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.
- 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
- 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
- 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
- TPM and TPC Quality management, including exception requests (ERs),change requests (CRs) and QTA
- Reviews and approves Quality system documents and records
- 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.
AbbVie is an equal opportunity employer including disability/vets. 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 disabled veteran, recently separated veteran, Armed Forces service medal veteran or active duty wartime or campaign badge veteran or a person’s relationship or association with a protected veteran, including spouses and other family members, or any other protected group status. We will take affirmative action to employ and advance in employment qualified minorities, women, individuals with a disability, disabled veterans, recently separated veterans, Armed Forces service medal veterans or active-duty wartime or campaign badge veterans. The Affirmative Action Plan is available for viewing in the Human Resources office during regular business hours.
重點工作內容: Continuous standing for prolonged periods (more than 2 consecutive hours in an 8 hour day)