Purpose External Supply Operations provides a strategic dimension to the manufacturing network to improve operational competitiveness and ensure uninterrupted global supply of medicines to patients.
In order to continue to provide the supplemental capacity to the manufacturing network, it is increasingly important that External Supply Operations establish consistent, robust processes and systems to ensure quality and supply reliability with our external contract manufacturing network while closely partnering with internal networks as well.
External Supply Operations is seeking a Strategic Planning & Operations Manager to join the Portfolio Strategy & Management (PSM) team.
This role will support the External Supply Operations organisation by leading NPIs and coordinating product transfers into the external manufacturing network, as well as advancing systems and processes related to Site Selections, Launches, and Technical Transfer Management.
This person will lead efforts that focus on joint team engagements, identifying and delivering on key project milestones, integrate external supplier functions with company processes, provide recommendations to drive pivotal initiatives, business performance and operational improvements.
The Manager is responsible to stay informed of standard methodologies and provide innovative, impactful ideas to optimise processes to support the organisation's growth strategies.
The successful candidate will lead multiple NPIs, projects and initiatives that advance External Supply Operations strategies, goals and objectives.
Responsibilities Responsible for leading new product introduction activities for new launches or programs tech transferring into CMOs Provide project strategic direction of external manufacturing technical transfer and new product introduction activities coordinating execution of cross-functional workstreams from Quality, Process Development, Contracts, Supply Chain, Analytical Sciences and Global Strategic Sourcing.
Execution and adherence to PSM NPI business processes and operating model Strong interpersonal skills as interactions will be both internal and external facing with CMOs and Executive leadership.
Lead multiple cross-functional projects of medium to high complexity.
Build and maintain project plans and team assignments using project planning tools, estimating project cost and adhering to budget, directing and supervising work efforts on daily basis, identifying resource needs, performing project reviews, and advancing functional, quality, timeline and cost issues appropriately.
Understand and react to project risks, scope changes, industry trends and influences.
Utilise project management processes, software and methodologies to ensure projects are delivered on time, within budget, adhere to high quality standards and meet customer expectations.
Handle communication with all areas of the enterprise that impact scope, budget, risk and resources of the work being managed and provide project updates and reporting to executive leadership and internal partners.
Lead continuous improvement projects that deliver measurable gain in quality, efficiency and alignment within project priorities.
Apply the knowledge, skills, tools of project management and operational perfection to ensure efficient execution of projects and continuous improvement initiatives.
Basic Qualifications: Doctorate degree OR Master's degree and 2 years of solid experience within a c GMP manufacturing or quality environment OR Bachelor's degree and 4 years of solid experience within a c GMP manufacturing or quality environment OR Associate's degree and 10 years of solid experience within a c GMP manufacturing Preferred Qualifications: Strong organisational and cross-functional project management skills Strong technical background with understanding of pharmaceutical manufacture and commercialisation High ethical business standards, fosters inclusively and promotes diversity Demonstrated accountability to deliver results and meet deadlines while handling contending priorities Problem-solving, critical thinking and decision-making skills Strong interpersonal, listening and customer service skills Strong presentation abilities, oral and written, including confidence and decisiveness when engaging with Senior Management and customers Experience managing and influencing in a matrix organisation Manufacturing and c GMP knowledge and experience Strong negotiation skills Operational Excellence proficiency Understanding of contractual requirements Technical writing and multi-level presentation skills Experience leading effectively in collaborative team environment Ability to take initiative, drive action and work under minimum supervision Proficiency in Microsoft Office especially Project, Excel, Power Point, Visio, Smartsheet and Think Cell