Senior Manager, Quality

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 Quality Manager, Global Lab Compliance will play a crucial role in ensuring the highest standards of quality and compliance across AbbVie operations. This role will support the development, implementation, and maintenance of the Global Lab Compliance programs to mitigate risk and ensure adherence to AbbVie Quality Systems.  Responsible for effective implementation of assigned projects, which may include small molecule pharmaceuticals and/or biologics products, combination products, and medical devices to ensure business objectives are met regarding compliance with local, divisional, and corporate policies and external agency regulations worldwide. Acts as the expert for GxP and regulatory compliance with global regulations and is the primary Quality and Compliance representative for the AbbVie global network pertaining to manufacturing and laboratory activities and quality initiatives. This position may develop and supervise others.

Responsibilities:

• Supports development and implementation of laboratory compliance programs by aligning policies and procedures with organizational goals and objectives.
• Develops new regulatory policies, processes and SOPs and trains key personnel on them; evaluates regulatory risks of these policies, processes and procedures
• Develops and implements sustainable training programs to support compliance initiatives, ensuring that all personnel possess the knowledge and skills necessary to meet regulatory requirements and effectively utilize AI technologies.
• Collaborates with cross functional teams to ensure training programs are relevant, engaging and updated regularly to reflect changes in compliance requirements and advancements in AI technologies
• Facilitates the alignment of site operations with global decisions by effectively influencing and engaging local teams
• Analyses key performance indicators (KPI) to assess the effectiveness of quality control programs and initiatives, identifying areas for improvement and implementing targeted solutions
• Effectively manages and executes strategic business opportunities to improve business processes.
• Functions independently in high-level decision making for project related issues that have cross functional impact
• Employs logic and methods to independently and effectively problem solve. Probes multiple sources for answers. Rapidly understands, evaluates and identifies hidden problems and issues; develops solutions for more complex with little direction from management
• Makes good decisions based on a mixture of analysis experience and judgment
• Strong ability to multi-task and prioritize department goals while using resources effectively and efficiently

Qualifications

• Bachelor’s degree with 15+ years of Quality, PDS&T, and/or Regulatory experience
• Prior experience managing a QC laboratory or other technical/scientific group
• Strong knowledge of regulatory requirements and standards applicable to laboratory operations
• Experience developing and implementing compliance programs and conducting audits.
• Excellent communication and interpersonal skills, with the ability to collaborate effectively with internal and external stakeholders
• Strong analytical and problem-solving skills
• Basic understanding and working knowledge of the physical and chemical characteristics of the products, including raw materials, used, or manufactured by AbbVie
• Familiar with use of statistical quality systems, electronic document management, and laboratory information management

Key Stakeholders 

• Development, Manufacturing, Quality and Regulatory

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. ​

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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