Quality Assurance Manager
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GxP Quality & Compliance Manager
Job Description
NOW HIRING: GxP Quality & Compliance Manager CA & AZCompensation: $110,000-$120,000 per yearTravel 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.
Education and/ or Experience
A.
A. Degree required with 2+ years of experience, or equivalent combination of education and experience
Certificates, Licenses, RegistrationsCPR/AED/First Aid certification a plusA 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 to questions from groups of managers, customers, employees, and general public
Supervisory Responsibilities
Carries out management responsibilities in accordance with the organization's p