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 – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.

Purpose

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 or Engineering (preferred)
• Eight (8) years minimum of experience in quality assurance or related field handling validated/qualified systems within the Pharmaceutical or Biotechnology industries.
• Background in Cleaning Validation is highly preferred. 
• Previous experience managing direct reports is required. 
• High degree of initiative, decision-making, and responsibility which would enable
• him/her to perform efficiently with a minimum of supervision.
• Exposure to FDA/DEA regulations and inspection.
• Excellent interpersonal relationships with subordinates, peers, and supervisors
• Must be fluent in Spanish and English, both verbal and written.

Key Stakeholders 

Quality Organization, Site Management,Plant Operations and NPI group.

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

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• 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 posting based 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 or less 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. ​​

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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 paid and 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, serving our community and embracing diversity and inclusion.  It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.

US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html 

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

https://www.abbvie.com/join-us/reasonable-accommodations.html