- Batch record review and release
- VCRs and validation protocols
- Lot disposition and/or finished goods and/or commodities
- APRs/PQRs
- Quality metrics
- Track and trend activities
- Change management
- Risk management
- Training
- Data integrity
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Manager, Quality Assurance - North Chicago, United States - BioSpace, Inc.
Description
Job DetailsCompany 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 Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.Job Description
Responsibilities
Defines strategy for staff to manage daily activities for planning and implementing the LRP.
Manages direct reports including hiring, setting performance expectations, reviewing performance and developing staff to support the Quality needs of the plant.
Evaluates and develops tools to enable staff to continually improve performance and maximize productivitySupports internal and external audits, providing responses and developing improvement plans
Provides an active role in implementation of policy and procedure in support of the Quality System for the plant. Reviews and approves Quality system documents and records
Leads or participates in strategic initiatives to improve the following when possible:
Performs in-process testing to support Quality on the manufacturing floor
Provides feedback and oversight for complaints, non-conformances and deviations, identifying improvements and responding to trends
Act as authorized person for product release to market
TPM and TPC Quality management, including exception requests (ERs),change requests (CRs) and QTA
Tests commodities and raw materials for product compliance and manages retained samples.
Reviews and releases batch records.
Significant Work Activities -Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Qualifications
Qualifications
8+ years of direct experience in biopharmaceuticals or related industry
4+ years of managerial experience
Demonstrated knowledge of Quality Assurance Operations
8+ years of experience in application of FDA/GMP regulations
Strong communication skills, tact and diplomacy
Demonstrated effectiveness in multi-disciplinary teams across the organization
Ability to represent Quality function effectively with senior management and external parties
Direct manufacturing experience is strongly preferred
Direct regulatory interface experience is preferred
Bachelors Degree preferably in technical or scientific area (Chemistry, Pharmacy, Biology, Microbiology, or Engineering). Masters degree is highly desirable
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.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 Companys sole and absolute discretion, consistent with applicable law.
AbbVie is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion.It is AbbVies 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.
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