Manager, Product Quality (Sterile)
Manager, Product Quality (Sterile)
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Salary Not Disclosed
1 Vacancy
Job Description
Purpose
Responsible for quality of assigned products which may include sterile 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 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.
- Performs final quality release of manufactured product lots for products and/or product lines prepared by Third Party Manufacturers.
- 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.
- 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 (i.e. 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.
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. Salary:$106500-$202500
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 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.
US & Puerto Rico only - to learn more visit & Puerto Rico applicants seeking a reasonable accommodation click here to learn more:
No
Employment Type :
Full-time
Employment Type
Full-time
