Senior External Manufacturing Lead – Supply & Compliance

Lead Associate / Senior Manager External Manufacturing

Lead operations for North America to ensure reliable supply of commercial products, support new product launches, manage relationships with Contract Manufacturing Organizations (CMOs) and Contract Packaging Organizations (CPOs), and drive operational excellence, compliance, and cost efficiency while collaborating with internal stakeholders across Quality, Supply Chain, Regulatory, Technical Services, and Commercial teams.

• Coordinate with CMOs/CPOs to ensure on-time, in-full (OTIF) delivery of cGMP compliant
  , and quality reviewed and released FG and Bulk drug products to customers and markets
• Determine supply priorities through interaction with the Global Supply chain and External Manufacturing team members on a regular basis and communicate these priorities and changes to the relevant CMO/CPO
• Understand CMO’s capacity constraints
  , bottlenecks, material shortages, etc. in the short, medium and long term, aid resolution of these constraints & escape to the supply chain management as needed
• Manage the commercial product lifecycle, including raw material changes, artwork updates, process revalidations, packaging changes, and shelf‑life extensions
• Prepare and provide accurate monthly forecasts, purchase orders, and stock‑transfer orders to the CMO’s manufacturing sites in‑order to meet forecasted demand and target inventory/MOH levels
• Lead/participate in cross‑functional due diligence teams to assess new business opportunities and potential capabilities of a new CMO
• Review, approve, and submit CMOs invoices for timely payments

• Ensure all compliance‑related documents, such as batch records, COC/COA, etc., for each order are accurate and available for Quality Assurance review and release
• Arrange permits, state licenses, quality agreements, and service agreements to maintain GMP/GDP compliance
• Review of CMO related change controls to understand the supply chain impact; work closely with QA, regulatory, commercial and packaging teams to facilitate risk assessment & impact, along with approval process for the changes proposed/implemented at the CMO
• Ensure the complete set of shipping documents is provided by the CMO/CPO including packing list, commercial/custom invoice, certificate of origin, BOL/AWB/HWB, EPICS file and all approved copies of COC’s and COA’s at the time of shipment

• Facilitate set up and validate material and vendor master data in SAP and related systems
• Support the entire order‑to‑commercial cycle with proactive issue resolution
• Liaison and support DSCSA compliance and serialization requirements with CMO’s Serialization team, collaborate with internal IT, and 3PL warehouse to ensure complete and timely implementation of GS1 EPCIS process to meet FDA requirements for new product launches and CMO’s on‑boarded

• Lead cost optimization projects with partners to improve throughput and efficiency
• Drive initiatives to mitigate supply chain risks and enhance operational resilience
• Participate and drive Alternate Vendor Development (AVD) projects for evaluating and validating new API, excipients and RM vendors for dual‑sourcing, cost savings and reliability optimization

• Postgraduate degree with specialization in Operations Management, Supply Chain Management or related field

• 5‑10 years of experience in cGMP pharmaceutical manufacturing or supply chain operations

• Proven experience in contract manufacturing management in an international environment
• Strong operational expertise in pharmaceutical supply chain and generics business model
• Proficiency in SAP, MS Office, and MS Project
• Demonstrated ability to work with urgency, meet timelines, and ensure compliance
• Excellent leadership and relationship‑building skills across multicultural, multilingual environments
• Strategic thinking with strong execution capability
• Negotiation and alliance management skills
• Problem‑solving and proactive risk mitigation
• Ability to influence across functions and geographies

Incumbent must be a U.S. citizen…