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Director of Quality Operations

Eisai Inc.

Baltimore, Maryland 21075
Job Status:
Full Time
1st Shift
Eisai Inc.
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Job Details

Eisai Inc. was established in 1995 and began marketing its first product in the United States in 1997. Since then we have rapidly grown to become a fully integrated pharmaceutical business. Eisai’s areas of commercial focus include neurology, gastrointestinal disorders and oncology/critical care. The company serves as the U.S. pharmaceutical operation of Eisai Co., Ltd., a research-based human health care (hhc) company that discovers, develops and markets products throughout the world.

Eisai has a global product creation organization that includes U.S.-based R&D facilities in Massachusetts, New Jersey, North Carolina and Pennsylvania as well as manufacturing facilities in Maryland and North Carolina. The company’s areas of R&D focus include neuroscience; oncology; vascular, inflammatory and immunological reaction; and antibody-based programs.

Eisai recognizes that we are the Company’s greatest asset. To this, Eisai is committed to providing us an enabling and empowering work environment that allows us to grow and thrive. In our diverse organization, we adhere to a strict commitment to our values of Integrity, Respect, Professionalism, Quality and Teamwork. We therefore invite you to explore this job opportunity or any others that may match your qualifications and interests.

This position leads and establishes strategic and technical direction for the GLIADEL Quality Operations organization, including quality assurance and quality control. Serves as the technical expert in the area of quality assurance, and analytical chemistry/pharmaceutical analysis. This position is responsible for establishing and maintaining the quality systems used throughout the Baltimore facility which ensure corporate compliance with current US and international cGMP for commercial product manufactured at Baltimore facility JOB REQUIREMENTS: Experience leading Quality Operations at a senior management/leadership level with proven ability to see the “big picture”. Ability to work independently within a self-sufficient organization Advanced degree (or BS degree with equivalent experience) in scientific study (i.e., Chemistry, Biology, etc.). 7+ years of progressively responsible QA/QC in the pharmaceutical industry with strong track record of regulatory compliance. Thorough knowledge of cGMPs and regulatory standards including their current application and interpretation by the FDA, EMA, PMDA and other worldwide regulatory agencies. Experience working with pharmacopeia; USP preferred. Experience in facilitating and supporting regulatory inspections (FDA, EMEA, PMDA, ANVISA, etc.). Strong understanding of manufacturing, sourcing, materials management, QA and QC. Demonstrated ability to innovate and develop new approaches to quality assurance, quality control and compliance acceptable to the regulatory agencies. Knowledge of system and process validation, including validation for computerized systems. Knowledge of total quality management systems and statistical process control. Strong interpersonal relationship skills; as well as excellent communication skills (oral and written). Ability to accurately and professionally communicate across the Gliadel, EDCS and Eisai organizations. Proven people management and development skills. Ability to understand what’s necessary to run the business; assess employee performance, organizational design, mentorship, accountability, provide guidance on employee development to address gaps and future staffing needs of the organization.

Here at Eisai, we are rewarded with highly competitive salaries, incentive awards, a comprehensive benefits package (Medical, Dental, Prescription and Vision Plans) 401k, Flexible Spending Accounts, Life and Disability Insurance, and other great programs.

Eisai is committed to a policy of equal employment opportunity for all employees and applicants. The Company also strives for a work environment free from discrimination and harassment. It is Eisai’s policy to comply with all applicable federal, state and local laws and regulations regarding nondiscrimination in employment and not to discriminate against any employee or applicant for employment on the basis of any protected status, including, but not limited to, race, color, national origin, religion, sex, age, disability, pregnancy, ancestry, creed, alienage or citizenship status, sexual orientation, gender identity and expression, marital status, military/veteran status, genetic information, or any other protected characteristic as established by law.

Eisai is an Equal Opportunity Employer – Minority / Female / Disability / Vet from tblHiringOrgDefaults<img height=1 width=1 border=0 src= />


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