Associate Director, QA Biologics (Hybrid)

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.

Essential Functions

• Product Oversight: Ensure products are released for further processing only if they meet all company policies, procedures, and regulatory requirements. This includes reviewing batch documentation and investigating deviations.

• Process Management: Assist in managing the entire transfer process, including Due Diligence, Feasibility Studies, Protocols/Reports, PPQ, PAI Readiness, and Quality System Oversight Implementation.

• Audit and Compliance: Maintain audit readiness, support regulatory inspections, manage complaints effectively, oversee change control, review metrics, and conduct annual product reviews. This also involves building effective quality systems and continuous improvement activities.

• Regulatory Compliance: Ensure compliance with all company policies/procedures and applicable governmental regulations (GMP, etc.), both domestic and international.

• Metrics and Reporting: Compile, analyze, and report metrics, identifying trends and root causes to develop new initiatives and process improvements.

• Team Leadership: Lead, manage, coach, and develop a team of professional staff.

Requirements

• Bachelor’s Degree (required) or Master’s Degree (preferred) with 10+ years of relevant experience in quality, technical, or scientific roles within the biopharmaceutical industry; OR, PhD with 5+ years of relevant experience in quality, technical, or scientific roles within the biopharmaceutical industry.

• Extensive knowledge of global GxP and regulatory requirements related to the drug development process.

• Significant experience with manufacturing operations, biologics, and aseptic manufacturing.

• Experience with highly automated parenteral manufacturing processes, including isolators, automated inspection, Manufacturing Execution Systems and electronic batch release.

• Competent in analyzing complex products, production, and testing issues.

• Demonstrated scientific problem-solving capabilities.

• Direct experience managing external partners such as CMOs and labs.

• Experience in batch disposition, deviation management, change control, and participation in regulatory inspections.  Able to handle a broad scope of quality assurance work, including reviewing documentation, communicating with individuals or larger groups, and influencing external partners.

• Prior experience managing professional staff, including leadership, development, and performance improvement.

• Ability to lead or work effectively with cross-functional groups and work successfully across boundaries.

• Strong technical aptitude with the ability to train and mentor others.

• Proven experience leading projects, tracking, and managing budgets.

• Strong interpersonal, communication (written and oral), coaching, motivation, negotiation, organizational, and persuasion skills to build strong relationships.

• Flexible and able to adapt to company growth and evolving responsibilities.

• Must be self-motivated, engaged, and able to perform moderately complex tasks independently.

• Ability to independently problem-solve and recommend solutions.

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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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