GxP Quality & Compliance Manager- Life Sciences

SBM Management Services, LP; Raleigh (NC); On-site; USD 110,000 - 120,000; Full time

Job summary

SBM Management Services, LP 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 and client Quality representatives to ensure GMP adherence, strengthen quality systems, and drive sustainable improvements. Travel up to 50% is required.

Qualifications

• A.A. degree or equivalent with 2+ years of relevant experience.
• Experience in pharmaceutical/biotech or GxP regulated environments preferred.
• Strong communication and problem-solving skills.

Responsibilities

• Perform on-site assessments to verify program effectiveness and quality of service delivery.
• Lead CAPA processes and follow-up actions for at-risk programs.
• Investigate customer quality complaints and support root cause analysis.
• Conduct personnel compliance audits and maintain training schedules.
• Prepare routine reports for management and client interactions.
• Support new account transitions and client inspections (Regulatory, VIP).
• Assist with budget planning, cost estimates, and contracts.

Skills

GxP quality compliance

GMP knowledge

Quality systems

On-site assessments

CAPA process

Training delivery

Audit & investigations

Regulatory liaison

Project management

Education

A.A. Degree or higher

Tools

MS Office

Job description

Title:GxP Quality & Compliance Manager- Life SciencesJob Description:NOW HIRING: GxP Quality & Compliance ManagerCompensation: $110,000-$120,000 per yearTravel up to 50% requiredJob OverviewSBM 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 & ResponsibilitiesTo 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 deliveryMake recommendations, share best practices and implement actions to improve program SOW and/or quality service deliveryInvestigate customer complaints regarding quality and support RCA activitiesIdentify at risk programs and facilitate CAPA process and required follow up actions where neededMonitor internal processes for quality standards via on-site and remote program formal assessmentsSupport new account transitions as assignedGuide 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 servicePerform classroom style and on-the-job trainings (MGMT & Staff) to address and correct areas of concernComplete 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 improveSupport operations feed forward loop through proper execution of the CE Quality Events as assignedAudit inventory supplies and equipment for condition and SOW delivery effectivenessDevelop new approaches to solve problems identified during quality activitiesInvestigate and promote improved equipment and methodsImplement organization policies and goalsFacilitate budget requests, identify areas enhancements are necessary or reductions can be madeAssist with plans, budgets, and schedule modifications including cost estimates, bid sheets and contractsParticipate in the development of long-range plans for program/process improvementsSupport assigned sites in driving organic growth and new client opportunitiesCollect benchmarking data for preparing estimates, labor hours, expenses, and other metricsMaintain a safe work environment for self and employeesEnsure compliance with local, state, and federal regulations, such as, FLSA, OSHA, ADA, etc.Direct supervisory management engaged in support of controlled environment programsAct as liaison between company, customers, clients, employees, and subcontractorsAssist with human resource concerns and issuesSome travel is required for this positionQualificationTo 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 ExperienceA.A. Degree required with 2+ years of experience, or equivalent combination of education and experienceCertificates, 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 certificationMay be required to be forklift certifiedKnowledge, Skills, and AbilitiesBilingual a plusAbility to read and interpret instructions, procedures, manuals, and other documents Strong verbal and written communication skillsKnowledge of cleaning methods and equipment and willing to share with team Knowledge of the upkeep and care of the cleaning equipmentKnowledge of cleaning compounds and chemicals, and their safe, efficient useCustomer service, problem solving, time management, project management, planning, excellent communication, presentation, interviewing, coaching, and training skillsKnowledge of Microsoft Office and Computer SkillsAbility to respond to common inquiries or complaints from customers, regulatory agencies, or members of the business communityAbility to effectively present information and respond to questions from groups of managers, customers, employees, and general publicSupervisory ResponsibilitiesCarries out management responsibilities in accordance with the organization's policies and applicable laws. Responsibilities include interviewing, hiring, planning, assigning, and directing work; performance evaluations; rewarding and disciplining employees; addressing complaints and resolving problems. Ensure employees are properly trained on tasks and safety requirements.Physical Demands & Work EnvironmentThe physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is frequently required to sit and talk or listen. The employee must be able to lift and/or move up to 35 pounds.The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.Benefits:SBM offers comprehensive benefit packages. For information about SBM's benefits, please visit SBM's website at:www.sbmmanagement.com/careers Careers – SBMSBM Management Services, LP and its affiliates are proud to be equal opportunity workplaces. We are committed to equal employment opportunity regardless of race, sex, color, ancestry, religion, national origin, sexual orientation, citizenship, age, marital status, disability, gender identity, Veteran status, or other legally protected status.