Mondo
About the Role:
We are seeking an experienced Project Implementation Manager to oversee a portfolio of projects supporting growth initiatives, continuous improvement, and compliance programs. This role works closely with Corporate and Site Quality teams, as well as manufacturing, technical, engineering, and commercial functions. The ideal candidate has a strong background in regulated industries and excels at driving projects to completion on time, within scope, and within budget while ensuring compliance with FDA, cGMP, ISO, and other regulatory requirements.
Day-to-Day Responsibilities:
- Collaborate with internal and external stakeholders to define and plan project scopes, objectives, and deliverables.
- Develop detailed project plans, track progress, and ensure timely and successful delivery.
- Monitor project performance using appropriate systems, tools, and techniques; maintain documentation in product development tracking software.
- Identify, prioritize, and mitigate project risks while escalating roadblocks or challenges to senior management.
- Schedule, organize, and lead team meetings to assess progress against timelines and functional task lists.
- Ensure effective preparation and delivery of all project meetings, events, and milestone/tollgate reviews.
- Assist teams in preparing for milestone reviews to ensure readiness to advance to the next stage.
- Lead root cause and countermeasure processes to resolve issues related to scope, quality, timing, or budget.
- Drive compliance with applicable standards and regulations, including cGMPs, ICHQ7, IPEC, ISO, and FDA requirements .
- Perform other duties as assigned.
Must-Have Qualifications:
- Minimum of 5 years of experience in project management within a regulated industry (chemical, pharmaceutical, biotechnology, or related field).
- Formal project management training ; certification (PMP, PRINCE2, or similar) a strong plus.
- Experience in Quality, Regulatory Affairs, or IT systems development and program management.
- Strong knowledge of regulated environments, including GMP regulations, ISO9000, FDA 210/211, Part 11, and import/export regulations .
- Demonstrated ability to achieve results through cross-functional collaboration in a matrixed environment.
- Strong problem-solving and analytical skills with attention to detail.
- Excellent verbal and written communication skills; ability to engage effectively with stakeholders at all organizational levels.
- Proficiency with systems and software applications for project tracking and reporting.
Nice-to-Have Qualifications:
- Bachelor’s degree required; advanced degree preferred.
- Experience leading cross-functional projects in a global or highly regulated environment.
Benefits:
- This role is eligible to enroll in both Mondo's health insurance plan and retirement plan. Mondo defers to the applicable State or local law for paid sick leave eligibility.