GxP Quality & Compliance Manager- Life Sciences

SBM Offshore

Springfield (IL)

Presencial

USD 110.000 - 120.000

Jornada completa

Hace 10 días

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Descripción de la vacante

SBM Offshore seeks a hands-on GxP Quality & Compliance Manager for Life Sciences to drive QA activities across regulated client sites. The role focuses on GMP adherence, quality system improvements, and translating requirements into actionable daily practices.

The ideal candidate has life sciences GxP experience and can work closely with operations, cleaning teams, and client Quality reps to ensure program effectiveness and continuous improvement.

Formación

  • A.A. degree required with 2+ years of related experience.
  • GxP/quality control experience in life sciences or regulated environments.
  • Willingness to travel up to 50%.
  • Strong communication and audit skills.
  • Ability to interpret regulatory requirements (GMP/GLP) and apply on-site.

Responsabilidades

  • Perform on-site assessments to determine program effectiveness against SOW and quality of service.
  • Recommend improvements and share best practices to enhance SOW and service quality.
  • Investigate customer quality complaints and support root-cause analyses.
  • Identify at-risk programs and facilitate CAPA processes and follow-up actions.
  • Monitor internal processes for quality standards via on-site and remote assessments.
  • Support new account transitions as assigned.
  • Assist with client inspections (Regulatory, Partner, VIP).
  • Conduct personnel compliance audits and schedule-based work planning.
  • Provide trainings to address and correct quality concerns.
  • Prepare routine reports keeping management informed of issues and actions.

Conocimientos

GxP Knowledge
Regulatory Compliance
Quality Assurance
Cross-functional Collaboration
Field Operations

Educación

A.A. degree

Descripción del empleo

Title:

GxP Quality & Compliance Manager- Life Sciences

Job Description:

NOW HIRING: GxP Quality & Compliance ManagerCompensation: $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
  • 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 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 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 public

Supervisory Responsibilities

Carries 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 Environment

The 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.

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