Job Description
Job Title: Project Implementation Manager
Location: Paris, KY
Pay: $43.00 to $48.00 hourly
This is a TEMP TO PERM position for a biopharmaceutical company. APPLY NOW
Job Description Summary:
The Project Implementation Manager works closely with members of the Corporate and Site Quality teams as well as manufacturing, technical, engineering, and commercial functions as required. The Manager is accountable for a portfolio of projects supporting growth initiatives and continuous improvement activities. Projects may involve new production or testing capacity, product transfers, customer qualification & support, internal process improvements, and compliance-related programs. The Manager coordinates internal resources and/or third parties/vendors for project development, planning, and execution, ensuring projects are completed on time, within scope, within budget, and in compliance with regulatory requirements such as cGMPs, ICHQ7, IPEC guidelines, ISO regulations, and FDA requirements.
Essential functions:
- Collaborate with stakeholders internally and externally to develop and plan project scopes and objectives.
- Develop detailed plans to track and monitor progress, ensuring successful project delivery.
- Measure project performance using appropriate systems, tools, and techniques, and document all project-related information.
- Communicate project challenges or roadblocks to senior management through proper escalation.
- Lead team meetings to assess progress against tasks and timelines.
- Identify, prioritize, and mitigate project risks.
- Prepare and deliver all project documentation and ensure readiness for project milestones.
- Participate and/or lead tollgate/milestone meetings to assess progress and readiness to proceed.
- Lead root cause/countermeasure processes to address scope, quality, timing, or budget issues.
- Perform other duties as assigned.
Minimum requirements:
- Experience managing projects and programs; Project Management certification is a plus.
- Experience in Quality, Regulatory Affairs, or IT systems, and managing related programs.
- Bachelor's degree; advanced degree preferred.
- Minimum of 5 years in the regulated industry or related role within the chemical, pharmaceutical, or biotech industry.
- Strong background in regulated environments, including GMP, ISO9000, and regulatory affairs.
- Knowledge of systems and software applications.
- Proven ability to achieve goals through others.
- Familiarity with regulations including cGMPs, ISO, Import/Export, FDA requirements such as 21 CFR Part 11.
- Highly detail-oriented with strong analytical and problem-solving skills.
- Excellent communication skills, capable of communicating at all organizational levels.
- Ability to work collaboratively in a matrixed environment.
Qualifications:
- Bachelor's degree in Business, Project Management, Scientific, Engineering, or related field.
- At least 5 years of project management experience, preferably in Life Sciences focusing on quality and compliance.
- Experience managing multiple projects with timely, high-quality deliverables.
Knowledge, skills, and abilities:
- Excellent prioritization, organization, and project management skills.
- Strong analytical and problem-solving skills.
- Ability to handle multiple projects and deadlines with a results-driven approach.
- Strong interpersonal and leadership skills to foster teamwork and motivate personnel.
- Ability to obtain visibility and buy-in from senior leadership.
- Experience leading cross-functional teams without direct authority.
- Effective communication and collaboration skills across teams.
- Proficiency in Microsoft Outlook, Word, Excel, PowerPoint, Visio, Teams.
- Strong verbal and written communication skills.