Associate Director - Outsourced Manufact

ICDS RECRUITMENT

CORK

Associate Director - Outsourced Manufacturing: Cork. In this role you will be responsible for the supplier relationship and performance management of assigned commercial drug product contract manufacturing organisations (CMO's). This position co-ordinates between all relevant company functions and CMO functions to ensure strategies and supply plans are executed and achieved as planned. This includes driving performance of the strategic relationship under the direction of the department Senior Director and in conjunction with Commercial Manufacturing, Analytical Operations, Quality, Development and other functions, as needed. This position will lead the respective CMO Management Teams for assigned CMO's and support implementation and execution of CMO initiatives as part of the larger CMO governance model. This person will work with CMO management to measure and drive results and initiatives, and to develop and maintain collaborative relationships. This position will also serve as the production champion for assigned CMO's and will lead the resolution of supply issues and risk mitigation at respective CMO's. This person will support Supply Chain Management in the development of supply mitigation plans with CMO's in response to critical supply issues. Assigned CMO's are expected to be primarily located in Europe. Core Duties and Job Functions: Serve as the primary day to day contact to support the relationship between the company and assigned CMO's. Serve as the production champion/point of contact (POC) with assigned CMO's to manage and mitigate issues and drive robust supply of product through co-ordination across commercial functions. Manage external manufacturing activities and relationships. Serve as the day to day internal representative for CMO management at assigned CMO's. Execute strategies that drive effective operational performance and service levels at CMO's. Strong alignment with Supply Chain, Commercial Manufacturing, and Quality is required. Lead initiatives that drive a collaborative and robust relationship and drive alignment between CMO's and the company including but not limited to: Business reviews, Performance Metrics, Continuous Improvement projects, and Risk Management. Support and effectively execute CMO Management initiatives and cross-functional efforts, processes and strategies to ensure supply performance is achieved, both at the CMO and within the company. Utilise analytical tools to identify, quantify, and minimize risks at assigned CMO's. Negotiate and manage key CMO agreements (MSAs, SOWs, Supply Agreements, Pricing, etc.) Implement and manage joint operating procedures between the company and the supplier/CMO to ensure effective execution. Report metrics and lead supplier specific performance improvement initiatives. Understand the CMO market and capabilities that are consistent with manufacturing requirements. Develop relationships with potential CMOs that support future CMO needs. Coordinate interdepartmental activities with Quality Assurance, Manufacturing, Development and other functions that support commercial supply. Work closely with department management to establish standards and policies that support key CMO/supplier partnerships. Interested applicants should have: Ability to influence and work well with others in a proactive and constructive manner. Strong communication skills, both verbal and written, with all levels of an organisation. An independent self-starter with the ability to resolve supplier performance challenges and implement process and/or system improvements. Ability to develop, analyse, and leverage key metrics to improve overall business performance. Proven ability to problem solve, build strong relationships, and to organise effectively. Business acumen with an ability to anticipate operational issues and proactively recommend mitigations/solutions. Expertise in domestic and international cGMPs. Demonstrated ability to multi-task and to work across multiple multi-national sites and diverse cultures. BS degree in related field required. Advanced degree including MBA or MS preferred. Familiarity with ERP and supply chain systems a plus. At least 8 to 10 years' relevant experience in a related field. Prior experience managing contract manufacturing highly desirable. Prior experience in pharmaceutical operations or other life science sectors and cGMP environment(s) highly desirable. Travel required – up to 25%.

1352 days ago