Life Molecular Imaging (LMI) is a global, innovative R &D company focusing on the development and commercialization of molecular imaging radiopharmaceuticals for our approved F-18 amyloid PET tracer Neuraceq® and a pipeline of PET tracers in clinical development. Our vision is to create value for patients and physicians by improving early detection and characterization of chronic and life-threatening diseases leading to better therapeutic outcomes and improved quality of life.
Quality Assurance Manager - US
The QA Manager will be responsible for supporting maintenance and further development of the LMI quality management system and monitoring of our US contract manufacturers. The responsibilities below do not represent the entirety of the role but rather an overview of some of the key tasks. This position will be responsible for a large territory across the US and will work closely with German team internationally. Therefore, you must be able to work outside the normal business hours to support other time zones. This position is home-based and must reside in the Eastern Time Zone.
Key Tasks and Responsibilities
- Qualify and monitor contract manufacturing partners and suppliers including assessment for suitability and compliance to the applicable cGMP regulations and supervision for continuing compliance.
- Maintain a robust quality management system for a portfolio of quality management tools including management of deviations, OOS-results, change control requests, CAPAs) and technical complaints.
- Work closely with internal and external stakeholders to proactively communicate deliveries and deficiencies and be able to de-escalate tense situations.
- Perform and follow-up GMP-audits at contract manufacturing partners and suppliers.
- Support and further develop internal quality documents and standard operating procedures and cGMP documents.
- Establish, review, and implement quality standards, specifications, parameters, analytical testing, and manufacturing methods as well as validations in compliance with international regulatory requirements.
What we expect:
To be successful in this role, you must be able to work in a fast-paced, time sensitive critical industry, have an attention to detail with new and routine tasks. The ideal candidate will have a BS/BA in related field (chemistry, biology, pharmacy or equivalent) with minimum three years of QA experience in a pharmaceutical manufacturing or related field, preferably radiopharmaceutical. Further direct experience will be considered in lieu of education. We are looking for people who are just as passionate as we are to improving the lives of those with Alzheimer’s and other neurodegenerative diseases.
What you can expect:
LMI is seeking candidates who are up for a challenge while being supported by their coworkers, managers, and other divisions of a global company. You will be able to make significant contributions through your expertise. You can expect what YOU do to matter, as all our employees are an integral part of a global organization as well as the communities we serve.
Life Molecular Imaging, Inc. is an Equal Opportunity Employer. We believe what we do and our culture of “It’s More Than a Job. It’s Making Life Better” extends to creating a welcoming, safe, and inclusive work environment. If you have what it takes and the passion to make a difference, please apply.