Manager, Operational Excellence

Hikma Pharmaceuticals USA Inc.•Cherry Hill, NJ

About The Position

Hikma Pharmaceuticals USA Inc. is seeking a Manager, Operational Excellence to drive operational excellence across sterile manufacturing operations. The role is responsible for ensuring processes are robust, compliant, scalable, and consistently executed, while providing strategic governance and performance oversight for manufacturing flows. It integrates continuous improvement with cGMP requirements and partners across functions to strengthen process capability, reduce performance risk, and maintain inspection readiness. Through leadership, data-driven decision-making, and disciplined execution, the role supports sustainable manufacturing performance and quality outcomes. The manager will own the end-to-end design, control, and performance of sterile manufacturing flows, including SDV, MDV, and PFS. The role will define and execute the site manufacturing excellence strategy, translate business and quality objectives into measurable improvement roadmaps, govern manufacturing KPIs, oversee manufacturing investigations, and serve as a subject matter owner during FDA and regulatory inspections. It will also lead and develop Manufacturing Excellence team members and work closely with Manufacturing, Quality, Validation, and Supply Chain.

Requirements

Bachelor’s degree in Industrial Engineering, Manufacturing Engineering, Chemical Engineering, Mechanical Engineering, or a related technical field.
At least 4 years of progressive experience in pharmaceutical manufacturing, operations, or operational excellence roles.
Ability to define and sustain a Manufacturing Excellence strategy aligned with business goals, quality objectives, and regulatory expectations.
Strong understanding of end-to-end sterile manufacturing flow design (SDV, MDV, PFS) and process governance.
Experience translating strategic objectives into actionable improvement roadmaps with measurable outcomes.
Proficiency using manufacturing and quality data analytics to drive decision-making and risk reduction.
Ability to interpret and trend KPIs such as Right-First-Time, OEE, deviation rates, yield, and CAPA effectiveness.
Skill in using dashboards, data visualization, and trend analysis to identify performance gaps and systemic issues.
Strong understanding of data integrity principles in a GMP environment.
Strong capability in structured problem-solving, root cause analysis, and risk-based decision-making.
Experience overseeing manufacturing investigations and ensuring systemic, sustainable CAPAs.
Ability to assess and manage risk related to process changes, flow modifications, and scale-up activities.
Proven ability to lead cross-functional teams across Manufacturing, Quality, Validation, MS&T, and Supply Chain.
Strong stakeholder management skills, including influencing without direct authority.
Ability to align technical, operational, and quality priorities into a unified execution model.
Experience leading and developing Operational Excellence, CI, and Data Analytics resources.

Nice To Haves

Lean Six Sigma Black Belt.
Master’s degree in Engineering, Operations Management, Business (MBA), or Quality.

Responsibilities

Own the end-to-end design, control, and performance of sterile manufacturing flows (SDV, MDV, PFS), ensuring processes are robust, compliant, scalable, and consistently executed.
Define and execute the site manufacturing excellence strategy, translating business and quality objectives into actionable improvement roadmaps with measurable outcomes.
Ensure operational excellence and improvement initiatives align with cGMP requirements, sterile processing standards, and internal quality systems.
Establish and govern manufacturing performance KPIs, including Right-First-Time, OEE, deviation trends, and CAPA effectiveness, and drive accountability through routine performance reviews.
Provide oversight and approval for manufacturing-related investigations, ensuring root causes are addressed systemically and corrective actions are effective and sustainable.
Serve as a primary subject matter owner during FDA and regulatory inspections for manufacturing performance, flow design, and continuous improvement effectiveness.
Partner with Manufacturing, Quality, Validation, and Supply Chain to align process design, execution, and compliance requirements.
Lead, coach, and develop Manufacturing Excellence team members, building technical depth, problem-solving capability, and quality ownership across the organization.

Benefits

Annual performance bonus, commission, and share potential.
Auto-enrollment in a Hikma-sponsored 401(k) at a pre-tax contribution rate of 3% of eligible pay; Hikma matches 100% of the first 6% of eligible pay contributed.
Paid time off starting with 20 days, prorated based on hire date, with additional days granted at work milestone anniversaries.
Three personal days, prorated based on hire date.
11 company-paid holidays.
Health, dental, vision, mental health, disability, life insurance, prescription drug coverage, and voluntary benefits.
Employee discount program.
Wellbeing rewards program.
Tuition reimbursement.
Paid maternity and parental leave.
Career advancement and growth opportunities.