- Company Name
- Coda Search│Staffing
- Job Title
- Project Implementation Manager
- Job Description
-
**Job Title:** Project Implementation Manager
**Role Summary:**
Leads cross‑functional projects in a regulated life‑science environment, ensuring delivery on schedule, within scope and budget, while meeting cGMP, ICH, ISO and FDA compliance requirements. Coordinates internal teams and external vendors, monitors progress, manages risks, and drives issue resolution through structured governance.
**Expectations:**
- Deliver project portfolios on time, on budget, and in compliance with all regulatory standards.
- Maintain accurate project documentation and status reporting in product development tracking tools.
- Communicate risks, issues, and milestones clearly to senior leadership.
- Foster collaboration across quality, manufacturing, engineering, IT, and commercial functions.
**Key Responsibilities:**
- Define project scopes, objectives, and detailed plans with stakeholders.
- Track and report project performance using appropriate tools; update tracking software regularly.
- Schedule, facilitate, and lead team meetings, tollgate/milestone reviews, and risk mitigation sessions.
- Identify, prioritize, and mitigate project risks; implement corrective actions as needed.
- Ensure preparation and delivery of all required documentation for each project phase.
- Lead root‑cause analysis and countermeasure development to address scope, quality, timing, or budget issues.
- Coordinate internal resources and third‑party/vendors throughout project lifecycle.
- Escalate challenges to senior management promptly and propose solutions.
**Required Skills:**
- Proven project management experience (≥5 years) in regulated chemical, pharmaceutical, or biotech environments.
- Strong knowledge of cGMP, ISO 9000, ICH Q7, FDA 21 CFR 210/211, Part 11, and import/export regulations.
- Proficiency with project management software and IT systems used for product development tracking.
- Excellent analytical, problem‑solving, and detail‑orientation abilities.
- Superior written and verbal communication skills; ability to influence at all organizational levels.
- Ability to work effectively in a matrixed, cross‑functional team setting.
**Required Education & Certifications:**
- Bachelor’s degree in Business, Project Management, Engineering, Science, or related field (advanced degree preferred).
- Project Management training; PMP, PRINCE2, or equivalent certification preferred.
- Additional certifications in Quality, Regulatory Affairs, or related disciplines are a plus.
Phillipsburg, United states
On site
Mid level
18-09-2025