GxP Quality & Compliance Manager
About the company
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.
Your tasks
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.
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
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
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.
Requirements
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.
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
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.
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
What we offer
Compensation: $110,000-$120,000 per year
SBM offers comprehensive benefit packages. For information about SBM's benefits, please visit SBM's website at:
Other
Title · GxP Quality & Compliance Manager Job Description NOW HIRING: GxP Quality & Compliance Manager CA & AZ
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.
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.