Ph3Associate Director Quality – Client Dedicated Process QD Manager (m/w/d) /h3 h3Key Accountabilities /h3 pThe Associate Director Quality – Client Dedicated Process QD Manager performs various activities in support of process elaboration, design/mapping, documentation (controlled documents and managed information documents) development, review, formatting, and revision for GDO. Support focuses on ensuring that good process design principles and appropriate documentation standards are consistently applied, that activities are consistently and efficiently coordinated and that deliverables are completed in a high quality and timely manner. Support may also be provided to coordinate audits and audit response processes and to ensure compliance with agreed CAPA due dates, as needed. In addition, the Process QD Manager is in charge of coordinating GDO training assignments, Managed Information and cross-functional QD reviews (incl. representation of GDO in DEC). /p h3Key Role Responsibilities /h3 h3Process Management (BPC role) /h3 ul liSupports/guides BPOs in the process to develop or update process design (end-to-end process design including set-up expectations, perform Elaboration Workshop and coordinate Cross-functional Alignments, Document Authoring responsibilities). /li liEnsures adherence to RD documentation standards, process orientation, simplification, visualization, harmonized core language, regulatory compliance and harmonization of processes and QDs within GDO. /li liDevelops/revises process flow diagrams using the designated system and notation standards and supports the GDO organization as an expert for efficient process design and illustration. /li /ul h3Controlled Document Managed Information Document Management /h3 ul liResponsible for the development, review/revision, maintenance and continuous improvement of Quality Documents (incl. CDs and MIs) for GDO. /li liEnsures timely review/revision of existing processes QDs within GDO, maintaining compliance with review/renewal timelines. /li liOwns GDO Managed Information Document Management Cabinet. /li liCoordinates review and revision of documents with all appropriate stakeholders in cooperation with the process/document owner. /li liEnsures compliance with document content and formatting standards. /li liEnsures timely and adequate communication on behalf of the DEC to the GDO organization. /li /ul h3Training Management and Oversight /h3 ul liMaintains training matrix, coordinates training roles, and works with Training Representatives to optimize assignments in GDO. /li /ul h3Audits and Inspections /h3 ul liSupports the preparation, coordination, and response for audits and inspections, as appropriate to area of responsibility. /li /ul h3Qualifications and Requirements /h3 ul liAdvanced degree in Life Sciences (e.g., biology, chemistry, pharmaceuticals) or equivalent. /li liMinimum 12 years of experience in clinical development in pharmaceutical industry or CRO or equivalent including at least 5 years direct involvement in sponsor–CRO interaction for global trials. /li liExperience in different functions in the clinical development area. /li liExperience as line manager and/or as leader of cross-functional virtual international teams. /li liRequires deep knowledge of one or more related job areas typically obtained through advanced education combined with experience. /li liSound working knowledge of relevant terminology, ICH, GCP, SOPs, applicable regulatory requirements, quality management processes. /li liExcellent organizational, interpersonal and communication skills. /li liExcellent judgement and decision-making skills. /li liDemonstrated leadership and line management skills. /li liExcellent influencing and negotiation skills. /li liStrong computer skills including Microsoft Office applications. /li liExcellent problem-solving skills. /li liDemonstrated ability to work in a matrix environment. /li liAbility to lead and motivate a clinical team also required. /li liAbility to travel within the region/country. /li liAbility to establish and maintain effective working relationships with co-workers, managers and clients. /li liFluent in English. /li /ul h3Preferred /h3 ul liDocument management experience. /li liiGrafx/process design experience. /li liGCP audit/inspection support experience. /li /ul pLocation: TN Switzerland – Canton of Lucerne, Switzerland /p /p #J-18808-Ljbffr