Senior
Manager, Product Development Quality Assurance
Company Description
About AbbVie
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 including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.
Job Description
This role is primarily responsible for supporting AbbVie’s pipeline, by supporting batch disposition activities and ensuring high-quality clinical supplies that are compliant with global regulatory requirements and standards are delivered to patients. This is achieved by effectively partnering with the business, ensuring risks are mitigated appropriately and supporting efficient review of clinical supply batches to support continued uninterrupted access to clinical supplies. The successful candidate will be able to manage multiple tasks and adjust priorities based on supply needs. This position requires the ability to positively interact with multiple functional, mentor and coach peers, and quickly and effectively be able resolve batch record documentation related issues independently, ensuring schedules are maintained and material is readily available.
Responsibilities
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Review and approve batch records and release batches or analytical records.
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Write/ review/ approve processes/procedures and related documents.
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Lead/assist in the preparation and management of audits conducted by regulatory agencies, customers, and R&D GxP Compliance.
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Review draft and final regulation for impact to R&D business and incorporate procedural changes as necessary.
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Provide routine area specific management support (act as backup to manager for routine management activities).
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Support daily product release activities as applicable to the organization.
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Responsible for driving consistency and continual process improvements within PDQA through assessment and compliance of regulations and industry practice.
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Write/ review/ approve exception reports, including high impact and complex ERs impacting multifunctional areas.
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Actively lead/participate on assigned project team(s) to support the product development.
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Actively monitor the effectiveness of processes and quality of project work with management and propose and execute quality/process improvements.
Qualifications
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Bachelors (typically in life sciences (biology, chemistry, or engineering) and/or equivalent experience.
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Master’s degree is preferred but is not required based on commensurate experience.
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6+ years industry experience in Quality Assurance, production, testing of active pharmaceutical ingredients, drug products, drug development or other healthcare related field; less experience considered with advanced degree.
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Supervisory/ project management experience is a plus (not required)
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Broad understanding of pharmaceutical manufacturing processes (chemical and biological), analytical sciences, and worldwide -global requirements for GMP (D, EU, US) is preferred.
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Must be able to provide and defend the quality position, and effectively problem solve complex technical and quality issues.
Additional Information
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
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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.
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We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
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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 anduntil 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 - 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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