The Validation Project Manager (VPM) is responsible for the planning and coordination of all Customer projects management and customer-facing activities in China Millipore Validation Services, reporting to the VPM Manager.
The VPM is accountable for:
61 Understanding regulatory and guidelines including but not limited to PDA TR 26, USP 665, BPOG, GMP, Local guidelines. Collecting regulatory finding and replying to customer with supporting of GS experts
61 Providing standard technical support to customer and sales. Helping customers define their needs, answering questions and identify process risk by follow requirements:
84 According to Reg guideline requirements, provide validation tests recommendation for customer process to meet regulatory requirements.
84 Understanding SU final fill/ filtration process and collect key process parameters related validation tests from customer.
84 Understanding relationship of validation test design and process
84 SOPs of test rational & methodology for microbiology and chemical analysis or E&L
84 Drafting and reviewing protocols and reports
84 SU final fill and filters product knowledge
84 Tools application: SFDC/SP/KSS/TQF/ELN/LIMS/Report Generator/RISK tool/SOPs
61 Excellently managing multiple customers projects – from the order to the final report sending - simultaneously and bringing them to a successful completion as below strategy:
84 As leader to manage customer validation projects
84 on time and on promise within a timeframe communicated and agreed upon by the customer
84 with the right level of quality/regulatory compliance – ensuring that all operations are performed according to current EHS, good documentary practices, ISO standards, regulatory requirements and customer requirements stated in Agreements signed with them
84 Meeting customer needs and expectations thereby getting customer satisfaction at the highest level
84 at the right cost - ensuring that all project-associated costs (ex: samples preparations, eliminations, additional tests, appropriate level of support) are covered by customer’s order
84 tracking and analyzing data of team tasks like RFT and time of quotation, questionnaire, sample info, sending documentation, etc. to identify the place we can improve with corrective actions in the full-service process
61 Excellently leading each customer validation project to reach each milestone:
84 Cooperate with customer to complete quotation
84 Confirm process parameters to initiate project
84 Generating realistic project planning shared with customers, ensuring that, for each of them, the workflow is progressing at a steady rate, following up on tasks and activities, doing regular reviews of progress VS plan and proceeding with corrective actions to meet timelines, or readjust them when needed.
84 Driving a prioritization of customer projects and activities and allowing for streamlining Operations workload in alignment with Ops capacity to meet full utilization.
84 Deal with each issue related validation items as owner
84 Communicate NC and technical question with customer and sales
84 Push pending step to next as owner
84 Follow up business rule e.g., contract, invoice, cancel, payment
84 Creating, updating, tracking, and closing projects in SharePoint/SFDC accurately, completely, and contemporaneously.
84 Be sure all step executed within required time
61 As a proficient professional person to communicate internally and externally as below:
84 Guide customers to understand validation values and help customer to know about detail process information related to validation, to have a clear understanding to validation test methodology and documentation
84 Communication with customers and internal stakeholders on the price, lead time, technical topics, risk and conditions, regulatory views, market and competitor information
84 Interfacing between customers and validation services teams (quality and labs) to coordinate all activities (documentation, lab scheduling, test non-conformances).
84 Consulting VPM Manager, SME, Laboratory Manager and/or Global Support (GS) team members to obtain any required information and knowledge needed for project support and completion when necessary.
61 Proactively develop VS market and carry out marketing campaigns by working together with teams of sales, CA, Training, etc. Including:
84 Present validation services to customer and make the visit plan with customers and sales regularly.
84 Participate the GTM plan to present and promote validation services including WeChat, Webinars, Seminars and internal sharing, customer training course, etc.
84 Collect competitor information on the technical, documentation, process, price and lead time from market competitors, then conduct the analysis and response to customer when we face customer. Interact with global GS experts based on local information