Website:
umendrals.com
Job details:
About Us
Umendra Life Sciences Pvt. Ltd. is a pharmaceutical manufacturing company specialising in topical formulations, including creams, ointments, gels, lotions and other external-use products.
Our manufacturing facility in Bavla, Ahmedabad, serves international markets, with a significant focus on the United States.
As we continue to strengthen and expand our operations, we are seeking an accomplished Plant Head / Site Head to take complete responsibility for our manufacturing facility.
We are looking for a proven pharmaceutical manufacturing leader who can take end-to-end ownership of an entire manufacturing facility - its people, processes, performance and regulatory compliance.
This is a senior leadership position requiring someone who has already successfully managed a US FDA-regulated pharmaceutical manufacturing plant.
Mandatory Qualifications & Experience
- Bachelor's degree in Pharmacy, Engineering, Science or a relevant discipline.
- Minimum 15 years of experience in pharmaceutical manufacturing.
- Proven experience as Plant Head / Site Head with complete responsibility for an entire pharmaceutical manufacturing facility.
- Prior experience managing a US FDA-regulated pharmaceutical manufacturing plant is mandatory.
- Demonstrated experience leading multiple functions, including Production, Quality, Engineering and Warehouse.
- Strong understanding of US FDA cGMP regulations, pharmaceutical quality systems and regulatory inspection requirements.
- Proven track record of operational improvement, people leadership and organisational development.
Preferred Experience
- Manufacturing experience involving topical pharmaceuticals, semisolids, creams, ointments, gels or OTC formulations.
- Experience managing US FDA inspections and international customer audits.
- Experience leading operational transformation, capacity expansion or organisational restructuring.
- Experience with manufacturing operations supplying the US market.
Key Responsibilities
Overall Plant Leadership
- Assume complete responsibility for plant operations, performance and administration.
- Lead all site departments, including Production, QA, QC, Engineering, Warehouse, HR, Administration and EHS.
- Establish clear accountability, reporting structures and performance expectations across departments.
- Ensure effective cross-functional coordination and timely resolution of operational challenges.
- Serve as the single point of accountability for overall plant performance.
Operational Excellence
- Drive manufacturing efficiency, productivity, capacity utilisation and cost optimisation.
- Ensure production targets, delivery commitments and operational KPIs are consistently achieved.
- Identify systemic operational weaknesses and implement sustainable corrective measures.
- Establish robust planning, performance monitoring and management review systems.
- Lead continuous improvement initiatives across manufacturing and supporting functions
Quality & Regulatory Compliance
- Ensure adherence to applicable US FDA cGMP requirements and other relevant regulatory standards.
- Maintain a continuous state of regulatory inspection readiness.
- Provide leadership oversight of quality systems, including deviations, CAPAs, change controls, documentation and data integrity.
- Ensure timely and effective resolution of regulatory observations and customer audit findings.
- Foster a strong quality culture while preserving the Quality Unit's independent authority over product quality and release decisions.
People & Organisational Leadership
- Lead, mentor and develop departmental heads into an effective and accountable management team.
- Establish a performance-driven culture built on professionalism, discipline and ownership.
- Identify organisational capability gaps and implement development and succession plans.
- Strengthen interdepartmental communication and organisational effectiveness.
- Build systems that enable consistent performance and reduce dependence on individual intervention.
Infrastructure & Strategic Development
- Oversee engineering, maintenance, utilities, infrastructure and plant reliability.
- Identify opportunities for technological advancement, automation and capacity expansion.
- Lead plant-level strategic initiatives and operational improvement projects.
- Present structured performance reviews and improvement plans directly to the Directors.
This opportunity is intended for experienced Plant Heads who have already demonstrated successful leadership of a complete pharmaceutical manufacturing facility.
Click on Apply to know more.