- 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 productivity
- Supports 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:
- 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
- Responsible for ongoing compliance with and understanding of applicable policies and procedures, including GMP
- 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.
- 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
- Bachelor's Degree preferably in technical or scientific area (Chemistry, Pharmacy, Biology, Microbiology, or Engineering). Master's degree is highly desirable
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Manager, Quality Assurance - North Chicago, United States - AbbVie
Description
Company DescriptionAbbVie'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
Significant Work Activities -Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Qualifications
Qualifications
Applicable only to applicants
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