cGMP Specialist - Project Management

Houston Methodist

Houston (TX)

On-site

USD 85,000 - 110,000

Full time

14 days+

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Job summary

Houston Methodist seeks a cGMP Specialist Project Specialist to drive manufacturing projects within the Office of Translational Production and Quality. You will liaison between clients and internal operations, develop plans, track resources, manage budgets, and organize regular update meetings for project teams to ensure milestones are met.

The role emphasizes SOP/cGMP adherence, review of procedures, equipment validation, and inspections support, with collaboration across QA, process

Qualifications

Bachelor’s degree in a relevant field; Master’s degree preferred.
Minimum three years of experience in biotech/pharma with cGMP exposure.
Experience performing IQ/OQ/PQ, audits and inspections preferred.
Familiarity with FDA regulations and GLP/cGMP concepts.
Proficiency with MS Office and presentation software.

Responsibilities

Develop and manage project plans, track milestones and deliverables.
Coordinate cross-functional teams to meet quality and compliance goals.
Assist in audits, regulatory inspections and deviation investigations.
Serve as liaison between clients and internal operations to ensure clarity.

Skills

Clear communication

Regulatory awareness

Project coordination

Cross-functional collaboration

Attention to detail

Prioritization under pressure

Education

Bachelor’s degree

Master’s degree preferred

Job description

The cGMP Specialist Project Specialist drives the successful execution of manufacturing projects within the Office of Translational Production and Quality, serving as the primary liaison between our clients and internal operations. This role encompasses a variety of responsibilities, including developing project plans, tracking and reporting on project resources, deliverables, and milestones, managing budgets, and organizing regular update meetings for project teams. By providing project management oversight, this role contributes to the achievement of strategic goals through strategic input, cross-functional collaboration, and clear visibility on project progress.

At Houston Methodist, the Current Good Manufacturing Practice (cGMP) Specialist position is responsible for adherence to Standard Operating Procedures (SOPs) and cGMP regulations pertaining to the manufacture of therapeutics and devices. Additionally, this position will be responsible for assisting senior team members with aspects of compliance associated with the quality operations including but not limited to; review of procedures, verification of equipment and facility cleanliness, proper gowning, correct material labelling, correct operating parameters for equipment and proper execution of protocols in accordance with approved SOPs.

FLSA STATUS

Exempt

QUALIFICATIONS

EDUCATION

Bachelor’s degree
Master’s degree preferred

EXPERIENCE

Three years of experience in the biotechnology or pharmaceutical industry with exposure to cGMP manufacturing operations
Experience performing equipment validation (IQ/OQ/PQ), facility commissioning, internal/ external audits, batch record review and hosting regulatory inspections preferred

SKILLS AND ABILITIES

Demonstrates the skills and competencies necessary to safely perform the assigned job, determined through on-going skills, competency assessments, and performance evaluations
Sufficient proficiency in speaking, reading, and writing the English language necessary to perform the essential functions of this job, especially with regard to activities impacting patient or employee safety or security
Ability to effectively communicate with patients, physicians, family members and co-workers in a manner consistent with a customer service focus and application of positive language principles
Familiar with quality, compliance and FDA regulatory requirements for Good Laboratory Practice (GLP) and cGMP auditing procedures
Proficiency in spreadsheet, word processing and presentation software
Ability to work under pressure and balance many competing priorities; highly responsive and solution/action oriented
Ability to mentor and coach department personnel
Knowledge of regulations applicable to drugs and devices (21 CFR Parts 210/211, Medical Device Regulations, ICH and FDA guidances, etc.) and the ability to apply them based on the phase of the project (GLP, Phase I, PhaseII/III etc.)

ESSENTIAL FUNCTIONS

PEOPLE ESSENTIAL FUNCTIONS

Collaborates with cross functional teams including research, process development, quality assurance and quality control.
Works with research team members to assist them with transitioning their research processes to compliant cGMP SOPs.
Participates in multi-functional project teams, as necessary.

SERVICE ESSENTIAL FUNCTIONS

Participates in internal audits and external inspections by Regulatory Agencies.
Responds to calls/alarms off hours and weekends for facility systems and equipment failures.

QUALITY/SAFETY ESSENTIAL FUNCTIONS

Ensures development, pre-clinical and clinical product supply are executed effectively against changing demand schedule and meet quality requirements.
Assists in internal inspections and audits to ensure compliance with Federal Drug Administration (FDA) regulations and cGMP Core policies and procedures.
Assists with discrepancy inspections.

FINANCE ESSENTIAL FUNCTIONS

Uses resources efficiently; does not waste supplies. Self-motivated to independently manage time effectively and prioritize daily tasks.

GROWTH/INNOVATION ESSENTIAL FUNCTIONS

Assists Quality Assurance Manager, cGMP Core Director and/or team members in defining release testing requirements, developing and executing protocols, performing periodic updates and/or revisions to SOPs.
Seeks opportunities to expand learning beyond baseline competencies with a focus on continual development.

SUPPLEMENTAL REQUIREMENTS

WORK ATTIRE