Operations Transformation Manager (“Department Reset Leader”)
About The Position
SriSai Biopharmaceutical Solutions (SBS) is seeking a top‑tier regulated operations leader to execute a full reset of warehouse, inventory, shipping, receiving, and P&L‑linked operational processes. This is a turnaround and transformation mandate, not a maintenance role. The ideal leader brings deep GMP/GxP experience, proven audit‑facing strength, and a track record of stabilizing broken operations, building accountable teams, and leading organizations through electronic system implementation (WMS, ERP, eQMS, client portals, barcoding, labeling). This role is responsible for eliminating chronic operational gaps, enforcing SOP‑driven execution, strengthening compliance, and building a durable frontline leadership bench. Within 6–9 months, this leader is expected to deliver measurable KPI improvements and significantly reduce the need for executive intervention.
Requirements
- 10+ years progressive operations leadership in regulated life sciences, biopharma, biotech, or clinical environments.
- 5–7+ years managing supervisors or multi‑function operational teams.
- Demonstrated success leading turnaround or transformation initiatives.
- Hands‑on experience implementing or upgrading WMS/ERP/eQMS systems.
- Strong audit‑facing capability within GMP, GxP, or ISO frameworks.
- Proven ability to translate SOPs into operational processes and training.
- Strong analytical capability with KPI‑driven performance management.
- Bachelor’s degree required
Nice To Haves
- Master’s or Lean Six Sigma preferred.
Responsibilities
- Lead supervisors and functional leads across receiving, inventory control, shipping, and P&L‑linked activities.
- Establish clear ownership for each operational function and shift (including nights/weekends).
- Implement structured daily management: dashboards, huddles, KPIs, and escalation paths.
- Diagnose systemic breakdowns and implement sustainable corrective actions.
- Reduce overtime through disciplined scheduling, cross‑training, and capacity planning.
- Ensure consistent execution of pre‑shipment checks, receiving workflows, and inventory movements.
- Serve as the operational authority on GMP/GxP SOP interpretation and execution.
- Translate SOPs into floor‑ready workflows, checklists, and training materials.
- Partner with QA to close compliance gaps before audit exposure.
- Strengthen documentation integrity across receiving, shipping, and inventory.
- Ensure chain‑of‑custody, access control, and traceability for all materials.
- Lead operational preparation for client audits, regulatory inspections, and CAPA follow‑through.
- Lead operational requirements for WMS, ERP, receiving modules, inventory modules, and client portal.
- Drive transition from Excel/email‑based tracking to real‑time electronic visibility.
- Ensure validation, SOP alignment, and competency training for all system rollouts.
- Build dashboards for throughput, accuracy, backlog, space utilization, and labor efficiency.
- Partner with IT and QA to ensure system integrity, data accuracy, and audit‑ready configuration.
- Establish disciplined cycle counting, reconciliation, and discrepancy management.
- Implement full mapping of rooms, freezers, shelves, and storage locations.
- Reduce lost/mis‑tracked materials through access control and chain‑of‑custody enforcement.
- Improve space utilization and support capacity planning for growth.
- Ensure inventory data flows cleanly into billing, client reporting, and leadership dashboards.
- Eliminate errors in shipments, counts, labeling, and client‑specific requirements.
- Ensure timely receiving, inspection, documentation, and QA approvals.
- Improve client communication and shipment visibility through system integration.
- Reduce rework and client complaints through disciplined pre‑shipment and receiving checks.
- Ensure accurate time coding, labor allocation, and operational cost visibility.
- Partner with Finance to align operational workflows with billing requirements.
- Improve accuracy of space reporting, storage billing, and client-specific charges.
- Support development of operational P&L visibility by department and client.
- Develop supervisors into accountable, data‑driven operational leaders.
- Address performance issues decisively and professionally.
- Build a cross‑trained, resilient team capable of covering all shifts and functions.
- Reinforce a culture of ownership, discipline, and compliance.
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What This Job Offers
Job Type
Full-time
Career Level
Manager
