Job Description

Our Work Matters

At Kindeva we make products that save lives, ensuring better health and well-being for patients around the world.

The Impact You Will Make

The Program Manager, Transformation & Continuous Improvement, is responsible for leading large-scale strategic and cross-functional improvement programs within the Sterile CDMO network. This role drives transformation initiatives that enhance manufacturing capability, quality performance, and operational efficiency across aseptic processing, fill-finish, and packaging operations. The position ensures alignment with corporate and site-level objectives, fosters a culture of continuous improvement, and delivers sustainable performance through structured problem-solving, project management excellence, and effective change leadership.

Role Responsibilities:

Execute and manage continuous improvement initiatives across sterile manufacturing and fill-finish operations. Lead site-level transformation and continuous improvement projects across manufacturing, quality, supply chain, and supporting GMP functions. Apply Lean, Six Sigma, DMAIC, and PDCA methodologies to drive operational excellence and reduce variability in sterile manufacturing. Utilize Lean tools such as 5S, standard work, and visual management to improve efficiency and consistency. Track project progress, report KPIs, and ensure documentation of improvement outcomes. Partner with QA, MS&T, Engineering, Supply Chain, and Finance to optimize process reliability, equipment readiness, and compliance with GMP standards. Support regulatory readiness and ensure transformation initiatives enhance inspection preparedness and quality system maturity. Contribute to audit readiness and GMP compliance improvement efforts. Promote a data-driven culture of continuous improvement, innovation, and disciplined execution.

Qualifications:

Bachelor's Degree in Engineering, Life Sciences, Business, or related field Minimum 5 years of experience in pharmaceutical manufacturing, including significant experience in sterile/aseptic operations. Experience in CDMO environments preferred. Demonstrated success leading transformational or operational excellence programs in GMP-regulated industries. Strong knowledge of aseptic processing, regulatory compliance (FDA/EMA), and risk-based decision-making. Lean Six Sigma Black Belt or equivalent certification preferred. Proven experience influencing cross-functional teams and senior leadership. Excellent communication, facilitation, and program management skills. Proficiency in data analytics and visualization tools to drive performance-based decision-making.

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Equal Opportunity Employer:

Kindeva Drug Delivery is an Equal Opportunity/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, Protected Veteran status, sexual orientation, or any other characteristic protected by federal, state or local law.



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