QA Program Manager Immunogen

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. Grade is commensurate on level of overall responsibility.

Maintains the primary quality lead with management oversight for project activities and the team members (within and outside of AbbVie) to achieve on-time quality deliverables high customer value and profitable results. Primary driver for the quality and compliance aspects of product transfers and organization optimization.

Participates in 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 (TPM) facilities.  Implements agreed strategy.

Performs final quality release of manufactured product lots for products and / or product lines prepared by Third Party Manufacturers.

Makes recommendations for key decisions on product quality and compliance and regulatory conformance issues for sterile biological liquid solids and / or device products and elevates medium and high risk events to AbbVie management. Ensures alignment of Quality and Technical Agreements with the legal contracts and that the commitments of the quality and technical agreements are being fulfilled. Helps facilitate resolution in cases where they are not.

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. Prioritizes programs initiatives and problem solving with consideration for impact to timelines resources and conflicting priorities.

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. Provides support for quality audits initial site approvals and due diligence activities. Leads and manages pre-approval inspection readiness as related to the third party manufacturers to ensure regulatory approvals are obtained with no delays to market entries.

Contributes to Quality Assurance 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 packaging and / or testing. Coordinates activities to support follow-up on compliant trend investigations for non-medical and medical (adverse events). Supports the management of exception documents and Corrective and Preventive Actions.

Completes management reviews with assigned Third Party Manufacturers that identify and address quality operational and organizational issues. Obtains and reviews summaries of the Annual Product Reviews (domestic) and Annual Product Quality Reports (EU) from the Third Party Manufacturer to ensure accuracy completeness timeliness and trends are identified and addressed in an appropriate manner.

Qualifications :

Bachelors Degree in relevant Life Science or other technical discipline or equivalent job experience required.

7 years of total combined experience.  At least 5 years in Quality Assurance Operations Management; 3 years in Operations Research and Development or Consulting.

Knowledge and a comprehensive understanding 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).

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.

Additional Information :

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 :

No

Employment Type : Full-time

Key Skills

Project Management Methodology,Project / Program Management,Program Management,Management Experience,Microsoft Powerpoint,Project Management,Microsoft Project,Budgeting,DoD Experience,Leadership Experience,Supervising Experience,Contracts

Experience : years

Vacancy : 1