Manager, Validation Quality Systems - 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 – 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

The Manager Validation Quality Systems is responsible for providing quality assurance support to pharmaceutical products, cosmetics and biologics. This role will support the strategic direction to ensure business objectives are met. Specific areas of support include Validation Documentation, Change Management and CAPA. This position will also translate strategy into tactical objectives to deliver strategic plans. This position will ensure that all product, process or system related quality activities re in compliance with Corporate and governmental regulations.

Responsibilities

• Ensure proper integration and support of quality regulations for Active Pharmaceutical Ingredients (API), biologics and cosmetics
• Lead project teams in planning, preparation, review and approval of quality documentation.
• Responsible for implementing and maintaining the effectiveness of the validation quality system in compliance with Corporate policies, processes and procedures.
• Design effective quality systems, procedures and/or processes within cross functional teams to ensure compliance as well as efficiency throughout our quality system. May be required to prepare and present validation data for management or during regulatory audits (FDA, EMA, Anvisa, etc) and internal audits.
• Manage and oversee a group of validation engineers
• Support new product introduction for pharmaceutical products
• Support design and validation changes to existing products.
• Interact with internal and external partners for development of best practices in our validation quality systems and procedures.
• Perform assessments to determine compliance to validation processes and regulations to identify potential gaps and mitigate and implement improvements within our quality system.

• Bachelor’s Degree in Chemistry, Pharmacy, Biology, Microbiology, Engineering or other technical/ scientific area preferred.
• 8+ years’ experience in quality assurance, quality oversight or relevant experience.
• Leadership of technical professionals and in leading cross-functional teams.
• Technical knowledge in Validation in the following areas: Equipment Qualification, Process and Cleaning Validation are required
• Manufacturing Operations knowledge and familiarity with product, process, equipment, and facilities of pharmaceutical and biological related products.
• Knowledge of QA systems and GMP compliance requirements including regulations and standards affecting  biologics, and pharmaceutical products.
• Experience working in both team setting and independently. Works well with manager guidance while able to manage own time.
• Strong oral (with all levels of management) and written communication skills needed.
• Excellent interpersonal skills is a plus.
• Can lead medium to larger sized projects with increasing level of complexity and size to deliver tactical results that support strategic initiatives.

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. ​

• This job is eligible to participate in our long-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