External Manufacturing Operations Associate Director

Compliance – 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.

World Class Supplier Mindset – Proven Lean Six Sigma capability to deliver compliant supply while improving quality, cost, and lead time.

Business 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.

Manufacturing Knowledge – Proven management-level expertise in relevant manufacturing modalities, such as API, drug product, or sterile operations.

Business Outcomes and Results – Ability to apply deep production operations knowledge and expertise to deliver strong business outcomes.

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.

The ExMOAD is responsible for supply assurance and commercial supply risk management across the following areas:

Lead 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.

Commercial 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.

Lead teams to proactively anticipate, identify, and address technology transfer and manufacturing operations risks and challenges.