QC - Compliance Manager
That's XPE. For one of our clients we are looking for: QC - Compliance Manager Organisation description:
XPE Pharma & Science offers a unique combination of providing high qualified Scientific, Technical, Commercial and/or Medical expertise through staffing, consultancy, Project management or Project delivery services. We have more than 250 XPErts helping out our clients in different phases of the development process of a drug/medical device or product. As a full service organization XPE Pharma & Science offers those specialized HR & project services to Pharmaceutical, Biotech, Medical devices, Agri-food Industries and the Healthcare & CRO environment.Job description:
Enable corporate R&D objectives through risk management and quality planning across specific Therapeutic Areas (TA) / Disease Area Stronghold (DAS) by partnering with relevant business partners. Under the general direction of the Integrated Quality Plan (IQP) Lead and/or the TA head, the Program Leader is responsible for the development and execution of IQPs to proactively identify and mitigate R&D risks and mitigate significant quality issues that may have an impact on approval or acceptance of health authority submissions, or general compliance to company and industry standards and national and international regulations. Develop and manage integrated quality plans (IQPs) to support business-critical activities (such as health authority submissions to support new molecular entities or new indications for use) Work with risk owners across R&D functions to develop effective risk mitigation plans to control risks identified in the IQP Provide input to trial oversight and audit strategies to ensure that risks are identified in the IQP and mitigated early, and that predefined risk mitigation plans in the IQP are executed in a timely fashion and are effective in mitigating the risk to an acceptable level Manage the utilization of BRQC resources in the IQP. Ensure that BRQC activities are integrated to maximize BRQC support of submission readiness. Lead quality working groups (QWGs) to define and refine the IQP. Organize and lead meetings of the QWG to periodically assess quality metrics and signals to determine if risks are adequately defined and controlled under the IQP. Communicate outcomes of QWG meetings to relevant stakeholders, including senior management. Lead or assist in the early identification, escalation, and resolution of significant quality issues pose a significant risk to achievement of core company objectives. In collaboration with Regulatory Compliance, lead inspection readiness activities to support health authority submissions. Develop and execute pre-inspection readiness strategies for internal R&D and external parties that contribute to regulatory submissions. Leverage quality analytics data and contextualize key quality insights to primary stakeholders and provide quality consultancy. In close consultation with the TA clinical teams (e.g. project management office), maintain oversight of the TA development plans in order to evaluate the importance of specific trials in the context of upcoming submissions, and decide which should be covered with high priority in our IQPs.Profile:
A minimum of a Bachelor's degree is required. An advanced degree (MD, PhD, MSc, or PharmD) is preferred. A minimum of 5 years of experience in a Quality, Compliance, and/or R&D environment is required. Experience in the pharmaceutical industry is preferred. Experience in and/or knowledge of risk management in a regulated industry is required. Industry recognized certifications are preferred. Knowledge of the global drug development process, including current GxP regulations, is required. Understanding of the content and structure regarding Common Technical Documents (CTD) is preferred. Knowledge of FDA/ICH and country-specific regulations and guidelines is required. This position is located in Spring House, PA; Titusville, NJ; Raritan, NJ; Malvern, PA; Beerse, Belgium; High Wycombe, UK; Leiden or Tilburg, Netherlands; (Other locations may be considered). The role may require up to 25% travel.Offer:
What do we offer? Well for this position you will start as a Consultant at XPE Pharma & Science. As a consultant you will get an interesting salary package (contract of unlimited term) and extra legal advantages! If you are still interested, don't hesitate to apply…We have 2 working days to present your application with our client.
XPE Personnel Services NV/SA: Flanders: VG15/BU, Brussels: B-AA5.031, Wallonia: W.RS.002/W.INT.002 XPE Group NV/SA : Flanders: VG1834/B, Brussels: B-AA11.007, Wallonia: W.RS.713