Director, Outsourced Manufacturing

Director, Outsourced Manufacturing

Gilead

Cork, Ireland

This position is responsible for the supplier relationship and performance management of assigned commercial drug product contract manufacturing organizations (CMOs). This position coordinates between all relevant Gilead 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 Sr. Director and in conjunction with Commercial Manufacturing, Analytical Operations, Quality, Development and other Gilead functions, as needed. This position will lead the respective CMO Management Teams for assigned CMOs and support implementation and execution of CMO initiatives as part of the larger Gilead 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 CMOs and will lead the resolution of supply issues and risk mitigation at respective CMOs. This person will support Gilead Supply Chain Management in the development of supply mitigation plans with CMOs in response to critical supply issues. Assigned CMOs are expected to be primarily located in Europe.

Essential Duties and Job Functions:

  • Serve as the primary day to day contact to support the relationship between Gilead and assigned CMOs;
  • Serve as the production champion/point of contact (POC) with assigned CMOs to manage and mitigate issues and drive robust supply of product through coordination across commercial functions;
  • Manage external manufacturing activities and relationships. Serve as the day to day internal representative for CMO management at assigned CMOs;
  • Execute strategies that drive effective operational performance and service levels at CMOs. Strong alignment with Supply Chain, Commercial Manufacturing, and Quality is required;
  • Lead initiatives that drive a collaborative and robust relationship and drive alignment between CMOs and Gilead 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 Gilead;
  • Utilize analytical tools to identify, quantify, and minimize risks at assigned CMOs;
  • Negotiate and manage key CMO agreements (MSAs, SOWs, Supply Agreements, Pricing, etc.);
  • Implement and manage joint operating procedures between Gilead 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 Gilead’s manufacturing requirements. Develop relationships with potential COs that support Gilead’s 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.

Knowledge, Experience, and Skills:

  • 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 organization;
  • An independent self-starter with the ability to resolve supplier performance challenges and implement process and/or system improvements;
  • Ability to develop, analyze, and leverage key metrics to improve overall business performance;
  • Proven ability to problem solve, build strong relationships, and to organize 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.

Typically Requires:

  • BA/BS with 10+ years of relevant experience in a related field; or
  • MBA or MS plus 8+ years of relevant experience in a related field;
  • Prior experience managing contract manufacturing highly desirable;
  • Prior experience in pharmaceutical operations and cGMP environment(s) highly desirable;
  • Travel required – up to 25%.

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© EuroJobsites 2020

EuroJobsites is a registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

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