GMP Project Implementation Manager

The Planet Group; Paris (KY); On-site; USD 80,000 - 100,000; Full time

Job summary

A leading company in the life sciences sector is seeking a GMP Project Implementation Manager in Paris, KY. This role requires a seasoned professional with extensive experience in project management within regulated environments. Responsibilities include overseeing diverse projects, ensuring compliance with GMP regulations, and leading cross-functional teams to achieve project milestones. Ideal candidates will bring strong analytical skills, attention to detail, and a proven track record in delivering high-quality outcomes.

Qualifications

• 5+ years in project management in regulated industries.
• Deep knowledge of GMP regulations and compliance.
• Experience with ISO standards and FDA requirements.

Responsibilities

• Oversee project lifecycle, ensuring compliance and quality standards.
• Collaborate with teams to define project scopes and objectives.
• Monitor project performance and communication with senior management.

Skills

Project Management

Quality Assurance

Regulatory Affairs

Analytical Skills

Problem Solving

Communication

Education

Formal Project Management Training

PMP Certification

Tools

Project Management Software

Job description

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Position Summary

Our client is seeking a highly experienced GMP Project Implementation Manager to oversee a portfolio of quality-focused projects in a regulated industry setting. This role requires deep expertise in project and program management within life sciences, pharmaceuticals, chemicals, or biotechnology sectors. The Project Implementation Manager will collaborate across cross-functional teams to ensure projects are delivered on time, within scope and budget, and in compliance with all relevant regulatory standards.

Top Required Experience

• Minimum 5 years of experience in a project management role, preferably within the life sciences sector, with a strong emphasis on quality and compliance in regulated industries.
• At least 5 years of experience in a regulated environment or related role within chemical, pharmaceutical, or biotechnology industries.
• Proven background in compliance with GMP regulations, ISO standards (such as ISO 9000), and/or regulatory affairs.
• Experience managing end-to-end project life cycles; formal project management training required; certification (e.g., PMP) is a plus.
• Demonstrated working knowledge of applicable regulations including cGMPs, ISO, Import/Export, and FDA requirements such as 21 CFR Parts 210/211 and Part 11.

Key Responsibilities

• Collaborate with internal and external stakeholders to define project scopes, objectives, and deliverables.
• Develop detailed project plans, track milestones, and ensure successful execution and delivery.
• Monitor performance using appropriate tools and systems; maintain accurate project tracking within product development software.
• Communicate project challenges, risks, or delays to senior management and escalate issues appropriately.
• Organize and lead team meetings to evaluate progress, adjust plans, and keep deliverables aligned with timelines.
• Identify, assess, and mitigate project risks to ensure smooth execution.
• Facilitate all phases of project implementation including preparation, documentation, and delivery of project milestones and events.
• Support teams in readiness assessments for tollgate/milestone reviews and actively participate or lead those sessions.
• Drive root cause analysis and implement corrective actions to resolve any issues impacting scope, quality, timing, or budget.
• Perform additional duties as assigned.

Required Knowledge and Skills

• Proven ability to manage complex projects through to successful completion.
• Background in Quality Assurance, Regulatory Affairs, or IT systems related to quality and compliance.
• Solid understanding of systems and software tools used for project management and regulatory tracking.
• Familiarity with regulatory standards including cGMP, ISO, FDA regulations (21 CFR Parts 210/211, Part 11), and international compliance requirements.
• Highly detail-oriented with excellent analytical, problem-solving, and organizational skills.
• Strong written and verbal communication skills; ability to effectively engage stakeholders across all levels of the organization.
• Comfortable working in a matrixed environment and collaborating with cross-functional teams.

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Contract

Job function

• Job function

  Project Management

• Industries

  Technology, Information and Media

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