Job details

Sr. Manager, Quality Auditing

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 Sr Manager, Quality Auditing, will report to the Director Americas Quality Systems and Compliance. This position will manage the Global and Corporate audit programs for Eisai. This key position will conduct GMP audits of Eisai’s global suppliers including contract manufacturers, contract packagers, and contract testing labs.

This role is responsible for managing all aspects of the audit lifecycle including scheduling, planning, issuing agendas, executing, issuing reports, evaluating responses, requesting clarification, issuing CA/PA, and closing.

The role is responsible for working with key stakeholders to resolve quality issues with current vendor/suppliers, and partner with stakeholders to maintain overall supplier quality. Conducts global vendor audits for Eisai providers of raw materials, product contact consumables, contract organizations, warehouse / distribution in support of Eisai Commercial products (Parenteral dosage, Aseptic Manufacturing, Biologic formulations, and Medical Devices as needed). Performs due diligence assessments for potential new vendors, as needed.

Essential Functions

Manages Corporate 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 (globally, domestically and internally) including vendor/supplier 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).
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
Identify compliance risks and escalate issues to appropriate levels of management for resolution.
This position will require domestic and international travel, for approximately 40% of the time.

Requirements

Bachelor’s degree, preferably in Chemistry, Biochemistry or equivalent technical discipline is preferred.
8+ years of auditing in a pharmaceutical/biotech environment required.
8+ years’ experience in leading Audits and/or Regulatory Inspections, preferably domestic and global.
3+ years Biologics experience is required (QA or Manufacturing Experience)
Strong oral and written communication skills are required. Demonstrated ability to communicate and effectively perform in a global environment is strongly preferred
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.
A Knowledge of domestic and international regulations including FDA, EMA, PMDA and Health Canada, as well as ICH ISO and PIC/S guidance’s.
Auditing certification strongly preferred
TrackWise experience is preferred.
Ability to travel domestically and globally as needed is required.

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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