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Danaher Corporation Sr Manager, Quality Operations and Release in Fargo, North Dakota

Aldevron is an industry pioneer with a core competency in manufacturing for gene and cell therapy. We supply high-quality plasmid DNA, mRNA and proteins to our clients, who are breaking new ground on the world’s most important and challenging solutions to benefit us all. We're looking for innovative, forward-thinking individuals who share our goals of advancing science and making an impact on the world.

Aldevron is proud to work alongside a community of nine fellow Danaher Life Sciences companies. Together, we are pioneering the future of science and medicine, developing products that enable researchers in the fight to save lives.

About the role

This Senior Manager of Quality Operations and Release position is responsible for performing all duties related to the Product Release, Incoming Quality Assurance, Operational Quality Assurance, and Quality Engineering. This individual will manage, coach, mentor, and train the Quality Assurance groups responsible for the direct oversight of biological manufacturing operations, the inspection and release of all raw materials and components required for production, and the final process and documentation review necessary for the release of any material. This individual will also help drive continuous process improvement and work to maintain quality compliance programs that ensure that the manufacturing and production processes meet the highest quality, company, regulatory, and statutory standards that protect patient safety and product quality.

Primary Responsibilities

  • Provide daily leadership and management for the teams that report into this position to drive excellence in quality related functions.

  • Work directly with clients to negotiate and execute Client Quality Agreements

  • Drive the development and implementation of new processes and procedures that will enhance efficiency and compliance

  • Proactively identify potential quality risk areas and then recommend and support the implementation of appropriate corrective and preventive actions.

  • Training, mentoring, and coaching the staff within the department

  • Communicate regulatory compliance requirements and the company’s Quality standards to the entire Quality team, Site Managers, and the Site Leadership Team

  • Ensure that all company, client, regulatory, and statutory requirements are met before full product release

  • Optimize all processes related to incoming inspection, shop floor auditing, and batch record review

  • Interact and partner with our operational counterparts to build strong relationships, to enhance and improve our Quality culture, and reduce the number of non-conforming events encountered during manufacturing.

  • Write, review, and revise standard operating procedures as needed.

  • Works productively with cross functional teams within the organization in order to proactively resolve issues.

  • Participates in any issues that require management escalations

  • Provide support for internal projects in order to ensure that everything is appropriately documented.

  • Maintains effective and collaborative internal customer relationships

  • Maintains strong communication networks with peers

  • Additional responsibilities as assigned

Required Qualifications

Experience:

  • Two to five years of experience in a Quality preferably in a Quality Assurance capacity

  • Experience working in a regulated or GMP compliant environment

  • Current or past Quality certifications a plus (e.g. ISO 9001, ASQ, etc.)

  • Any experience in cell and therapy or biological manufacturing is a plus

  • Bachelor of Science, required; life science related field, preferred or equivalent experience

  • Experience in process understanding as it pertains to cGMP manufacturing and QA release

  • Comprehensive understanding of cGMP manufacturing expectations

  • Ability to works independently or as a team player when cross-functional involvement is involved

  • Critical thinker with strong decision-making skills

  • Exposure to regulatory agency inspections or other types of audits (e.g., FDA, notified bodies, ISO, etc.).

  • Leadership or team management experience

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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