GxP Quality & Compliance Manager- Life Sciences

Pacific West Site Services, Inc.; Raleigh (NC); On-site; USD 110,000 - 120,000; Full time

Job summary

Pacific West Site Services, Inc. is seeking a hands-on GxP Quality & Compliance Manager to support the execution, compliance, and continuous improvement of Critical Environments services across regulated life sciences client sites.

This field-based role collaborates with site operations, cleaning teams, and client Quality representatives to ensure GMP adherence and drive improvements. The role requires up to 50% travel, a strong quality systems background, and the ability to lead CAPA processes,

Qualifications

• A.A. Degree required with 2+ years of experience, or equivalent combination of education and experience
• CPR/AED/First Aid certification a plus
• A valid driver's license may be required for this position based on business needs. Employees required to drive as part of their job duties must maintain an acceptable Motor Vehicle Record (MVR) and meet company driving eligibility requirements.
• Completed all safety and task training certification
• Forklift certification may be required

Responsibilities

• Perform on-site assessments determining effectiveness of program in meeting contractual SOW and quality of service delivery
• Make recommendations, share best practices and implement actions to improve program SOW and/or quality service delivery
• Investigate customer complaints regarding quality and support RCA activities
• Identify at risk programs and facilitate CAPA process and required follow up actions where needed
• Monitor internal processes for quality standards via on-site and remote program formal assessments
• Support new account transitions as assigned
• Guide and assist prior to and during high level client service inspections (i.e. Regulatory, Partner, VIP)
• Conduct personnel compliance audits, develop and/or verify work schedules to ensure adequate service
• Perform classroom style and on-the-job trainings (MGMT & Staff) to address and correct areas of concern
• Complete routine reporting and deliverables associated with the position keeping Dept. and local management team informed of significant issues identified during activities and actions taken to improve
• Support operations feed forward loop through proper execution of the CE Quality Events as assigned
• Audit inventory supplies and equipment for condition and SOW delivery effectiveness
• Develop new approaches to solve problems identified during quality activities
• Investigate and promote improved equipment and methods
• Implement organization policies and goals
• Facilitate budget requests, identify areas enhancements are necessary or reductions can be made
• Assist with plans, budgets, and schedule modifications including cost estimates, bid sheets and contracts
• Participate in the development of long-range plans for program/process improvements
• Support assigned sites in driving organic growth and new client opportunities
• Collect benchmarking data for preparing estimates, labor hours, expenses, and other metrics
• Maintain a safe work environment for self and employees
• Ensure compliance with local, state, and federal regulations, such as, FLSA, OSHA, ADA, etc.
• Direct supervisory management engaged in support of controlled environment programs
• Act as liaison between company, customers, clients, employees, and subcontractors
• Assist with human resource concerns and issues
• Some travel is required for this position

Skills

Verbal communication

Written communication

Project management

Training skills

Customer service

Time management

Presentation skills

Interviewing

Education

A.A. Degree with 2+ years experience

Tools

Microsoft Office

Job description

Title: GxP Quality & Compliance Manager- Life Sciences

Job Description:

NOW HIRING: GxP Quality & Compliance Manager

Compensation: $110,000-$120,000 per year

Travel up to 50% required

Job Overview

SBM is seeking a hands-on GxP Quality & Compliance Manager to support the execution, compliance, and continuous improvement of Critical Environments services across regulated life sciences client sites.

This field-based role will work closely with site operations, frontline cleaning teams, and client Quality representatives to assess program effectiveness, ensure adherence to GMP requirements, strengthen quality systems, and drive sustainable improvements.

Roles & Responsibilities

• Perform on-site assessments determining effectiveness of program in meeting contractual SOW and quality of service delivery
• Make recommendations, share best practices and implement actions to improve program SOW and/or quality service delivery
• Investigate customer complaints regarding quality and support RCA activities
• Identify at risk programs and facilitate CAPA process and required follow up actions where needed
• Monitor internal processes for quality standards via on-site and remote program formal assessments
• Support new account transitions as assigned
• Guide and assist prior to and during high level client service inspections (i.e. Regulatory, Partner, VIP)
• Conduct personnel compliance audits, develop and/or verify work schedules to ensure adequate service
• Perform classroom style and on-the-job trainings (MGMT & Staff) to address and correct areas of concern
• Complete routine reporting and deliverables associated with the position keeping Dept. and local management team informed of significant issues identified during activities and actions taken to improve
• Support operations feed forward loop through proper execution of the CE Quality Events as assigned
• Audit inventory supplies and equipment for condition and SOW delivery effectiveness
• Develop new approaches to solve problems identified during quality activities
• Investigate and promote improved equipment and methods
• Implement organization policies and goals
• Facilitate budget requests, identify areas enhancements are necessary or reductions can be made
• Assist with plans, budgets, and schedule modifications including cost estimates, bid sheets and contracts
• Participate in the development of long-range plans for program/process improvements
• Support assigned sites in driving organic growth and new client opportunities
• Collect benchmarking data for preparing estimates, labor hours, expenses, and other metrics
• Maintain a safe work environment for self and employees
• Ensure compliance with local, state, and federal regulations, such as, FLSA, OSHA, ADA, etc.
• Direct supervisory management engaged in support of controlled environment programs
• Act as liaison between company, customers, clients, employees, and subcontractors
• Assist with human resource concerns and issues
• Some travel is required for this position

Qualification

Education and/ or Experience

• A.A. Degree required with 2+ years of experience, or equivalent combination of education and experience

Certificates, Licenses, Registrations

• CPR/AED/First Aid certification a plus
• A valid driver's license may be required for this position based on business needs. Employees required to drive as part of their job duties must maintain an acceptable Motor Vehicle Record (MVR) and meet company driving eligibility requirements.
• Completed all safety and task training certification
• May be required to be forklift certified

Knowledge, Skills, and Abilities

• Bilingual a plus
• Ability to read and interpret instructions, procedures, manuals, and other documents
• Strong verbal and written communication skills
• Knowledge of cleaning methods and equipment and willing to share with team
• Knowledge of the upkeep and care of the cleaning equipment
• Knowledge of cleaning compounds and chemicals, and their safe, efficient use
• Customer service, problem solving, time management, project management, planning, excellent communication, presentation, interviewing, coaching, and training skills
• Knowledge of Microsoft Office and Computer Skills
• Ability to respond to common inquiries or complaints from customers, regulatory agencies, or members of the business community
• Ability to effectively present information and respond t