Project Manager, GMP

3 days ago

Mission Viejo, United States BENEV Company Inc Full time

About The Role

Project Manager at BENEV plays a critical role in managing projects related to the growth and 

development of GMP facilities and systems. This role requires strong leadership, organizational, 

and communication skills to ensure projects are completed on time, within scope, and on budget. 

The Project Manager will work closely with cross-functional teams, stakeholders, and external 

partners, primarily collaborating with BENEV’s Facilities, Manufacturing, Supply Operations, and 

Quality Validation Teams. The ideal candidate will have experience managing projects in GMP 

environment with a focus on equipment validation, facility release, and quality change controls.


What You’ll Do

• Develop and maintain comprehensive project plans, including scope, timelines, resources, 

and budgets.

• Lead project teams to meet quality and compliance standards, ensuring timely execution.

• Build and maintain strong relationships with internal and external stakeholders, ensuring 

clear communication, alignment on project goals, and effective issue resolution.

• Manage project resources, including personnel, budget, and technology, to support project 

success.

• Ensure adherence to quality standards, best practices, and compliance.

• Maintain project documentation, including status reports, project charters, and other 

relevant documents, and provide regular updates to senior leadership and stakeholders.

• Implement change management strategies and communicate project changes as needed.

• Coordinate with engineering, facilities, and quality teams to ensure the timely installation, 

commissioning, and qualification of equipment and systems.

• Oversee the validation process for critical systems, including HVAC, water systems, and 

production equipment to ensure all systems are compliant with GMP regulations and 

company SOP’s.

• Work closely with internal stakeholders, including Quality Assurance, Manufacturing, and 

Engineering teams, to ensure seamless project execution and compliance with GMP 

standards.

• Identify potential risks associated with GMP facilities and systems projects and develop 

mitigation strategies to address these risks proactively.

• Maintain detailed project documentation, including validation protocols, change controls, 

and status reports, ensuring all documentation meets regulatory and company 

requirements.

• Drive continuous improvement initiatives related to GMP facilities and systems, identifying 

opportunities for process optimization.

• Serve as the primary point of contact for all GMP facility and systems projects, providing 

regular updates to senior management and other stakeholders.


What You’ll Bring

• 5+ years of project management experience within a GMP-regulated environment.

• Strong knowledge of GMP regulations, particularly in facility and system validation.

• Experience partnering with quality systems teams/function.

• Proven experience managing complex, cross-functional projects.

• Excellent communication, organizational, and problem-solving skills.

• Ability to work independently and manage multiple priorities in a fast-paced environment.


Preferred Skills

• Knowledge of regulatory requirements for system validation (e.g., FDA, EMA).

• Familiarity with Lean Six Sigma or other process improvement methodologies.

• Project Management Certifications (e.g., PMP).


Work Environment and Physical Demands

This position works in a typical office environment where the physical work demands will vary 

depending on the specific tasks and duties required of the job. This is largely a sedentary role; 

persons holding office positions are generally subject to inside environmental conditions having the 

lighting, temperature, and noise of an open floor-plan office environment. Regularly operate a 

computer and other office equipment. Regularly communicate with others in person, over the 

phone, and electronically. Must be able to move and/or carry objects weighing up to 10 lbs.

This job description is not designed to cover or contain a comprehensive listing of activities, duties 

or responsibilities that are required of the employee. Duties, responsibilities and activities may 

change or new ones may be assigned.


BENEV is an equal opportunity employer dedicated to building an inclusive and diverse workforce. 

BENEV, provides equal employment opportunities to all employees and applicants for employment 

and prohibits discrimination and harassment of any type without regard to race, color, religion, age, 

sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender 

identity or expression, or any other characteristic protected by federal, state or local laws.

HARDWORKING - We work hard and smart, making a persistent and determined effort toward 

success. Working hard, with focus and desire is the key.


OPEN - We strive to be approachable, actively listen and encourage others to contribute and speak 

up. We positively offer and receive constructive feedback.

PURPOSE DRIVEN - We are passionate about working towards and delivering on our mission to 

manufacture gene therapies.

ENGAGED - We are fully absorbed by and enthusiastic about our work and take positive action to 

further Forge’s vision, mission and goals.

• Health, Dental, and Vision insurance 

• Flexible PTO 

• 401(K) company match

• Employee Assistance Program

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