Kindeva Drug Delivery Company
Director, QA Validation
Kindeva Drug Delivery Company, California, Missouri, United States, 65018
Overview
Our Work Matters
At Kindeva we make products that save lives, ensuring better health and well-being for patients around the world.
The Impact You Will Make
We are seeking a seasoned Quality Assurance Validation Subject Matter Expert (SME) to lead the QA validation function at our sterile injectable GMP manufacturing site. The successful candidate will provide expert guidance and oversight for all aspects of equipment and utility qualification, process and cleaning validation, media fill activities, process validation, computer system validation, and data integrity compliance. This individual will play a key leadership role in ensuring that validation activities meet regulatory expectations, align with internal quality standards, and support efficient, compliant operations.
Responsibilities
Serve as the QA functional lead for validation, owning the quality oversight of validation programs for facilities, utilities, equipment, processes, cleaning, and computerized systems.
Review and approve validation master plans, protocols, reports, and risk assessments to ensure compliance with current GMP regulations, guidance documents, and internal procedures.
Provide QA oversight for media fill validations, ensuring proper design, execution, and documentation aligned with sterile product manufacturing requirements.
Lead the QA review and approval of cleaning validation strategies including campaign rationale, worst-case scenarios, acceptance criteria, and continued verification.
Provide QA guidance during qualification of equipment and utilities (URS, DQ, IQ, OQ, PQ), ensuring appropriate risk-based approach and adherence to applicable standards.
Oversee QA review and approval of computer system validation (CSV) deliverables in accordance with 21 CFR Part 11, EU Annex 11, and GAMP 5 principles.
Serve as QA approver and reviewer for periodic reviews and requalification strategies across validation lifecycle elements.
Champion data integrity across validation documentation, ensuring ALCOA+ principles are followed and integrated into all validation activities.
Collaborate with cross-functional teams (Engineering, Validation, Manufacturing, IT, QC) to support timely project execution while upholding QA expectations.
Act as the SME during internal and external inspections (FDA, EMA, customer audits), defending the site’s validation and QA oversight practices.
Identify and implement continuous improvement opportunities in the validation quality system and associated documentation lifecycle.
Mentor and train QA and validation staff on current validation expectations and regulatory updates.
Qualifications
Bachelor’s or advanced degree in life sciences, engineering, or a related field.
8+ years of experience in GMP pharmaceutical manufacturing, with strong experience in quality assurance oversight of validation programs.
Deep understanding of regulatory requirements (21 CFR Parts 210, 211, 11; EU GMP; Annex 1; ICH Q8–Q10; WHO, PIC/S) and industry best practices (GAMP 5).
Demonstrated expertise in sterile manufacturing validation, particularly aseptic process simulation (media fill), cleaning validation, and facility qualification.
Prior experience representing QA validation during regulatory inspections strongly preferred.
Kindeva does not accept unsolicited assistance from headhunters or recruitment firms for any of our job openings. Any resumes or candidate profiles submitted to Kindeva employees—regardless of format—without a valid, signed agreement and an approved job order from an authorized signatory in Talent Acquisition will be considered the sole property of Kindeva. No fees will be paid in the event that a candidate is hired as a result of an unsolicited resume or referral.
Equal Opportunity Employer:
Kindeva Drug Delivery is an Equal Opportunity/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, Protected Veteran status, sexual orientation, or any other characteristic protected by federal, state or local law.
Do you see yourself as part of the Kindeva mission? Click Apply Now Today!
#J-18808-Ljbffr
At Kindeva we make products that save lives, ensuring better health and well-being for patients around the world.
The Impact You Will Make
We are seeking a seasoned Quality Assurance Validation Subject Matter Expert (SME) to lead the QA validation function at our sterile injectable GMP manufacturing site. The successful candidate will provide expert guidance and oversight for all aspects of equipment and utility qualification, process and cleaning validation, media fill activities, process validation, computer system validation, and data integrity compliance. This individual will play a key leadership role in ensuring that validation activities meet regulatory expectations, align with internal quality standards, and support efficient, compliant operations.
Responsibilities
Serve as the QA functional lead for validation, owning the quality oversight of validation programs for facilities, utilities, equipment, processes, cleaning, and computerized systems.
Review and approve validation master plans, protocols, reports, and risk assessments to ensure compliance with current GMP regulations, guidance documents, and internal procedures.
Provide QA oversight for media fill validations, ensuring proper design, execution, and documentation aligned with sterile product manufacturing requirements.
Lead the QA review and approval of cleaning validation strategies including campaign rationale, worst-case scenarios, acceptance criteria, and continued verification.
Provide QA guidance during qualification of equipment and utilities (URS, DQ, IQ, OQ, PQ), ensuring appropriate risk-based approach and adherence to applicable standards.
Oversee QA review and approval of computer system validation (CSV) deliverables in accordance with 21 CFR Part 11, EU Annex 11, and GAMP 5 principles.
Serve as QA approver and reviewer for periodic reviews and requalification strategies across validation lifecycle elements.
Champion data integrity across validation documentation, ensuring ALCOA+ principles are followed and integrated into all validation activities.
Collaborate with cross-functional teams (Engineering, Validation, Manufacturing, IT, QC) to support timely project execution while upholding QA expectations.
Act as the SME during internal and external inspections (FDA, EMA, customer audits), defending the site’s validation and QA oversight practices.
Identify and implement continuous improvement opportunities in the validation quality system and associated documentation lifecycle.
Mentor and train QA and validation staff on current validation expectations and regulatory updates.
Qualifications
Bachelor’s or advanced degree in life sciences, engineering, or a related field.
8+ years of experience in GMP pharmaceutical manufacturing, with strong experience in quality assurance oversight of validation programs.
Deep understanding of regulatory requirements (21 CFR Parts 210, 211, 11; EU GMP; Annex 1; ICH Q8–Q10; WHO, PIC/S) and industry best practices (GAMP 5).
Demonstrated expertise in sterile manufacturing validation, particularly aseptic process simulation (media fill), cleaning validation, and facility qualification.
Prior experience representing QA validation during regulatory inspections strongly preferred.
Kindeva does not accept unsolicited assistance from headhunters or recruitment firms for any of our job openings. Any resumes or candidate profiles submitted to Kindeva employees—regardless of format—without a valid, signed agreement and an approved job order from an authorized signatory in Talent Acquisition will be considered the sole property of Kindeva. No fees will be paid in the event that a candidate is hired as a result of an unsolicited resume or referral.
Equal Opportunity Employer:
Kindeva Drug Delivery is an Equal Opportunity/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, Protected Veteran status, sexual orientation, or any other characteristic protected by federal, state or local law.
Do you see yourself as part of the Kindeva mission? Click Apply Now Today!
#J-18808-Ljbffr