US-GA, Quality Assurance Manager SR0038929-MZ
Incumbent will be the QA Lead for Visual Inspection and Packaging operations supporting 3 production lines and will be required to partner with multiple manufacturing managers, Engineering, maintenance, and Manufacturing Sciences for rapid problem solving and influence decisions.
Serve as Subject Matter Expert (SME) by maintaining a high level of expertise in current regulatory requirements and apply knowledge for daily decisions.
Direct performance of in-depth internal assessments and evaluations by collecting and analyzing accurate, objective evidence regarding risks and their magnitude.
Develop plans to correct identified risks including areas of non-conformance and approve and device strategy to implement effective Corrective action plans.
Write, review, analyze and revise written Standard Operating Procedures (SOPs) and support development and review of Protocols, Qualifications, Regulatory Submissions, etc.
Review and approval of deviation investigation and change control records.
Participate in external assessments and audits by evaluating and solving product/process problems by providing technical, analytical and supervisory skills.
Manage up to 5 shifts of personnel including supervisors, and on the floor support of packaging and visual inspection operations, labels and printed material management, retentions sample and reject management.
Ensure batch reviews and deviations reviews are performed in a timely manner to ensure on time release of batches.
Communicate with other facilities and provide updates on deviations and batch release as necessary.
The incumbent will be responsible for providing Quality Operations support and oversight via direct staff supervision or process/area responsibilities to identify and assess regulatory and quality risks in activities and processes according to regulatory agency rules and guidelines and Takeda quality practices. This will include participation in multi-site projects in the role of QA/QO contributor, coordinator or lead.
The incumbent will be responsible to handle multiple projects, demonstrate effectiveness in task completion, decision-making, empowerment of others, exception management, training, problem solving and team leadership.
Strong interpersonal skills and great attention to detail are necessary. Must be able to influence decisions based on regulatory knowledge, and must have excellent problem solving, and verbal and written communication skills.
Must be a strategic thinker and be able to develop strategic objectives.
Must have the ability to manage people, encourage teamwork and drive actions based on strategy. The position will include the supervision of assigned personnel in achieving defined quality goals in an efficient, accurate and timely manner; evaluate, train and develop direct reports.
Must be a self starter who need minimal oversight and can identify gaps and develop required work flows to lead teams and achieve project and strategic objectives
Must have adequate computer experience (knowledge of Microsoft Word, Excel and PowerPoint, TrackWise, Delta V, MES systems)
Must have knowledge of FDA Regulations, Application of Good Laboratory Practices, and Application of Good Manufacturing Practices.
Preferred experience: Experience with visual inspection of parenteral drugs and packaging operations, electronic management systems.
Education: Must have a Bachelors Degree in the Physical or Biological Sciences and minimum of 5 years of experience in the pharmaceutical industry.
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Equal Employment Opportunity
Shire, a wholly-owned subsidiary of Takeda, is an Equal Opportunity Employer committed to a diverse workforce. Shire, a wholly-owned subsidiary of Takeda, will not discriminate against any worker or job applicant on the basis of race, color, religion, gender, national origin, ancestry, age, sexual orientation, marital or civil partnership status, pregnancy, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, application for military service, or membership in any other category protected under law.
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