QA Validation Manager at AbbVie

About AbbVie

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology, and neuroscience, as well as products and services in our Allergan Aesthetics portfolio.

About the Role

This position serves as a central pillar for Quality oversight and approval regarding qualification and validation, ensuring full compliance with regulatory regulations and guidelines. You will administer and control the Validation program, covering equipment, processes, utilities, facilities, computers, cleaning procedures, laboratory equipment, and analytical methods. Your work will demonstrate that products perform consistently as intended, acting as the Quality Assurance signature for all process, cleaning, and analytical test method protocols.

As a Subject Matter Expert (SME), you will lead continuous improvement initiatives to streamline validation processes, removing unnecessary tasks and paperwork. You will provide leadership and guidance for validation-related CAPA activities, participate in Quality Risk Management by developing FMEAs and Risk Control Plans, and administer the Validation Review Board. This role requires a high degree of initiative and decision-making to perform efficiently with minimal supervision while fostering excellent interpersonal relationships with direct reports, peers, and supervisors.

Hiring Process

Applicants are encouraged to review the full job description and qualifications before applying. The role requires fluency in both Spanish and English, both verbally and in writing, alongside a background in regulated industries.

Equal Opportunity

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives, and serving our community. We consider qualified applicants regardless of background. Veterans and individuals with disabilities are encouraged to apply.

For US and Puerto Rico applicants seeking a reasonable accommodation, please visit our dedicated page to learn more about the process.

Work location

Work model: On-site

Paseo de las Alas, Carretera Mario Maldonado Torres, 00617, United States

Key Responsibilities

check_circleProvide quality oversight and approval for qualification and validation activities
check_circleAdminister and control the validation program for equipment, processes, and facilities
check_circleMaintain the Validation Change Control Program and Validation Management System
check_circleCreate validation documents including plans, technical reports, and position papers
check_circleLead continuous improvement projects to streamline validation processes
check_circleParticipate in Quality Risk Management and develop FMEAs and Risk Control Plans
check_circleAdminister the Validation Review Board
check_circleReview and approve the Validation Master Plan
check_circleAudit and approve process validation, cleaning, and analytical test method protocols
check_circleConduct training related to validation, qualification, and change management

Requirements

verifiedBachelor Degree in Sciences (Chemistry, Biology, Microbiology, Engineering or other technical/scientific area)
verifiedEight (8) years minimum of experience in quality assurance or related field
verifiedFluent in Spanish and English, both verbal and written

Nice to Have

Previous experience in Quality Risk Assessment, Change Management, and Cleaning Validation.

Benefits & Perks

check_circlePaid time off including vacation, holidays, and sick leavecheck_circleMedical, dental, and vision insurancecheck_circle401(k) retirement plancheck_circleEligibility for short-term incentive programs

Skills, education and keywords

Skills: Process Validation, Cleaning Validation, Test Method Validation, Analytical Instrumentation Qualification, Quality Risk Assessment, Change Management, Fmeas, Risk Control Plans, Spanish, English.

Education: Bachelor Degree in Sciences (Chemistry, Biology, Microbiology, Engineering or other technical/scientific area) required.

Frequently asked questions about QA Validation Manager at AbbVie

What does a QA Validation Manager at AbbVie do?expand_more

In this QA Validation Manager at AbbVie role, you will provide quality oversight and approval for qualification and validation activities; administer and control the validation program for equipment, processes, and facilities; maintain the validation change control program and validation management system; and create validation documents including plans, technical reports, and position papers.

What are the requirements for this QA Validation Manager role?expand_more

To qualify for the QA Validation Manager at AbbVie position, applicants should have: Bachelor Degree in Sciences (Chemistry, Biology, Microbiology, Engineering or other technical/scientific area); Eight (8) years minimum of experience in quality assurance or related field; and Fluent in Spanish and English, both verbal and written.

Where is the QA Validation Manager role at AbbVie located?expand_more

QA Validation Manager at AbbVie is based in Paseo de las Alas, Carretera Mario Maldonado Torres, 00617, United States. This is a on-site role.

Is this QA Validation Manager job remote, hybrid, or on-site?expand_more

AbbVie has listed this QA Validation Manager role as on-site.

How much experience is required for this QA Validation Manager role?expand_more

QA Validation Manager at AbbVie typically requires 8+ years of relevant experience at the senior level.

What skills do you need for the QA Validation Manager role at AbbVie?expand_more

Key skills for QA Validation Manager at AbbVie include Process Validation; Cleaning Validation; Test Method Validation; Analytical Instrumentation Qualification; Quality Risk Assessment; Change Management; Fmeas; and Risk Control Plans.

What education is required for QA Validation Manager at AbbVie?expand_more

Educational requirements for this role: Bachelor Degree in Sciences (Chemistry, Biology, Microbiology, Engineering or other technical/scientific area) required.

What category does the QA Validation Manager role belong to?expand_more

QA Validation Manager at AbbVie is part of the healthcare & nursing job category on Recrutus.

QA Validation Manager