US-MA, Quality Compliance Manager SR0041195-MZ
This position will report into the Associate Director of Quality responsible for the oversight and management of Quality Compliance at the site. This individual will be responsible for managing portions of the quality system program development, implementation, continuous improvement and/or harmonization at the Massachusetts Biologics Operations (MABioOps) Manufacturing Site. Use of project management collaboration skills is essential for program success.
The individual in this position will be a high level contributing member of the Quality Compliance Team and will execute responsibilities with minimal management oversight. This individual will work to ensure the health of the Quality Management System at the site is maintained. Ensures that all facets of the QMS are established and executed on Site within the area of responsibilities. Effectiveness is demonstrated through KPIs and management reviews in line with Site Guidance. Escalation mechanisms as defined in Site Regulations are being adhered to.
This role works to build, enhance, harmonize and manage quality compliance at the site and is responsible for finding solutions and coordinating changes associated with the solutions.
This role will have responsibilities in some of the following areas:
Education & Experience Requirements
Essential: A minimum of a B.S. degree in science or engineering with at least 8+ years relevant experience executing, developing, and/or administrating GMP quality programs in cGMP biotech and/or pharmaceutical environments. Prior supervisory experience desired. Knowledge of FDA and EMEA regulations and a working knowledge of root cause analysis. Excellent interpersonal skills and the ability to communicate well orally and in writing.
Desired: Direct Biologic Pharmaceuticals experience
Key Skills, Abilities & Competencies
Complexity & Problem Solving
Monitors goals and projects and takes action as needed to ensure timely delivery of goals.
Internal & External Contacts
Contacts are primarily with other professionals within Takeda
Other Job Requirements
Travel between sites at MA Bio Ops sites is frequently required. Weekend or off-hours activity may be required to support business needs.
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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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