Quality Assurance Senior Manager
Quality Assurance Senior Manager
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Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
Purpose
To provide strategy for Quality staff by managing daily activities with consideration to the LRP. Strong decision making and communication for issue resolution within the Quality System.
Responsibilities:
- Responsible for ongoing compliance with and understanding of applicable policies and procedures including cGMP
- 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.
- Quality oversight of drug product manufacturing and finished good packaging as well as batch record review and batch release.
- 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
- Member of the change review board reviewing and approving validation documents and change controls
- Provides feedback and approves nonconformances and deviations identifying improvements and responding to trends
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 multidisciplinary 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 shortterm incentive programs.
This job is eligible to participate in our longterm 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 :
Fulltime
Employment Type
Full-time
