External Manufacturing Operations Associate Director

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The role drives excellence in compliance, supply performance, continuous improvement, and cost management by leading and coaching cross-functional teams, partnering effectively with EPs, and applying MPS principles across the end-to-end supply chain. /ppJob Description The External Manufacturing Operations Associate Director (ExMOAD) is accountable for meeting customer demand at assigned External Partners (EPs).

The role drives excellence in compliance, supply performance, continuous improvement, and cost management by leading and coaching cross-functional teams, partnering effectively with EPs, and applying MPS principles across the end-to-end supply chain. /pulliLead the development and execution of Receiving Site Readiness risk management strategies, including project risk management plans and reports, systems hazard assessments, Failure Modes and Effects Analysis (FMEA), overall supply risk evaluations from launch through sustained supply, and risk control measures, while ensuring compliance with cGMP and other applicable standards. /liliCommercial supply readiness activities include planning and order management; sourcing for materials and equipment; EHS, compliance, and regulatory readiness; production and operations, including manufacturing, laboratories, warehouses, and utilities; shipping and logistics; and personnel readiness for both our company and External Partner teams. /liliLead teams to proactively anticipate, identify, and address technology transfer and manufacturing operations risks and challenges.

Communicate risk management strategies, manage escalations across Receiving Site Readiness functions, including DCT and PSM as appropriate to the product lifecycle, engage relevant governance forums, and align with External Partners. /liliLead scenario analysis and the development and execution of recovery plans, applying a probabilistic mindset to protect project timelines, deliverables, and supply continuity when emerging or unknown risks materialize. /liliLead issue management, escalation, and communication strategies to ensure timely communication of risks, issues, and mitigation plans within our company and with the External Partner, acting as the single point of contact. /liliUse data analytics, supply performance data, and signals from intelligence tools to inform supply risk management strategies and decisions through the Control Tower and other structured governance processes. /li /ulh3Primary Activities /h3ulliServe as the “Virtual Plant Manager” within ExM, overseeing our relationship with the External Partner. /liliCoordinate information flow and interactions between us and the External Partner through the Control Tower, while establishing clear boundaries and ways of working. /liliLead the cross-functional team, including Supply Chain, Quality, Technical Operations, and Procurement, to deliver daily, weekly, monthly, and annual requirements at assigned External Partner sites. /liliRemain accountable for all operational activities related to the assigned External Partner relationship. /liliOversee compliance, including quality risk management, deviation management, product release, and change control; demand fulfillment; dispute resolution and escalation; production planning; materials management, including MRP entries and logistics; technology issues; shop floor oversight; OpEx and continuous improvement; and end-to-end coordination with upstream, downstream, and Supply Chain Management teams to optimize material flow. /liliProactively drive risk assessment across the full value chain, working closely with the Focus Factory team and External Partner to manage and mitigate risks, prevent supply interruptions, and maintain full compliance with quality, environmental, health, and safety requirements. /liliMaintain frequent presence at External Partner sites, including on the production floor; build strong interdependent relationships with site leadership; assess and diagnose current conditions and risks using appropriate tools and resources; and partner with the External Partner and our cross-functional team to develop action-oriented, time-bound improvement plans. /liliPartner with ExM Procurement, ExM Quality, and ExM Technology on commercial relationship activities, including identifying, selecting, negotiating, renegotiating, or terminating agreements as required.

While transactional activities may be delegated to functional teams, the ExMOAD remains informed of status and resolutions. /liliRepresent ExM on cross-functional teams with SCM, Product Source Management, Procurement, and IDST during due diligence before and after siting approval.

Where required, ExM Operations may witness or certify destruction of goods to prevent counterfeiting. /liliAct as an MPS leader and coach for the team, working with the External Partner and MPS resources to identify OpEx and continuous improvement opportunities and support approved implementation plans. /liliLead periodic Business and Operations Review meetings with the External Partner.

In alignment with ours and ExM strategy, develop the annual Hoshin Kanri plan with the cross-functional team and External Partner, including clear goals and targets. ppJob Description The External Manufacturing Operations Associate Director (ExMOAD) is accountable for meeting customer demand at assigned External Partners (EPs).

Support SOS and NPI changes at External Partners, assume primary ownership of new relationships, and ensure plans include clear actions and timelines. /liliCollaborate with the External Partner to understand current and future capacity, including stated capacity, firm capacity, improvement opportunities, future capacity plans, and required lead times. /liliMaintain the integrity of the Master Supply Agreement (MSA), ensuring alignment with supply and quality agreements, appropriate document revision and distribution control, and execution of agreed contract terms, including purchase orders, forecasts, deliveries, and invoice approvals. /liliRemain accountable for inventory control and ensure appropriate documentation of material disposition based on whether goods are held at the External Partner or our company.

Prepare an annual relationship review that captures successes and challenges to share learnings across ExM. /liliLead strategic initiatives, including network actions, World Class Supplier activities, and Hoshin Kanri priorities. /liliContribute to the creation and maintenance of the External Manufacturing Organization Handbook, including global ExM policies, procedures, templates, and related resources. /li /ulh3Skills/Qualification /h3ulliBachelor’s degree in a related discipline preferred /liliCompliance – Demonstrated experience achieving compliance objectives through a risk-based approach, with strong knowledge of GMP, EHS, quality compliance, and compliance risk management.

Direct Health Authority audit experience is desirable. /liliWorld Class Supplier Mindset – Proven Lean Six Sigma capability to deliver compliant supply while improving quality, cost, and lead time. /liliBusiness and Financial Acumen – Ability to interpret and apply economic, financial, and industry data to make sound business decisions that create value for our company and its customers. /liliManufacturing Knowledge – Proven management-level expertise in relevant manufacturing modalities, such as API, drug product, or sterile operations. /liliStrategic Thinking – Ability to define a clear path forward, identify value-adding opportunities, and proactively mitigate risk across the value chain. /liliWorking Across Boundaries – Excellent interpersonal, communication, collaboration, and negotiation skills, with the ability to work effectively across organizational boundaries. /liliBusiness Outcomes and Results – Ability to apply deep production operations knowledge and expertise to deliver strong business outcomes. /liliEnd-to-End Mindset – Ability to apply an end-to-end supply chain perspective across internal and external networks and stakeholders to achieve results and support supply chain optimization. /liliMinimum of eight years’ experience in commercial, business, or manufacturing roles preferred, including operations, quality, technology, or planning, with a significant portion in management or leadership positions. /li /ulh3Required Skills /h3pAdaptability, API Manufacturing, Communication, Contract Management, Interpersonal Relationships, Operational Strategies, Production Planning, Product Lifecycle, Risk Assessments, Risk Based Approach, Risk Control, Safety Management, Strategic Thinking, Vendor Management /ph3Employee Status /h3pRegular /ph3Flexible Work Arrangements /h3pHybrid /ph3Job Posting End Date /h3p08/8/2026 /ppA job posting is effective until PM on the day BEFORE the listed job posting end date.

Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. /ph3Requisition ID /h3pR /p /p