Kavis Pharma LLC
POSITION IS ON-SITE NEAR HOUSTON, TEXAS
POSITION PURPOSE
A brief summary of the purpose this position must fulfill
.
Oversee and manage the site's Quality Management System (QMS) and Quality Assurance Operations to ensure compliance with global cGMP requirements, Kavis Pharma policies, and applicable regulations. This role provides quality oversight of manufacturing, packaging, sampling, and release activities while driving development, maintenance, and continuous improvement of quality systems, training programs, and vendor qualification. Serving as a subject-matter expert, the Senior Manager partners with cross-functional teams to safeguard data integrity, ensure operational readiness, and maintain a state of control. The position also develops and mentors quality staff, supports inspection readiness, and fosters a culture of compliance and continuous improvement.
Perform job functions in accordance with all applicable Standard Operating Procedures (SOP), federal and state laws, Occupational Safety and Health Administration (OSHA) guidelines, health authority regulations, and departmental processes.
ESSENTIAL DUTIES AND RESPONSIBILITIES
To perform this job successfully, an individual must satisfactorily perform each essential duty. Reasonable accommodations may be made
to
enable individuals with disabilities to perform the essential duties.
Serve as subject-matter expert during regulatory and customer inspections; prepare for, host, and manage inspection responses. Provide site leadership for the Quality Management System (QMS), including eQMS (TrackWise), SAP, and other integrated quality platforms; maintain validated state and ensure data integrity. Oversee initiation, investigation, approval, and closure of deviations, CAPAs, internal audits, and change controls in compliance with cGMP requirements. Maintain robust document-control procedures, including issuance, revision, and archival of GMP documentation. Manage quality oversight of manufacturing, packaging, sampling, and materials release activities to ensure accuracy, lot integrity, and compliance. Lead the vendor-qualification and supplier management program, including assessments, approvals, and periodic reviews. Oversee the site-wide GxP training system, ensuring curricula align with regulatory requirements and remain inspection-ready. Collaborate cross-functionally with Manufacturing, Validation, Supply Chain, and other departments to resolve quality issues and support production schedules. Generate, interpret, and report site quality metrics; recommend and implement continuous improvement and operational excellence initiatives. Prepare, review, and enforce SOPs, ensuring compliance with global regulatory requirements and industry standards. Develop, coach, and evaluate Quality staff, fostering a culture of accountability, compliance, and continuous learning. Stay current with regulatory expectations and industry best practices; lead implementation of system and process enhancements. Serve as the primary Quality liaison for customer interactions and communications.
QUALIFICATIONS
The qualifications listed below are representative of the minimum knowledge, skill and /or ability required.
KNOWLEDGE
In-depth knowledge of FDA, EU, and ICH quality regulations, including 21 CFR Parts 210/211, Part 11, and data integrity requirements. Strong working knowledge of cGMP, quality systems, validation processes, and applicable pharmacopeial standards (USP, EP). Hands-on experience with eQMS (TrackWise or equivalent), SAP, and other integrated quality/enterprise systems. Familiarity with vendor qualification, training systems, and operational excellence methodologies.
SKILLS AND ABILITIES
Strong leadership, interpersonal, and communication skills, with the ability to work effectively across functions and levels. Skilled in problem solving, root cause analysis, and driving investigations/CAPA through closure. Ability to generate, interpret, and present quality metrics to support decision-making. Proficient with MS Office tools (Word, Excel, PowerPoint, Access) and electronic quality/compliance platforms. Strong organizational, multitasking, and consensus-building skills with a high degree of accountability.
SUPERVISION
Position functions autonomously. Position directly supervises employees. Carry out management responsibilities in accordance with the organization's policies and applicable laws. Responsibilities include interviewing, hiring and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.
EDUCATION/EXPERIENCE
Bachelor's degree in a scientific or technical discipline (or equivalent). Master's degree preferred. 5-8+ years of progressive experience in pharmaceutical Quality Assurance and/or Quality Systems, including validation, quality engineering, or operations oversight. Minimum of 5 years management experience leading quality professionals.
LICENSES/CERTIFICATIONS
None. However, professional certifications (e.g., Certified Quality Auditor/Manager, Six Sigma Green/Black Belt, or equivalent) preferred.
LANGUAGE SKILLS
Excellent written, verbal, and audit-facing communication skills. Ability to work with executives and communicate abstract concepts. Ability to present to a high level of the organization and groups outside of the organization.
MATHEMATICAL SKILLS
Ability to solve equations, apply technical mathematical concepts, and perform complex computations.
REASONING ABILITY
Ability to read and interpret technical and scientific documents and prepare clear reports and correspondence. Ability to exercise independent judgment, solve complex problems, and manage competing priorities.
PHYSICAL DEMANDS
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential duties of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform essential duties.
Typically sitting at a desk. Intermittently sitting, standing, walking or stooping. Requires periodic travel. May be required to stand; walk; stoop; bend; kneel; and climb steps. May require use of hands and use of arms. Light lifting requirements.
WORK ENVIRONMENT
The work environment characteristics described here are representative of those an employee encounters while performing the essential duties of this job.
Reasonable accommodations may be made to enable individuals with disabilities to perform essential duties.
