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.
The ideal candidate brings practical experience in pharmaceutical, biotechnology, or other GxP regulated operations, along with the ability to translate quality requirements into effective daily practices.
Roles & Responsibilities
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. Other duties may be assigned.
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
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Other duties, responsibilities and activities may change or be assigned at any time with or without notice.
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…