Senior Production Manager

The Manufacturing Operations Lead is accountable for  safe, compliant, and efficient delivery of production volumes  across assigned dosage forms, while building a  high-integrity, high-rigor manufacturing organization . The role carries end-to-end responsibility for  batch execution discipline, cycle time adherence, OEE improvement, people capability development, and sustained quality compliance  in a USFDA-regulated environment.

1. Production Delivery & Operational Excellence
Own  achievement of approved production plans  (volume, mix, and timelines) with clear accountability for  Right-First Time (RFT)  execution.
Ensure strict adherence to  batch cycle times, changeover times, cleaning times, and line utilization norms  as per approved standards.
Drive continuous improvement in  Overall Equipment Effectiveness (OEE)  across availability, performance, and quality metrics.
Ensure disciplined execution of manufacturing instructions, line clearances, in-process controls, and documentation practices.
Proactively identify and eliminate bottlenecks impacting throughput, yield, or schedule adherence.
2. Quality, Compliance & Inspection Readiness
Maintain a  state of continuous GMP compliance  in line with USFDA, EU GMP, and internal quality standards.
Be fully accountable for  deviation trends, CAPA effectiveness, repeat observations, and human-error reduction  within manufacturing.
Partner closely with Quality Assurance to ensure  robust batch release readiness  and zero compromise on data integrity.
Lead manufacturing readiness for  regulatory inspections, customer audits, and internal audits , including sustained closure of commitments.
Reinforce a culture of  “Quality over output when in conflict”  without dilution of delivery commitments.
3. People Leadership & Capability Building
Build and sustain a  strong manufacturing leadership bench  (production managers, shift leaders, supervisors).
Ensure structured  skill development, qualification, and certification  of operators and officers on equipment, processes, and GMP behaviours.
Drive  performance management, succession planning, and talent retention  within manufacturing teams.
Set clear expectations on  discipline, ownership, accountability, and ethical conduct  at all levels.
4. Behavioural Integrity & Cultural Rigor
Act as a role model for  Rubicon’s values of Integrity, Passion, Agility, and Solidarity .
Enforce  zero tolerance  for data integrity lapses, undocumented practices, or shortcut behaviours.
Create a culture where issues are  surfaced early, investigated scientifically, and resolved sustainably .
Ensure respectful, transparent, and fact-based engagement across cross-functional teams.
5. Digitization & Special Projects
Lead and support  digitization initiatives  within manufacturing, including electronic batch records, MES interfaces, equipment data capture, and performance dashboards.
Drive  qualification, commissioning, and validation  of new equipment, lines, and manufacturing technologies in collaboration with Engineering and QA.
Support scale-up, tech transfer, and capacity expansion projects with strong operational ownership.
Champion data-driven decision-making using real-time production, quality, and OEE analytics.
6. Be accountable for  manufacturing-led Exhibit Batch Completion , including:
Accuracy and completeness of batch records
Resolution of execution-stage discrepancies
Timely initiation and closure of deviations arising during execution
Partner with QA to ensure  right-first time exhibit batches , minimizing QA queries, rework, and review loops.
Ensure exhibit batches are  inspection-defensible , with clear traceability, contemporaneous documentation, and ALCOA+ compliance.

Must-Have

Skills:

List at least 3 points that are necessary to be successful in the role. Points for reference:
Degree in Pharmacy / Chemical Engineering / Mechanical Engineering or equivalent.
15+ years of progressive manufacturing leadership experience in  USFDA-regulated pharmaceutical environments .
Proven track record of  high-volume manufacturing with strong compliance outcomes .
Hands-on experience with  digitization, equipment qualification, and operational excellence frameworks.
Problem solving and decision-making ability
Excellent communication skills and stakeholder management skills

Key Interfaces
Quality Assurance & Quality Control
Engineering & Projects
Planning & Supply Chain
EHS
Corporate Operations Excellence / Digital Transformation Teams
Success Measures (KPIs)
Production plan adherence (% on-time, in-full)
Batch cycle time and cleaning time adherence
OEE improvement trends
RFT and deviation reduction metrics
Inspection outcomes and audit closure effectiveness
Attrition, capability depth, and leadership readiness in manufacturing teams