &compliance performance through assessment of compliance, quality trends & metrics. Attends the Transversal Quality Forum and work in collaboration with the QRM Center of Expertise
* Support the roll-out of Compliance/Values initiatives, by tailoring initiatives to the areas and informing the business accordingly.
* Ensure learning from CAPA and RA intelligence is integrated in process and associated control and training at all levels
*Promotes knowledge and information sharing with other QRM area managers and LOCs
PREREQUISITES:
Education:
Master, or equivalent relevant professional experience
Health Care, Pharmacy, Biomedical Sciences, Quality Assurance &Risk Managements in Human Subject Research (ICH-GCP, QA, Inspection& Audit)
Knowledge - Job related experience:
* Knowledge of essential regulatory and industry guidelines world-wide, eg detailed knowledge of ICH and FDA/EMA regulations as these impact all aspects of vaccine development.
* A broad scientific/pharmaceutical industry background inpharmaceutical research with at least 8 years' experience.
* Previous experience in quality assurance and risk management areas,including root cause analysis, Audit & Inspections
* Detailed knowledge of the drug/vaccines development and pre- andclinical processes.
* Thorough knowledge and understanding of Pre-Clinical/ClinicalDevelopment processes and the evolving related regulations (GCP, GLP,etc.), as well as an understanding of internal and external auditfindings and regulatory/government requirements to ensureall staff, our contractors and suppliers involved in the processes, aredischarging their duties and ensuring the highest quality andcompliance with regulations.
* Able to understand and interpret regulations and implicationsfor vaccines pre-clinical and clinical development processes
Other skills and background:
* Able to set and manage priorities
* Good resistance to stress, able to work efficiently under pressure.
* Good interpersonal skills, especially facilitation, negotiation, andinfluencing skills
.Able to lead and work within teams and networks across functional andgeographical boundaries; leads by example and promotes collaboration,effective communication and leadership in others
* Analytical skills, including the ability to gather, summarize andinterpret complex information from multiple internal and externalsources
* Excellent English skills
* Project Management Skills
* Demonstrates conceptual, analytical thinking
* Enterprise thinking mindset and transversal approach required,considering the complexity of the role in managing multi-functionalteams and representation of QRM across the organization.
* Given the complexity of R&D, requiring good analytical andcomplex problem solving skills, able to assess and manage risk. Ability to adapt to a changing and challenging environment
Tags:
GCP, pharmaceutical, QA, Project Management, training, R&D,CAPA, risk, inspection