QA Validation Manager

Company Description

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

Job Description

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.

Responsibilities

• 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.

Qualifications

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

Additional Information

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: ​

• The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this postingbased on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more orless than the posted range. This range may be modified in the future. ​

• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.​

• This job is eligible to participate in our short-term incentive programs. ​

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission,incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paidand may be modified at the Company’s sole and absolute discretion, consistent with applicable law. 

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community.  Equal Opportunity Employer/Veterans/Disabled. 

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