Director, Product Quality (Aseptic Manufacturing)

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 Twitter, Facebook, Instagram, YouTube and LinkedIn. 

*Please note that job level/grading my differ from country to country*

Purpose

Responsible for overall quality of AbbVie products which may include small molecule pharmaceuticals and/or biologics, combination products to ensure business objectives are met with regards to on time delivery of product while assuring compliance to local, divisional, and corporate policies and external agency regulations worldwide. Scope of responsibility can also include business processes required to support new product introduction, product monitoring or post-market quality systems. Products include regulatory starting materials, Active Pharmaceutical Ingredients (API), Intermediates or Drug Products produced by AbbVie plants or by third-party manufacturers, In Licensing relationships, or Co-Marketing relationships. Develops in concert with Regulatory Affairs, the appropriate regulatory strategies for product brands. Grade is commensurate on level of overall responsibility.

Responsibilities

• Aseptic Fill
• Lead a team of Quality professionals who are responsible for assigned products and/or business processes required for on-market product support (e.g. quality monitoring, supplier quality and/or post-marketing quality assurance).
• Core team member or lead of strategic programs; including Brand Teams, Product Transfers, Global Strategic Sourcing, Post-Market commitments, Due Diligence, Site Selection, and Approvals and Continuous Improvement.
• Develop and implement a global Product Quality Assurance strategy to support pharmaceutical, biologics, and combination products manufactured at AbbVie plants or third party manufacturing (TPM) facilities. Ensures alignment of Quality and Technical Agreements with the legal contracts that the commitments of the quality and technical agreements are being fulfilled.
• Support development of the legal supply agreements, contracts and letters of intent to ensure the appropriate quality, compliance, and regulatory aspects are met for the products and services covered and manage the organizations actions with the legal boundaries of these documents. Approves negotiated quality and technical agreement as a representative of AbbVie.
• Ensures business objectives are met as regards to on time delivery of product and to budget while assuring compliance to local and divisional land corporate policies where appropriate. Liaise with Research and Development, supply chain, medical safety evaluation and Commercial functions to ensure all market place issues are recognized by operations management.
• Key decision maker on product quality and regulatory conformance issues; reviews and approves plant Quality Assurance performance reports and financial plans. Directs the Quality Assurance initiatives for global sourcing projects.
• Reviews and approves budgets. Interfaces with internal audit teams to develop audit plans, reviews audit observations and responses and maintains a corrective action timetable.
• Monitors manufacturing operations for conformance with established procedures and requirements of corporate and governmental good manufacturing practices.
• Develops and executes global strategies related to product complaints management and stability assessment for all products globally.

Qualifications

•  Graduate Degree  Life Science or other technical discipline required.
• 15+ years of total combined relevant experience. At least 2 years Plant experience; at least 5 years in Operations, Research and Development or Technical experience. Plant operational leadership experience preferred.
• Expert knowledge and a comprehensive understanding of biological and/or pharmaceutical technologies.
• Capable of understanding and overcoming differing cultural and language obstacles to providing solutions that satisfy both functional and local objectives.
• Capable of analyzing data facts and informed opinion to direct the developments of effective action plans as well as the ability to problem solve.
• Credible working relationship with plants.

Key Stakeholders 

External Mfg. Business Relationships, Third Party Manufacturers Business Alliance, Operations or Commercial Brand Teams, Commercial, Global Supply Chain, Domestic and International AbbVie Plants and Affiliates, Regulatory Affairs, R& D, Reg. agencies

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

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• Salary range may vary by location (U.S. and OUS)

• 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.

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

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