Director, Medical Device - North Chicago, United States - AbbVie

Description

Purpose

Responsible for quality oversight for late-stage development and new product introduction of combination products and medical devices. Scope of responsibility can also include business processes supporting new product introduction including risk management. Builds and maintains relationships with R&D, R&D QA, Regulatory Affairs, E&PQA, S&T, ECM, PSM, and Global Supply Chain to align strategic initiatives. Develop regulatory strategies for brands with Regulatory Affairs.

Responsibilities

• Develop and lead a quality professional team responsible for quality oversight of late-stage development, design transfer, and pre-market readiness activities - conforming to worldwide standards/regulations throughout the NPI supply chain & departmental budget. Lead team to develop strong relationships with Contract Manufacturers, Suppliers of Customized Products, Suppliers, AbbVie plants, affiliates, & other functional groups. Help team understand each project's quality, compliance, and organizational resource needs. Align roles and responsibilities across functions.
• Ensure delivery of all quality elements needed to facilitate new product launches including partners that provide products directly to distribution centers, or to AbbVie domestic and international plants for further manufacturing, packaging and/or testing.
• Core team member representing QA on including Pipeline Teams, New Product Introductions, Governance Process, CMC Leadership Team, Product Transfers, Global Strategic Sourcing, Due Diligence, and Site Selection. Make primary decisions on product quality, compliance and regulatory conformance issues for device products and elevates medium and high-risk events to AbbVie management.
• Develop and implement a global New Product Introduction Quality Assurance strategy to support quality systems or product requirements associated with devices and combination products manufactured at AbbVie plants or at external partner facilities. Provide a Quality Assurance perspective during new product development and address resolution of quality and compliance issues.
• 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. Manage and approve organization's actions—like Quality Technical Agreements— as a representative of AbbVie, within the legal boundaries of these documents. Reviews and approves negotiated Quality Technical Agreement as a representative of AbbVie.
• Key decision maker on product quality, compliance, and regulatory conformance issues for device products. Complete quality reviews with assigned partners that identify and address quality, operational, and organizational issues. Interface with Quality Assurance audit team to develop audit plans, due diligence plans, and inspection readiness plans, review audit observations and responses, and maintain corrective action timetable.
• Provide support for quality audits, initial site approvals and due diligence activities. Direct and manage pre-approval inspection readiness at external partners to ensure regulatory approvals are obtained, with no delays to market entries. Actively participates and interfaces directly/indirectly with the FDA, EMA, MHRA, ANVISA, MoH, etc. for pre-approval inspections.
• Function as main Quality liaison between external partners and AbbVie Operations in support of commercial operations, new product introductions, and product transfers. Negotiates with external partners upper management to maintain a consistent level of quality and a level of expectation that will minimize compliance risks but also balance the cost of operating to provide AbbVie with the agreed service.
• Establish and maintain relationships and open communication with external partners, AbbVie plants, affiliates and other functional groups (R&D, Regulatory, Purchasing, etc.) to define roles and responsibilities and identify potential projects and issues. Obtain an in-depth understanding of the quality, compliance, and resource needs at each transfer site. Provide quality oversight and guidance for successful validations (processes, test methods, etc.) and qualifications.
• Communicate and negotiate with the external partner's quality organization to maintain a consistent level of quality and a level of expectation that will minimize compliance risks but also balance the cost of operating to provide AbbVie with the agreed service. Prioritize programs, initiatives, and problem solving with consideration for impact to timelines, resources and conflicting priorities.

Qualifications

• Bachelor's Degree in relevant Life Science, Pharmacy, or Engineering is required. Graduate degree preferred.
• Technical or Analytical background required for problem resolution with technical, quality, product and or engineering related issues.
• Total combined years of experience 15+ years. In the pharmaceutical, biologics, device, or combination product industry—a minimum of 5 years of experience in QA, R&D, and/or S&T. Minimum of 6 years Management and Supervision experience.
• Required regulatory inspection experience with direct interaction with regulatory inspectors.
• Expert knowledge and a comprehensive understanding of device technologies (e.g., prefilled syringes, autoinjectors, on-body injectors, infusion pumps, sterile administration sets) and process (e.g., injection molding, automated assembly).
• Possesses knowledge and a skill set to operate within an environment that requires a high degree of urgency, positive interpersonal skills, and ability to manage multiple complex tasks simultaneously.
• Capable of analyzing data facts and informed opinion to direct the development of effective action plans as well as the ability to problem solve without the benefit of precedent.
• The incumbent must be capable of understanding and overcoming differing cultural and language obstacles to provide solutions that satisfy Corporate, Divisional, regional, and local objectives to effectively manage the action plans that will resolve the issues.
• Strong leadership skills required to manage professional staff and effectively interface with senior leaders both internally as well as with external organizations. Capacity to perform as a leader, team member, and individual.
• Experience with the requirements for contract manufacturing.

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 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.