Project Manager, Transformation & Continuous Improvement
About The Position
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.
Requirements
- 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.
- 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.
Nice To Haves
- Lean Six Sigma Black Belt or equivalent certification preferred.
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.
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What This Job Offers
Job Type
Full-time
Career Level
Manager
Number of Employees
1,001-5,000 employees
