QA Validation Manager

AbbVie • Barceloneta, PR

1d

About The Position

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 - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com . Follow @abbvie on LinkedIn, Facebook , Instagram , X and YouTube.

Requirements

• Bachelor Degree in Sciences (Chemistry, Biology, Microbiology, Engineering or other technical/scientific area is required.
• Eight (8) years minimum of experience in quality assurance or related field handling validated/qualified systems on a regulated industry.
• High degree of initiative, decision-making, and responsibility which would enable the candidate to perform efficiently with a minimum of supervision.
• Exposure to FDA/DEA regulations and inspection.
• Excellent interpersonal relationships with direct reports, peers, and supervisors
• Must be fluent in Spanish and English, both verbal and written.

Nice To Haves

• Previous experience in Q uality Risk Assessment, Change Management and Cleaning Validation is highly desired.
• Previous L eadership experience, managing direct reports.

Responsibilities

• Provide Quality oversight and approval regarding qualification and validation in compliance with regulatory regulations/guidelines.
• Administer and control the Validation program which includes equipment, processes, utilities, facilities, computers, cleaning procedures, laboratory equipment, and analytical methods to demonstrate that product will perform consistently as intended.
• Responsible for the audit, pre-approval and post-approval of all process validations protocols, cleaning protocols and analytical test method protocol as the QA signature.
• Maintain and control the Validation Change Control Program for the validated/qualified systems and the Validation Management System (VMS).
• Review and approval of Validation Master Plan.
• Create validation documents, such as Soltraqs Change Plans, Validation Plans, Technical Reports and Position Papers.
• SME on process validation aspects (process changes, cleaning validation, dust controls, hold times, test method validation, analytical instrumentation qualification).
• Conduct training related to Validation, Qualification and Management of change.
• Responsible for continuous improvement aspect of process validation by developing and supporting projects to streamline process from unnecessary tasks and paperwork.
• Provide leadership and guidance for validation related CAPA activities.
• Member of the Quality Risk Management and participate in development of FMEAs and Risk Control Plans as validation SME.
• Administer the Validation Review Board.

Benefits

• paid time off (vacation, holidays, sick)
• medical/dental/vision insurance
• 401(k)
• short-term incentive programs

What This Job Offers

• Job Type: Full-time
• Career Level: Manager