To provide global training service and operational systems support together for all Pharma Development Quality (PDQ) supported business functions (gRED, pRED, PD, GPS and affiliates) for all relevant Clinical & Pharmacovigilance regulatory compliance training.
To ensure appropriate rollout of GxP training plans in the global learning management systems, training communications and training operations.
To contribute to the reporting and analysis of training compliance metrics within PDQ and the supported business functions, including affiliates, and follow-up where required
Primary Responsibilities and Accountabilities: Contributes to the execution of the training operations plan and strategy Supports the test, upload, deployment of training programs required as part of the Quality Management System Acts as the Training System Specialist responsible for the end to end process and works closely with the Standard Operating Procedures (SOP) and Learning Solutions group in PDQS to ensure timely planning and execution of the training roll-out plan for procedural documents. Oversees the administration of global and local training programs within the Learning Management Systems, maintains and updates role-based training curricula, and delivers training compliance reports in accordance with defined processes. Leads Training System projects by incorporating concepts of Project Management Methodology (PMM) Collaborates with key business stakeholders to help ensure that global, functional and local training grids are accurate and current Performs quality checks on all training assignments, training deployments, metrics reporting and communication provided on behalf of PDQS Training Systems & Operations function. Communicates the training requirements to business stakeholders including completion timelines, curricula requirements for existing employees and new hires, in addition to providing status updates on all inquiries through the use of all available communication channels. Proficient technical and business expertise for all IT tools required to support the administration of the PDQ Training Quality System in a compliant and efficient manner and integrated training evaluation methodologies that measures training effectiveness. Provides Tier 1 customer service support and ensures issues (e.g., user requests, change control) are resolved in a timely manner. Generates innovative ideas and/or investigate potential methods in streamline workflow processes Ensures that business partner expectations for training operations and deployment are met. Contributes to the PDQS Training Systems & Operations & PDQS Learning Solutions Teams to set strategies and achieve the long-term goals & objectives for PDQS and PDQ as a whole. Well versed in all services and activities provided by PDQS Training Systems & Operations, PDQS Learning Solutions, and PDQ in order to provide business stakeholders with a comprehensive overview and effectively communicates how their training needs can be met. Provides training and knowledge sharing sessions to peers and to functional and affiliate Training experts
Education/Qualifications: Bachelor degree in Science-related subject or other related field or equivalent work experience. Experience in the pharmaceutical industry, preferably development and working in a GxP regulated area; broad understanding of global expectations of Health Authorities in the area of Pharma Development. Experience in preparation and administration of GxP training programs. Training and Curricula development experience including oversight and administration of validated electronic training management systems Considerable organizational awareness (e.g. interrelationship of departments, business priorities), including significant experience working cross-functionally and in global teams. Affiliate experience preferred.
Minimum : Demonstrated knowledge of GCP, Pharmacovigilance/drug safety and regulatory requirements, as well as analytical, organizational and planning skills. Desired: Substantial knowledge of all services and activities provided by PDQ, Change Management expertise.
Experience, Skills, Knowledge: Solid knowledge of GCP, PV and regulatory requirements. Customer focused approach, and highly effective teamwork and collaboration skills. Ability to build and maintain relationships with key business partners. Ability to analyse and simplify complex systems or processes into pragmatic solutions. Ability for problem identification/resolution in a complex environment or potential conflict
Can effectively communicate, influence and lead both with and without authority. Proficient in project and change management methodologies Ability to work effectively in an international multicultural matrix organization. Fluency in written and spoken English.
Please note this role closes on Friday 30 August 2019.
· Who we are
Our UK Pharmaceutical head office is situated in Welwyn garden City, Hertfordshire, with beautiful country side surrounding the area. Supported by major motorways & airports as well as being a 30 minute train ride to London, access is easy. With over 1400 people occupying our site in Welwyn, you can expect opportunities in Early Development (pRED), Product Development (PD), Commercial (Rx) and of course our corporate function.
Roche is an equal opportunity employer and strictly prohibits unlawful discrimination based upon an individual's race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.Apply for this job