QA Manager for Aseptic Core 1 - GPA

ROLE SUMMARY: Candidate will be responsible to provide leadership for QO floor support of Drug Product Operations, change control review and approval, record approvals, and project support within the Drug Product Quality Operations organization. This position will be responsible for supporting QO functions for one or more of the following areas: West Wing, GPA, SPA, Packaging, Inspection, and Warehouse operations. Provides guidance and coaching to QO colleagues and provides direction/approval of activities and decisions.  Cultivates and reinforces appropriate group values, norms, and behaviors.  Provides oversight to individuals and team on personal development, performance, and quality related issues.  Writes and delivers performance reviews and performs second level reviews as required.  Provides oversight of department, ensuring proper use of assets, budget, and personnel.  Communicates effectively with key customers and partners, both within the site and outside of it. ROLE RESPONSIBILITIES: This position leads a team of individual contributor direct reports with a wide range of quality responsibilities including: QO Deviations and Product Floor Support - a team of Quality Operations professionals who are responsible for supporting all planned and unplanned manufacturing deviations, review and approval of product and equipment change controls (including SOPs and master batch records). The incumbent is responsible for the development, mentoring, and performance management of a team of about 4-10 QO professionals. This position is responsible to maintain the structure to ensure that all quality commitments and timelines are tracked and met.  In addition, assist the senior leaders at the site in resource and budget preparations. QUALIFICATIONS Education:  BS/MS or PhD in Chemistry, Biochemistry, Microbiology, Engineering, Pharmacy or related science and minimum of 5 years of related experience.  Experience:  Minimum experience in a cGMP environment, as described above, with a strong working knowledge of a variety of quality systems and processes.  Prior experience in a people management role strongly preferred. The candidate must have demonstrated proficiency in organizational and project management skills and must be able to balance multiple priorities.  The candidate should have experience in at least several of the following: GMP, Regulatory (worldwide), deviation investigation, drug product lot release, aseptic manufacturing processes, product and process validation, laboratory testing and investigations, and batch record review. Communication: Excellent written and verbal communication skills with the ability to share vision, direction, and data with colleagues across all levels and in a wide range of different work groups including senior leadership and regulatory agencies. Reasoning Ability: Strong analytical and problem solving abilities. Last Date to Apply for Job: December 31, 2018 4695715
Salary Range: NA
Minimum Qualification
5 - 7 years

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