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. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.
Job Description
Manage the day-to-day Coordination and Label Printing activities within Clinical Supply Management (CSM). The main objective of the coordination function is to convert the manufacturing requests into executable Batch Records for the Packaging Line. The main objective of the Label Printing function is to print clinical labels and inspect printed labels to ensure quality and blinding requirements are met. Manage cross functional initiatives around coordination/label room process improvements.
Responsibilities:
- Responsible for compliance with applicable policies and procedures. Accountable for compliance with global GMP and regulatory regulations and requirements in own area.
- Manage and supervise staff to ensure that all clinical studies start on time with no patient dosing interruptions. Assign, manage, and prioritize work for the Coordination team and Label Room personnel to ensure jobs are ready for execution to meet the packaging schedule.
- Coordinate pre-packaging and post-packaging activities including the generation of packaging instructions and packaging diagrams. Work with the Scheduling, Packaging and QA groups to coordinate the packaging schedule and batch record reviews to ensure all timelines are met.
- Develop tools to collect baseline and ongoing key performance metrics that measure and monitor the productivity and efficiency of the Clinical Coordination and Label Printing functions.
- Manage all aspects of human resources within area of responsibility. Coach, train and mentor staff to perform to company and department expectations.
- Ensure proper resourcing of each function within the area of responsibility. This includes assessing and addressing the need for OT, redistributing work among individuals, and leveraging cross training to temporarily reallocate resources to areas in need of support.
- Become SME for the Electronic Batch Records system. Translate new packaging scenarios into logical process steps and activities, help team members develop electronic batch records in an efficient manner, and troubleshoot system issues. Drive full implementation of eBR across all packaging types. Leverage eBR efficiencies to significantly reduce batch record TAT.
- Oversee the printing of more than 1,000,000 clinical labels per year, ensuring that optimal print quality and operational effectiveness are achieved. Make good judgments in determining acceptability of label quality and addressing blinding concerns.
Qualifications
- Bachelor’s Degree: Life or Physical Sciences preferred. At least 5 years work experience in pharmacy or pharmaceutical area. Understanding of the overall drug development and clinical development process.
- GMP batch record familiarity preferred
- Exception report/CAPA experience preferred
- GMP experience preferred
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 short-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, 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.
US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html
US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
https://www.abbvie.com/join-us/reasonable-accommodations.html
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