Technical Projects Integration Manager (Port Elizabeth) at Aspen Pharma Group

Overview

The purpose of this role is to manage the integration of technical projects across the Aspen SA Operations
with high focus on technical sterile products. The role is required to apply expert functional knowledge and experience within Steriles particularly, to provide optimal project delivery. It is also responsible for taking cost saving, technical transfer and regulator-initiated projects and converting them into relevant product supply,
through designing and executing project plans, as well as developing and managing budgets and all aspects
of project scope, timelines, cost, resolving quality related issues and ultimately ensuring technical transfer
success.

Responsibilities

Manage the technical transfer process, according to the relevant department procedures and SOPs, from initiation to completion

•  Facilitate processes which include feasibility, planning scoping and initiation of new projects and related budgets. 
•  Manage the process of sourcing, compiling, controlling, and distributing relevant information from the sending site into the Donor site Data Pack (DSDP) and circulating to respective technical and regulatory teams
•  Manage the formal documentation associated with the technical project process as per the SOP (PID; TPSD, RPSA; PVSA; CMR; TTP, PTF; etc.); track the approval of the documents
•  Manage the CTD Data Pack process of compiling, controlling, and distributing Tech site submission information to regulatory compliance teams
•  Manage delivery of site technical project plans and generate overall timeline from project initiation to first supply for review by sponsors and stakeholders
•  Handover of project once the technical process is complete, under the guidance of the project sponsor

Management of overall project costs and budget

•  Direct site for technical feasibility assessment and generating quotations on project costs; share costs
• with finance / PMO teams to run Business case evaluations
•  Management of the various service providers, challenging the costs, benchmarking quotes & ensuring billing on time.
•  Manage project budget through the project budget management process, including decisions on
• approval of forecasted expenditure and assessing impact of scope and timeline changes on yearly and overall project budget

Collaborate & communicate with all stakeholders to ensure successful implementation of project metrics 

•  Manage Project meetings including kick off, close out, weekly progress and ad hoc technical meetings with ownership of agendas, minutes & action item repository 
•  Provide monthly status updates for projects to facilitate the monthly dashboard reporting, quarterly Board reports and risk registers
•  Assist SA Operations’ procurement by providing information required to source quotes for components / raw materials or alternate material sources
•  Manage technical queries/issues between sending and receiving sites and act as Product SME when in house expertise is not available
•  Troubleshoot process problems, Support sites with Root cause investigations, writing of reports and closing CAPA’s 
•  Manage project risks and escalate significant changes in timelines to manager 
•  General project communications keeping stakeholders informed and directing daily workflow across sites
•  Provide Technical inputs into Site and Project Portfolio Steercom meetings
• Provide support to Regulatory teams to ensure submission timelines, Requests For Information (RFI’s) and technical related queries are actioned within the stipulated timelines
•  Manage technical queries from supply and Regulatory hubs and support strategies concerning submission. Provide review of compiled dossier sections
•  Manage responses and closure of RFI’s from regulators by directing and coordinating site responses and authoring justifications where relevant
• Deliver SA Operations’ KPI’s though successful completion of critical milestones associated with project plans and meeting scheduled implementation dates within defined budget
•  Apply expert functional knowledge and experience to provide optimal project delivery
•  Risk mitigations to prevent impacts on timeline and cost

Sterile Subject Matter Expert (SME)

•  Aseptic and terminal sterilized products, (solutions, emulsions, lyophilized products, 
•  Primary packaging componentsxxx

Ad Hoc / Specific Activities

•  Keep abreast of latest technical developments and GMP requirements
•  Provide support / assistance to other Project managers at SA Operations, as and when required

Requirements
Skills Required
Background/experience

•  Bachelor’s degree in engineering
•  Formal Project Management (PMP) certification 
•  5 – 10 years’ experience in the pharmaceutical environment dealing with sterile product dosage forms
•  5 years’ relevant project management experience
•  Working knowledge of pharmaceutical standards / compliance 
•  High technical expertise in sterile products: process, sterilisation, materials and primary
•  packing components 
•  Extensive knowledge of working on start-up technical projects within highly regulated environments

Specific job skills

•  Pharmaceutical industry work experience in a manufacturing facility
•  Pharmaceutical supply chain, regulatory, laboratory and quality knowledge preferable 
•  Core knowledge of pharmaceutical manufacturing, GMP and quality (Deviation classification and justification) and technical transfer (ISPE)
•  Report writing 
•  Budget development and management 
•  Sound knowledge of IT, Excel, Word, MS Projects, Power Point, Dashboards

Competencies

•  Multi-tasking
•  Focused
•  Leadership
•  Teamwork
•  Cooperation
•  Proactive
•  Risk Management
•  Responsibility & Accountability
•  Problem solving and good judgement