The Director of Quality Assurance is responsible for leadership and direction of all aspects of the Quality Assurance (QA) function, to ensure appropriate level of compliance of the company’s clinical development activities and clinical trial material production with recognized regulations and guidelines.
The Director will establish quality plans and policies and report compliance activities and findings to Executive leaders on a regular basis. This individual will design, implement, and maintain QA and compliance programs and infrastructure – including an SOP system and training program – and perform internal and external audits. They will establish, maintain, and ensure effectiveness of quality programs and documentation to assure compliance in a GxP international regulatory environment. They will also serve as an in-house advisor on GxP compliance.
- Design and maintain Quality Assurance and GxP compliance for all aspects of Rion’s programs to support clinical studies and future product registration
- Lead, manage and mentor a team of QA professionals with varying degrees of experience and GxP expertise
- Provide GxP Quality Assurance oversight of all external vendors’ quality programs, including CROs, central labs, investigator sites, CMOs, and other key partners supporting clinical programs, including maintenance of quality agreements
- Write, review, approve and maintain Standard Operating Procedures
- Direct development and implementation of quality systems to ensure product reliability, quality, efficacy, compliance to applicable SOPs, GxP regulations and applicable country specific standards
- Oversees the tracking of follow-up/resolution of critical/major findings associated with internal and external vendor/supplier audits, as required
- Manages the overall corrective action/preventative action program resulting from routine and for-cause audits
- Creates, revises, and reviews quality management system-related documents, including policies, standard operating procedures (SOPs), and guidelines for the Quality Assurance functional area and the overall Quality Management System
- Provide expertise and guidance to Rion’s departments in interpreting and implementing governmental and agency guidelines to assure compliance
- Follow applicable regulations, including FDA, ICH, EMA, GxP, and Rion policies and procedures
- Responsible for deviations, product complaint investigations and GxP archives
- Ensure training programs throughout Rion meet GxP and ICH requirements
- Provide Quality Assurance input to Rion’s strategic goals in form of schedules, quality plans, and budgets
- Oversees Quality Assurance sign-off on all functional department policies, SOPs, and guidelines to ensure compliance with applicable regulatory and industry standards
- Manages Quality Assurance review and sign-off on all GMP documents (e.g. batch records, specifications, label proofs, protocols/reports);
- Oversees the release process for all pharmaceutical products, as appropriate, intended for investigational or commercial human use
- Oversees the document control process and systems as well as maintenance of employee training records
- Prepares, coordinates, and directs regulatory agency inspections or corporate partner audits of Rion
- Assigns tasks and supervises the work of Quality and Compliance personnel
- Responsible for coordinating the site Quality Assurance budget.
- Responsible for the site QA Operations quality system integration activities with other Rion Divisions
- Other duties as requested
- Assists Senior Vice President of Regulatory Affairs and Quality Assurance and functional direct reports in the implementation and maintenance of the Quality Management System at Rion for all FDA regulated activities required for the manufacturing, distribution, and commercialization of pharmaceutical products globally
- Collaborates with functional department heads/personnel to ensure that FDA regulated activities at Rion comply with US/Global regulations, ICH/GxP, international guidelines, and internal policies and procedures, as applicable
- Develops organizational strategy to support corporate goals, direction, and growth.
- Identifies, recruits, and retains talent.
- Demonstrates leadership skills: coaches/mentors/supports peers and direct reports
- Maintains transparent and concise communication by sharing organizational information through department meetings, one-on-one meetings, and other venues
- Keeps up to date with current regulatory guidelines and compliance regulations
- Bachelor’s degree, Master’s degree, or PhD with focus in Life sciences, or similar technical field
- 10+ years of relevant and current work experience in pharmaceutical industry Quality Assurance required
- 7+ 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 firstname.lastname@example.org.