Senior Project Manager, QA

Quality Assurance Manager

Company Description : 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.

Job Description Purpose : Responsible for quality of assigned products which may include small molecule pharmaceuticals and / or biologics products, combination products, and medical devices 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. 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.

Responsibilities

• Maintains the primary quality lead with management oversight for project Quality activities and the team members to achieve on-time quality deliverables, high customer value, and profitable results.
• Leads the development of global Product Quality Assurance strategy to support pharmaceuticals, biologics, device and combination products produced at AbbVie plants as well as third party manufacturing facilities.
• Makes key decisions on product quality and compliance and regulatory conformance issues for sterile, biological, liquid, solids, and / or device products.
• Establishes and maintains relationships and open communication with Third Party Manufacturers, AbbVie plants, affiliates and other functional groups to maintain roles and responsibilities, identify potential projects and issues, obtain an in-depth understanding of the quality, compliance, and resource needs at each site and provide guidance on quality concerns.
• Communicates and negotiates with external companies' 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.
• Interfaces 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.
• Manages Quality Assurance elements needed to facilitate new product launches including Third Party Manufacturer's that provide products directly to distribution centers, or to AbbVie domestic and International plants for further packaging and / or testing.
• Supports the management of exception documents and Corrective and Preventive Actions.
• Develops product quality transfer process monitoring metrics.
• Supports the regulatory filings and marketing authorization dossiers by developing and / or reviewing of chemistry, manufacturing and controls documents and Drug Master files / Certificate if suitability of monographs of the Ph. Eur. Documents.

Qualifications

Bachelor's Degree in relevant Life Science, Engineering, or other technical discipline required. Technical or Analytical background required for problem resolution with technical, quality, product and or engineering related issues. Total combined years of experience. Minimum 8+ years. At least 3 years in Quality Assurance Operations Management; 5+ years in any of the following areas; Operations, Research and Development, Regulatory or Consulting. Direct Manufacturing Plant experience in a Pharmaceutical setting is preferred. Knowledge and a comprehensive understanding / expertise of some 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). Strong quality assurance / control, manufacturing, laboratory, technical support, regulatory, and / or validation background is required. Experience with FDA and other regulatory agency interactions and inspections is required. Familiarity with the requirements for third party external manufacturing. Possesses knowledge and a skill set to operate within an environment that requires a high degree of urgency, strong analytical and problem solving skills, positive interpersonal skills, ability to manage multiple complex tasks simultaneously, and capable of performing as leaders, members and individuals.

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 : 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. 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 and serving our community. Equal Opportunity Employer / Veterans / Disabled. US & Puerto Rico only.