USWM, LLC
Manager, Validation & Data Integrity
USWM, LLC, Louisville, Kentucky, us, 40201
We are seeking an experienced and highly motivated Manager, Validation and Data Integrity, to join our team. The ideal candidate will have a robust background in cGMP pharmaceutical manufacturing and GxP biotechnology, with extensive experience in data integrity, quality assurance, validation, and regulatory compliance. You will set the strategy and oversee our approach to data integrity, data governance and computer systems validation, partnering with cross-functional teams across the business. You will work closely with cross-functional teams as a thought partner, and to ensure system compliance, advise on data processes, and provide audit support as needed.
Key Responsibilities:
Provide leadership and expertise in the interpretation, development, and implementation of global policies to ensure initial and on-going compliance of digital systems with cGMP, 21 CFR Part 11, Annex 11, and GAMP requirements.Collaborate with corporate functions to ensure continuous and verifiable compliance throughout the entire GMP digital environment and lifecycle.Support the overall readiness of the CSV program and computer-related systems to ensure software programs are compliant and ready for audits and regulatory inspections.Lead proposed GXP-related computer system change controls, investigations, CAPA, periodic reviews of GXP systems and system access in alignment with procedures to ensure compliance.Manage validation plans, protocols, reports and other verification/validation related documentation for GXP computer systems.Assess systems for data integrity and compliance with regulatory expectations including assessment of third-party IT service suppliers and applications.Participate in and support the external audit program for vendors related to GXP computerized systems.Provide QA guidance in the development and revision of GXP computer system procedures.Participate in cross-functional project teams in support of GXP computer system compliance.Work in collaboration with the system owners and administrators, to address priorities for programs and changes to GXP Computer system configuration, security, security profiles and any required migration plans for compliant implementation in alignment with organizational processes.Perform quality support duties including implementation, maintenance, and execution of quality management system processes.Provide ongoing Quality support, advice, and guidance to GXP related System Owners and System Administrators.Effectively manage priorities, multiple projects and ability to communicate with all levels of personnel.Qualifications:
Bachelor’s degree in engineering, science or equivalent technical discipline or a related field.At least 7+ years of experience in cGMP pharmaceutical manufacturing and GxP biotechnology.Extensive experience with computerized systems validation, quality assurance, and regulatory compliance.Proficiency in Quality Management Systems, Electronic Document Management Systems, and other relevant software.Skills:
Strong leadership and team management skills.Excellent communication and interpersonal skills.Ability to manage multiple projects and priorities simultaneously.In-depth knowledge of FDA regulations, EudraLex, MHRA, MHRB, MHLW, and ISO standards.Proficiency in Microsoft Office Suite, and other relevant software tools.The physical demands and work environment 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.
PHYSICAL DEMANDS:
Frequently required to standFrequently required to walk.Frequently required to sit.Frequently required to talk or hear.Occasionally required to lift light weights (less than 25 pounds)Specific vision abilities required for this job include: close vision, color vision and ability to adjust or focusAbility to travel, including overnight stays by plane, train or auto, up to 50%
US WorldMeds is an equal opportunity employer, and does not discriminate on the basis of race, color, religion, sex, pregnancy, national origin, disability age, genetic information, veteran status, sexual orientation, gender identity or any other characteristic protected by federal, state or local law.
Key Responsibilities:
Provide leadership and expertise in the interpretation, development, and implementation of global policies to ensure initial and on-going compliance of digital systems with cGMP, 21 CFR Part 11, Annex 11, and GAMP requirements.Collaborate with corporate functions to ensure continuous and verifiable compliance throughout the entire GMP digital environment and lifecycle.Support the overall readiness of the CSV program and computer-related systems to ensure software programs are compliant and ready for audits and regulatory inspections.Lead proposed GXP-related computer system change controls, investigations, CAPA, periodic reviews of GXP systems and system access in alignment with procedures to ensure compliance.Manage validation plans, protocols, reports and other verification/validation related documentation for GXP computer systems.Assess systems for data integrity and compliance with regulatory expectations including assessment of third-party IT service suppliers and applications.Participate in and support the external audit program for vendors related to GXP computerized systems.Provide QA guidance in the development and revision of GXP computer system procedures.Participate in cross-functional project teams in support of GXP computer system compliance.Work in collaboration with the system owners and administrators, to address priorities for programs and changes to GXP Computer system configuration, security, security profiles and any required migration plans for compliant implementation in alignment with organizational processes.Perform quality support duties including implementation, maintenance, and execution of quality management system processes.Provide ongoing Quality support, advice, and guidance to GXP related System Owners and System Administrators.Effectively manage priorities, multiple projects and ability to communicate with all levels of personnel.Qualifications:
Bachelor’s degree in engineering, science or equivalent technical discipline or a related field.At least 7+ years of experience in cGMP pharmaceutical manufacturing and GxP biotechnology.Extensive experience with computerized systems validation, quality assurance, and regulatory compliance.Proficiency in Quality Management Systems, Electronic Document Management Systems, and other relevant software.Skills:
Strong leadership and team management skills.Excellent communication and interpersonal skills.Ability to manage multiple projects and priorities simultaneously.In-depth knowledge of FDA regulations, EudraLex, MHRA, MHRB, MHLW, and ISO standards.Proficiency in Microsoft Office Suite, and other relevant software tools.The physical demands and work environment 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.
PHYSICAL DEMANDS:
Frequently required to standFrequently required to walk.Frequently required to sit.Frequently required to talk or hear.Occasionally required to lift light weights (less than 25 pounds)Specific vision abilities required for this job include: close vision, color vision and ability to adjust or focusAbility to travel, including overnight stays by plane, train or auto, up to 50%
US WorldMeds is an equal opportunity employer, and does not discriminate on the basis of race, color, religion, sex, pregnancy, national origin, disability age, genetic information, veteran status, sexual orientation, gender identity or any other characteristic protected by federal, state or local law.