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Careers

Quality Assurance Manager

Position Summary:

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.

Responsibilities:

  • Responsible for: materials acceptance and quarantine, batch release & record review, pharmaceutical quality control, equipment maintenance/qualification/calibration, investigation (IR,OOS) and corrective actions (CAPA), SOP writing, maintenance and review, inspection readiness, data quality and integrity and other routine QA functions
  • Establish, implement and maintain quality management systems to measure and control quality in our processes
  • Provide training to staff on QA activities and SOPs. Assure staff is qualified for assigned quality tasks with documentation of training and qualification. Maintain records for inspection
  • Trend deviations, investigations and OOS and document accordingly. Initiate investigation and assure documentation of corrective actions and retraining as applicable.
  • Ensure that all operations are compliant with cGMPs regulatory requirements.
  • Maintain records to comply with FDA and SOP requirements
  • Supporting lead for FDA and other agency, vendor and internal quality audits, as directed. Maintain site audit readiness by thorough records review.
  • Write, review, and approve SOP system documents to ensure cGMP compliance, as required.
  • Review and update Quality manual accordingly
  • Ensure proper root-cause analysis and implement corrective and preventive actions.
  • Performs other functions as required or assigned
  • Complies with all company policies and standards

Minimum Qualifications:

  • Bachelor’s degree or Master’s Degree with focus in Life sciences, or similar technical field
  • Minimum of 7 years of relevant and current work experience in pharmaceutical industry Quality Assurance required
  • 5+ years of demonstrated management experience with evidence of being an impactful, influential, and involved leader and mentor
  • Excellent communication skills and abilities to collaborate with and present to individuals of varying levels of authority, including senior and Executive leadership
  • Solid and demonstrable knowledge of international GxP regulations and guidelines, industry practices, and experience implementing Quality Systems in a regulated environment
  • Working knowledge of GxP international regulations
  • Strong organizational and time management skills
  • Attention to detail with an ability to perform critical review of various types of documents
  • Outstanding written and verbal skills
  • Ability to independently solve problems and work cross-culturally
  • Demonstrated ability to work as a team player with multi-disciplinary project teams

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:

  • Full Health, Dental and Vision Insurance for employees and their dependents.
  • Health Insurance including PPO or High Deductible Health Plan with Health Savings Account.
  • Dental Insurance
  • Vision Insurance
  • Flexible Spending Accounts (FSA)
  • 401k or IRA Retirement Savings
  • Life Insurance basic life and supplemental life insurance options for self, spouse, children
  • Short and Long-Term Disability Insurance
  • Paid Time Off
  • Paid Holidays
  • Parking benefits

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.

Please send your resume and cover letter to careers@riontx.com.