At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is Eisai’s human health care (hhc) mission. We’re a growing pharmaceutical company that is breaking through in neurology and oncology, with a strong emphasis on research and development. Our history includes the development of many innovative medicines, notably the discovery of the world's most widely-used treatment for Alzheimer’s disease. As we continue to expand, we are seeking highly-motivated individuals who want to work in a fast-paced environment and make a difference. If this is your profile, we want to hear from you.
The Manager, Quality Auditing is responsible for quality oversight and management of the global audit program which includes audit schedule, on-going training of global auditors, maintenance of global audit policies and dissemination of lessons learned from audit findings. They are also responsible for external audits of the suppliers and vendors for the commercial and clinical products of the Americas Region sites and supports Regulatory Agency audits as needed. The individual will maintain audit files, audit schedules and audit lists for all vendors/suppliers of the Americas region external manufactured products. They will partner with the other global audit functions to exchange information and ensure the quality of all Eisai partnered vendors/suppliers.
The role is responsible for ensuring that all vendors and suppliers meet Eisai’s expected level of quality and GMP operations. Provides input on the acceptability of current and new vendors/suppliers for on-going projects, new entities and global projects. They will work with other stakeholders to resolve quality issues with current vendor/suppliers, and partner with stakeholders to maintain overall supplier quality.
The manager is highly independent given their extensive GMP and technical knowledge, as well as job-related experience. They will demonstrate effective teamwork by developing strong relationships with internal/external customers (domestic and global), peers and management.
The manager independently determines whether the vendor/supplier operates at a required level of GMP compliance to be an Eisai partner. The manager maintains the approved supplier list and maintains linkage as required in SAP.
The manager is responsible for the global audit program and interfaces with other global audit functions to support Eisai vendors/suppliers on a global basis. This position will require domestic and international travel, for approximately 40% of the time.
Essential Functions
Manages Americas Product Quality Region and Global Audit programs including audit schedule, on-going training of auditors, maintenance of audit policies and dissemination of lessons learned from audit findings.
Performs audits (domestically and internal) including vendor/supplier, internal audits of Baltimore, Exton and Raleigh and supports Regulatory Agency audits as needed. Provides direction as needed for staff performing audit functions. The individual may provide direction for contractors and audit staff (as applicable).
Performs audits in support of the Global Audit program
Writes audit reports and manages responses; documents audit closeout; all in a professional, timely and accurate manner.
Works with stakeholders to manage the quality of Eisai vendor/suppliers
Requirements
Bachelor’s degree, preferably in Chemistry, Biochemistry or equivalent technical discipline is preferred.
5+ years of auditing in a pharmaceutical/biotech environment required.
5 years’ experience in leading Audits and/or Regulatory Inspections.
Biologics Experience is strongly preferred.
Strong oral and written communication skills are required. Demonstrated ability to communicate and effectively perform in a global environment is strongly preferred
Demonstrated Ability to interpret and apply GMPs, relevant laws, guidances and directives to extremely complex pharmaceutical situations.
Attention to detail, ability to coordinate activities with multiple functional groups and outside vendors/suppliers with a sense of urgency.
Exercises independent judgement in evaluating internal and external operations.
Auditing certification strongly preferred
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Eisai requires all new hires to be fully vaccinated against COVID-19 and provide valid proof of vaccination as of their start date, to the extent permitted under applicable law. This requirement is a condition of employment at Eisai, and it applies regardless of whether the position is located at an Eisai site, field based or is fully remote. If you are unable to receive the vaccine for qualifying medical reasons (including pregnancy-related), or religious reasons (sincerely held religious beliefs), you will have an opportunity to request a reasonable accommodation.
Eisai is an equal opportunity employer and as such, is committed in policy and in practice to recruit, hire, train, and promote in all job qualifications without regard to race, color, religion, gender, age, national origin, citizenship status, marital status, sexual orientation, gender identity, disability or veteran status. Similarly, considering the need for reasonable accommodations, Eisai prohibits discrimination against persons because of disability, including disabled veterans.
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