Director​/Lead External Manufacturing

Company Description

At Dr Reddy's "Good Health Can't Wait"

By joining Dr Reddy’s, you will contribute to making the breakthroughs of tomorrow a reality today! From making medicines more affordable to discovering innovative treatment options to satisfy unmet medical needs, we are dedicated to helping people lead longer and healthier lives. We are seeking dynamic and energetic individuals ready to inspire, ready to make a difference for their community and every community.
Diversity, Equity & Inclusion
At Dr Reddy’s, we are deeply committed to building a diverse, equitable and inclusive workplace where everyone belongs and is valued for their contributions to the team. We are most interested in finding the best candidate for the role and are open to exploring candidates with a less traditional background.

We are seeking a Director / Lead External Manufacturing to lead operations for North America, to ensure reliable supply of commercial products and support new product launches. The position manages relationships with Contract Manufacturing Organizations (CMOs) and Contract Packaging Organizations (CPOs), driving operational excellence, compliance, and cost efficiency while collaborating with internal stakeholders across Quality, Supply Chain, Regulatory, Technical Services, and Commercial teams.

Responsibilities:

• 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 (EM) team members on a regular basis and communication of 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 & elevate 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

• Build and sustain strong partnerships and business relationship through effective alliance management with supply chain counterparts
• Negotiate and manage Master Supply/service agreements and ensure adherence to the terms and conditions of the contract agreement through collaborative partnerships.
• Communicate any inventory risks to EM inventory control, SCM and finance teams in a timely manner, and develop plan for risk mitigation of anticipated backorders at relevant CMO

• 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…