Leads ongoing, daily departmental operations.
May include the supervision of assigned personnel in achieving defined quality goals in an efficient, accurate and timely manner; Interview/hire, evaluate, train and develop direct reports
Perform in-depth internal assessments and evaluations by collecting and analyzing accurate, objective evidence regarding risks and their magnitude. Assessments and information gathering may be through in-depth employee interviews, flow charting and other informational gathering techniques. Determine the logic, adequacy and effectiveness of processes, systems and related requirements. Develop plans to correct identified risks including areas of non-conformance, inform management and implement approved corrective action plans.
Write, review, analyze and revise written Standard Operating Procedures (SOPs) and submit procedural changes as needed to meet Corporate, Divisional, Plant, Regulatory Requirements, etc.
Support external assessments or audits.
Assist with audits of various reports (Protocols, Qualifications, Regulatory Submissions, etc.)
Serve as Subject matter Expert (SME) and provide training to local employees as needed on relevant area(s)
Other duties, tasks or projects as assigned.
Strong interpersonal skills and great attention to detail are necessary. Must be a strong team player with good problem solving, and good verbal and written communication skills. Must have the ability to manage people, encourage teamwork and drive decisions.
Must be able to handle multiple projects concurrently, have computer experience and have knowledge of FDA Regulations, Application of Good Laboratory Practices, and Application of Good Manufacturing Practices as appropriate.
Bachelor's degree in business/scientific discipline and one to three years of relevant experience. Bachelor's degree in the life sciences and experience with a medical device/pharma or other similarly regulated industry preferred.
This is a second shift position.
A little about us:
At Shire, we help people with rare diseases and specialized conditions live their lives to the fullest.