The Quality Assurance Manager is responsible for ensuring the site maintains its compliance to the global quality standards. This is managed by auditing site procedures against the global quality standards and maintaining current good manufacturing practices against industry guidelines. This position manages the site’s Quality Assurance team in establishing and maintaining quality in accordance with our site SOP’s, regulatory guidelines and cGXP compliance requirements. This position is also responsible for several key quality systems, including EQMS, LIMS and electronic lab notebook. The Quality Assurance Manager is responsible for training documentation for staff.
The Quality Assurance Manager will apply expertise and regulatory knowledge to support manufacturing lot release, including application of scientific and technical innovation as it pertains to Pharmaceutical Manufacturing. This role develops a lifecycle and systems-based approach to the design and implementation of Quality Systems and process controls. Frequently interacts with senior leadership, direct manager, peers, internal customers, external clients and other cross-functional peers across the company to gain alignment on sound quality decisions.
Rion is a clinical-stage biotechnology company based in Rochester, Minnesota. Rion was founded as a Mayo Clinic Employee Entrepreneurial Program startup company. Rion’s mission is to develop clinically impactful and accessible therapies using innovative regenerative medicine technologies based on extracellular vesicle science. Our proprietary exosome platform has the ability to address significant unmet patient needs in many fields of medicine; accordingly, we are actively pursuing clinical programs in wound healing, cardiovascular diseases, and women’s health. Our ultimate mission is to deliver cutting edge solutions accessible to any patient in need, anywhere in the world.
Rion recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue career path their goals, both at work and in their personal lives.
We provide a very competitive compensation package with a unique culture focusing on development and wellbeing of our staff. Below are some of the benefits offered by Rion:
Rion is an equal opportunity employer and complies with all applicable federal, state and local fair employment practices laws. Rion strictly prohibits and does not tolerate discrimination against employees, applicants or any other covered persons because of race, color, religion, creed, national origin or ancestry, ethnicity, sex (including pregnancy), gender (including gender nonconformity and status as a transgender or transsexual individual), age, physical or mental disability, citizenship, past, current or prospective service in the uniformed services, genetic information, marital status, AIDS/HIV status, smoker/nonsmoker, and occupational pneumoconiosis or any other characteristic protected under applicable federal, state or local law.
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