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Danaher Corporation Director of Quality, Sterile Drug Product Manufacturing in New York, New York

At Aldevron, we shape the future of medicine by advancing science in meaningful ways. Our team of dedicated, forward-thinking associates share this goal by combining best-in-class products and service with the ideal operating environment to lay the groundwork for vital new discoveries worldwide. We believe people are our most valuable asset. Whether this is your first step on a rewarding career path or are a seasoned professional ready to take your career to the next level, we hire the best from all backgrounds and experiences.

Aldevron is one of 10 Life Sciences companies of Danaher. Together, we accelerate the discovery, development and delivery of solutions that safeguard and improve human health.

Together, the 10 Life Sciences companies of Danaher accelerate the discovery, development and delivery of solutions that safeguard and improve human health.

Job Summary

The Director of Quality is responsible for the creation, implementation and maintenance of all Quality and release processes in compliance with all foreign and domestic regulatory and statutory requirements. This individual will help to provide the strategic direction and vision as well as the tactical leadership necessary to consistently improve.

Job Responsibilities

  • Maintains an up‑to‑date knowledge and provides expertise in the areas of Quality, Sterile Drug Product Manufacturing, Compliance, Design Controls, Risk Management, and Statistical Techniques

  • Establishes and implements metrics (process capability, control charts, measurement quality, etc.) for monitoring system effectiveness to enable sound quality decisions and to improve quality

  • Supports the company in assuring it is operating in accordance with applicable regulations, standards and guidance related to clinical and commercial activities and helps maintains positive audit results especially as it relates to sterile drug product manufacturing

  • Performs Management Reviews and advise management of any product or process related issues and make recommendations for improvements

  • Escalates significant issues related to product quality, violations or non-compliance to requirements and regulations as appropriate.

  • Establish in-process product inspection standards for aseptically produced and sterile drug products

  • Serve as the primary Quality subject matter expert (SME) with regulatory agencies and clients

  • Provide expert interpretation and application of regulatory guidelines to ensure operations, facilities and documentation meet internal aseptic and sterile standards and regulatory requirements

  • Oversee Aldevron’s quality program, including overseeing and assisting with the company’s auditing programs, as well as the review of SOPs, investigations, specifications, methods, validation reports, cleaning verification reports, analytical reports, and manufacturing records

  • Develop and enhance phase appropriate QMS programs that comply with industry standards for development through commercialization GMPs

  • Serve as the site's primary contact with both customers and regulatory agencies regarding quality/compliance issues as it relates to aseptic and sterile drug products

  • Manage lot review audit programs against GxP standards, FDA/EMA/ICH requirements, and other regulatory standards and ensure timely resolution of any identified issues

  • Create a culture of sustainable quality through quality and compliance programs such as risk assessments, change management, data integrity, right first time, quality councils and critical quality metrics

  • Author and/or review and approve Standard Operating Procedures (SOPs) associated with Quality department responsibilities

  • Report information back to the Executive Team on a regular and consistent basis to ensure rapid communication of Quality issues, including potential misconduct or issues of significant deviations with projects/product, to appropriate leaders and colleagues

  • Direct the generation and implementation of performance and training programs for Quality personnel

  • Hire, train, motivate, lead, develop, and evaluate staff assigned to the department, facilitating, and assisting in their growth within Aldevron

  • Establish goals, objectives, and measures to drive continuous improvement of the Quality teams

  • Provide leadership to staff by directing, mentoring, coaching, and developing them towards professional growth, enhanced job performance and career satisfaction

  • Perform other duties as assigned

Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions of the position.

Qualifications

  • 10+ years of relevant experience in a quality position, required.

  • 3+ years of that experience in a lead, supervisory or managerial position

  • Experience in a variety of areas of the Quality Management Systems, required

  • Direct experience with regulatory audits, including direct interface with inspectors, required.

  • Aseptic and sterile manufacturing experience required.

  • Bachelor of Science required, life science related field preferred.

    We believe in designing a better, more sustainable workforce. We recognize the benefits of flexible, remote working arrangements for eligible roles and are committed to providing enriching careers, no matter the work arrangement. This position is eligible for a remote work arrangement in which you can work remotely from your home. Additional information about this remote work arrangement will be provided by your interview team. Explore the flexibility and challenge that working here can provide.

#LI-LCS

When you join us, you’ll also be joining Danaher’s global organization, where 80,000 people wake up every day determined to help our customers win. As an associate, you’ll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful Danaher Business System (https://www.danaher.com/how-we-work/danaher-business-system) tools and the stability of a tested organization.

Danaher Corporation and all Danaher Companies are committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. We value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.The EEO posters are available here (https://www.dol.gov/agencies/ofccp/posters) .We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform crucial job functions, and to receive other benefits and privileges of employment. Please contact us at applyassistance@danaher.com to request accommodation. If you’ve ever wondered what’s within you, there’s no better time to find out.

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