Office and pharmaceutical manufacturing environment.
POSITION PURPOSE
A brief summary of the purpose this position must fulfill
.
Oversee and manage the site's Quality Management System (QMS) and Quality Assurance Operations to ensure compliance with global cGMP requirements, Kavis Pharma policies, and applicable regulations. This role provides quality oversight of manufacturing, packaging, sampling, and release activities while driving development, maintenance, and continuous improvement of quality systems, training programs, and vendor qualification. Serving as a subject-matter expert, the Senior Manager partners with cross-functional teams to safeguard data integrity, ensure operational readiness, and maintain a state of control. The position also develops and mentors quality staff, supports inspection readiness, and fosters a culture of compliance and continuous improvement.
Perform job functions in accordance with all applicable Standard Operating Procedures (SOP), federal and state laws, Occupational Safety and Health Administration (OSHA) guidelines, health authority regulations, and departmental processes.
ESSENTIAL DUTIES AND RESPONSIBILITIES
To perform this job successfully, an individual must satisfactorily perform each essential duty. Reasonable accommodations may be made
to
enable individuals with disabilities to perform the essential duties.
Serve as subject-matter expert during regulatory and customer inspections; prepare for, host, and manage inspection responses. Provide site leadership for the Quality Management System (QMS), including eQMS (TrackWise), SAP, and other integrated quality platforms; maintain validated state and ensure data integrity. Oversee initiation, investigation, approval, and closure of deviations, CAPAs, internal audits, and change controls in compliance with cGMP requirements. Maintain robust document-control procedures, including issuance, revision, and archival of GMP documentation. Manage quality oversight of manufacturing, packaging, sampling, and materials release activities to ensure accuracy, lot integrity, and compliance. Lead the vendor-qualification and supplier management program, including assessments, approvals, and periodic reviews. Oversee the site-wide GxP training system, ensuring curricula align with regulatory requirements and remain inspection-ready. Collaborate cross-functionally with Manufacturing, Validation, Supply Chain, and other departments to resolve quality issues and support production schedules. Generate, interpret, and report site quality metrics; recommend and implement continuous improvement and operational excellence initiatives. Prepare, review, and enforce SOPs, ensuring compliance with global regulatory requirements and industry standards. Develop, coach, and evaluate Quality staff, fostering a culture of accountability, compliance, and continuous learning. Stay current with regulatory expectations and industry best practices; lead implementation of system and process enhancements. Serve as the primary Quality liaison for customer interactions and communications.
QUALIFICATIONS
The qualifications listed below are representative of the minimum knowledge, skill and /or ability required.
KNOWLEDGE
In-depth knowledge of FDA, EU, and ICH quality regulations, including 21 CFR Parts 210/211, Part 11, and data integrity requirements. Strong working knowledge of cGMP, quality systems, validation processes, and applicable pharmacopeial standards (USP, EP). Hands-on experience with eQMS (TrackWise or equivalent), SAP, and other integrated quality/enterprise systems. Familiarity with vendor qualification, training systems, and operational excellence methodologies.
SKILLS AND ABILITIES
Strong leadership, interpersonal, and communication skills, with the ability to work effectively across functions and levels. Skilled in problem solving, root cause analysis, and driving investigations/CAPA through closure. Ability to generate, interpret, and present quality metrics to support decision-making. Proficient with MS Office tools (Word, Excel, PowerPoint, Access) and electronic quality/compliance platforms. Strong organizational, multitasking, and consensus-building skills with a high degree of accountability.
SUPERVISION
Position functions autonomously. Position directly supervises employees. Carry out management responsibilities in accordance with the organization's policies and applicable laws. Responsibilities include interviewing, hiring and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.
EDUCATION/EXPERIENCE
Bachelor's degree in a scientific or technical discipline (or equivalent). Master's degree preferred. 5-8+ years of progressive experience in pharmaceutical Quality Assurance and/or Quality Systems, including validation, quality engineering, or operations oversight. Minimum of 5 years management experience leading quality professionals.
LICENSES/CERTIFICATIONS
None. However, professional certifications (e.g., Certified Quality Auditor/Manager, Six Sigma Green/Black Belt, or equivalent) preferred.
LANGUAGE SKILLS
Excellent written, verbal, and audit-facing communication skills. Ability to work with executives and communicate abstract concepts. Ability to present to a high level of the organization and groups outside of the organization.
MATHEMATICAL SKILLS
Ability to solve equations, apply technical mathematical concepts, and perform complex computations.
REASONING ABILITY
Ability to read and interpret technical and scientific documents and prepare clear reports and correspondence. Ability to exercise independent judgment, solve complex problems, and manage competing priorities.
PHYSICAL DEMANDS
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential duties of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform essential duties.
Typically sitting at a desk. Intermittently sitting, standing, walking or stooping. Requires periodic travel. May be required to stand; walk; stoop; bend; kneel; and climb steps. May require use of hands and use of arms. Light lifting requirements.
WORK ENVIRONMENT
The work environment characteristics described here are representative of those an employee encounters while performing the essential duties of this job.
Reasonable accommodations may be made to enable individuals with disabilities to perform essential duties.
Office and pharmaceutical manufacturing environment.