Compliance Specialist Visa Sponsorship Jobs in Indiana

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 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 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

SBM 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.