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Quality Manager- Filling and Packaging

Shire is the leading global biotechnology company focused on serving people with rare diseases and other highly specialized conditions. We have best-in-class products available in more than 100 countries across core therapeutic areas including Hematology, Immunology, Neuroscience, Lysosomal Storage Disorders, Gastrointestinal / Internal Medicine / Endocrine and Hereditary Angioedema; a growing franchise in Oncology; and an emerging, innovative pipeline in Ophthalmics.   Our employees come to work every day with a shared mission: to develop and deliver breakthrough therapies for the hundreds of millions of people in the world affected by rare diseases and other high-need conditions, and who lack effective therapies to live their lives to the fullest. Incumbent will be the QA Lead for Filling, Visual Inspections, and Packaging operations of for large format protein solution product and will be required to partner with multiple manufacturing managers 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. Serve as Subject Matter Expert in Aseptic operations and visual inspection of parenteral drugs. 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 related to filling, visual inspections, aseptic operations 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. Ensure timely batch record reviews, deviation reviews, and issues resolution to ensure timely release of lots. 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. Education and Experience Requirements Bachelor's degree in science or engineering; advanced degree in the life sciences, physical sciences or engineering preferred.   Minimum of 5-8 years of related experience in pharmaceutical, biotechnology or related industry making Quality decision based on regulation requirements. Key Skills, Abilities, and Competencies 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 Mircosoft Word, Excel and PowerPoint, TrackWise, Delta V, MES systems) Must have knowledge of FDA Regulations, Aseptic Filling Operations,  Visual Inspection of Parenteral Drugs, Application of Good Laboratory Practices, and Application of Good Manufacturing Practices. Preferred experience: Isolator Filling Operations, Aseptic Operations and Media Fill Qualification, Visual Inspection, Packaging, Delta V automation and EBM; preferred Req ID: R0029664
Salary Range: NA
Minimum Qualification
5 - 7 years

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