Director Product Quality

Purpose

Responsible for overall quality of AbbVie products including small molecule pharmaceuticals and/or biologics combination products and medical devicescomplying with delivery time objectives; local divisional and corporate policies; and ext. agency regulations worldwide. Scope of responsibility can also include business processes supporting new product introduction product monitoring or postmarket quality systems. Products include regulatory starting materials Active Pharmaceutical Ingredients (API) produced by AbbVie or thirdparty manufacturer Intermediates/Drug Products. Acts as the principle quality global supply chain rep. with external manufacturing businesses. Builds and maintains relationships with TPM Operations TPM Business Alliance Commercial Global Supply Chain Domestic and International AbbVie Plants and Affiliates Regulatory Affairs R&D and S&T to align strategic initiatives. Develop regulatory strategies for brands with Regulatory Affairs. 

Responsibilities

List up to 10 main responsibilities for the job. Include information about the accountability and scope.

• Develop and lead a quality professional team responsible for assigned products transfer activities and endtoend product qualityconforming to worldwide standards/regulations throughout the NPI supply chain & departmental budget. Lead Product Quality Assurance Transfer Mngr.s to develop strong relationships with Third Party Manufacturers AbbVie plants affiliates & other functional groups. Help them understand each projects quality compliance & org. resource needs; & align roles and res
• Ensure delivery of all quality elements needed to facilitate new product launches including Third Party Manufacturers that provide products directly to distribution centers or to AbbVie domestic and International plants for further manufacturing packaging and/or testing.
• Core team member or strategic programs lead; including Pipeline Teams New Product Introductions Governance Process CMC Leadership Team Product Transfers Specification Approval Team Regulatory Starting Material Core Team Global Strategic Sourcing Due Diligence and Site Selection. Make primary decisions on product quality compliance and regulatory conformance issues for sterile biological liquid solids and/or device products and elevates medium and high risk events to AbbVie mngmnt.
• Develop and implement a global Product Quality Assurance strategy to support quality systems or product requirements associated with pharmaceuticals biologics devices and combination products manufactured at AbbVie plants or third party manufacturing (TPM) 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 organizations actionslike Quality and Technical agreements as a representative of AbbVie within the legal boundaries of these documents. Approves negotiated quality and technical agreement as a representative of AbbVie.
• Key decision maker on product quality compliance and regulatory conformance issues for sterile biological liquid solids and/or device products. Complete management reviews with assigned TPMs 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 preapproval inspection readiness as related to the third party manufacturers 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 preapproval inspections.
• Function as main Quality liaison between Third Party Manufacturers (TPMs) and AbbVie Operations in support of commercial operations new product introductions and product transfers. Negotiates with external companies 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 Third Party Manufacturers (TPMs) 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 indepth 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 TPMs 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 :

Qualifications

• Bachelors 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 chemical industrya minimum of 5 years of experience in Manufacturing and 4 years of experience in QA R&D and/or S&T. Minimum of 6 years Management and Supervision experience.
• Minimum of 5 years experience in a direct Plant pharmaceutical setting role. Required regulatory inspection experience with direct interaction with regulatory inspectors.
• Expert knowledge and a comprehensive understanding of biological and/or pharmaceutical technologies (sterile biological liquid ointments devices solid tablets and caplets suspensions granulations soft elastic capsules gel caps extended release products coating solutions and/or active pharmaceutical ingredients).
• Possesses knowledge and a skill set to operate within an environment that requires a high degree of urgency positive interpersonal skills 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 third party external manufacturing.

Key Stakeholders 

External Manufacturing Business Relationships Operations Third Party
Manufacturers Business Alliance Commercial Global Supply Chain Domestic and International AbbVie Plants and Affiliates Regulatory Affairs Research and Development.

Additional Information :

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

• 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 shortterm incentive programs. 

• This job is eligible to participate in our longterm incentive programs

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 Companys sole and absolute discretion unless and until paid and may be modified at the Companys 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 and serving our community. Equal Opportunity Employer/Veterans/Disabled. 

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Work :

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