GxP Quality & Compliance Manager- Life Sciences

SBM Management Services•Raleigh, NC

About The Position

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 works 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 has practical experience in pharmaceutical, biotechnology, or other GxP-regulated operations and can translate quality requirements into effective daily practices. Travel up to 50% is required. The role includes direct supervisory management supporting controlled-environment programs. The manager carries out supervisory responsibilities in accordance with organizational policies and applicable laws, including interviewing, hiring, assigning and directing work, evaluating performance, addressing employee complaints, resolving problems, and ensuring employees receive appropriate task and safety training.

Requirements

Associate degree and at least 2 years of experience, or an equivalent combination of education and experience.
Ability to read and interpret instructions, procedures, manuals, and other documents.
Strong verbal and written communication skills.
Knowledge of cleaning methods and equipment, and willingness to share that knowledge with the team.
Knowledge of the upkeep and care of cleaning equipment.
Knowledge of cleaning compounds and chemicals and their safe, efficient use.
Customer service, problem-solving, time-management, project-management, planning, 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 present information effectively and respond to questions from groups of managers, customers, employees, and the general public.
Ability to ensure employees are properly trained on tasks and safety requirements.
Ability to sit and talk or listen frequently and to lift and/or move up to 35 pounds.
A valid driver's license may be required based on business needs; employees who drive for work must maintain an acceptable MVR and meet company driving eligibility requirements.
Completion of all safety and task training certifications.

Nice To Haves

CPR/AED/First Aid certification.
Bilingual ability.
Forklift certification may be required.

Responsibilities

Conduct on-site assessments to determine program effectiveness in meeting contractual SOW requirements and quality-of-service expectations.
Recommend, share, and implement best practices and actions to improve program SOW performance and service quality.
Investigate customer quality complaints and support root-cause analysis activities.
Identify at-risk programs and facilitate CAPA processes and required follow-up actions.
Monitor internal processes against quality standards through formal on-site and remote program assessments.
Support new account transitions as assigned.
Guide and assist before and during high-level client service inspections, including regulatory, partner, and VIP inspections.
Conduct personnel compliance audits and develop or verify work schedules to ensure adequate service.
Deliver classroom and on-the-job training for management and staff to address and correct areas of concern.
Complete routine reporting and deliverables, keeping department and local management informed of significant issues and improvement actions.
Support the operations feed-forward loop through proper execution of assigned CE Quality Events.
Audit inventory, supplies, and equipment for condition and effectiveness in delivering the SOW.
Develop new approaches to solve problems identified through quality activities.
Investigate and promote improved equipment and methods.
Implement organizational policies and goals.
Facilitate budget requests and identify areas where enhancements or reductions may be appropriate.
Assist with plans, budgets, and schedule modifications, including cost estimates, bid sheets, and contracts.
Participate in developing long-range plans for program and process improvements.
Support assigned sites in driving organic growth and new client opportunities.
Collect benchmarking data for estimates, labor hours, expenses, and other metrics.
Maintain a safe work environment for self and employees.
Ensure compliance with applicable local, state, and federal regulations, including FLSA, OSHA, and ADA.
Direct supervisory management supporting controlled-environment programs.
Act as liaison among the company, customers, clients, employees, and subcontractors.
Assist with human resource concerns and issues.
Interview, hire, plan and assign work, direct employees, conduct performance evaluations, reward and discipline employees, address complaints, and resolve problems.