Quality Assurance Manager
- Remote, Home Office, United States
- Employees can work remotely
- Department: Quality
Aurinia exists to make a difference in transforming people’s lives by delivering innovative treatments to patients living with serious, rare autoimmune and inflammatory diseases. From the earliest days of the company, we’ve applied an inventive, thoughtful, and responsible approach to developing therapies for people in need. Through our dedication, we relentlessly preserve and execute with integrity to reach our main objective, to improve patients’ health.
In addition to driving adoption of our approved therapy, LUPKYNIS™, for appropriate people with lupus nephritis, we are also actively pursuing a broader portfolio of innovative drugs for autoimmune disease.
Our strategy leverages the skills and knowledge of our incredible team and our deep experience in principled drug development and commercialization. Aurinia provides a working environment where individuals can thrive in a professional, creative, and inspirational atmosphere. Together, we are driven to make an impact for our patient communities as advocates and partners in innovation.
We are looking for a Quality Assurance Manager to join our Quality Assurance team who can bring a diverse skill set to a growing organization while providing broad advocacy for the continued improvement of quality standards and a quality culture across the organization. This is an exciting time to join Aurinia in either a remote or in-office capacity. Implementation and supporting all elements of the QA Quality Management System (QMS), completing internal and external audits, QA lead on development of new products including GLP studies, and QA oversight of GxP Computerized Systems.
- Oversight and administration of the QMS to ensure all elements are functioning correctly including the audit / inspection program, vendor qualification, customer complaints, change controls, deviations, lab investigations and resulting CAPAs.
- Plans and conducts internal and external audits as described in the audit plan, including generating the audit report, audit certificate and management of resulting audit findings and CAPAs.
- QA oversight of GxP Computerized Systems and ensures that computerized systems are suitably selected, validated, implemented, managed and system changes are handled appropriately.
- Following the Computer System Assurance (CSA) model, reviews and/or creates Computer System Validation (CSV) documentation in collaboration with IT when appropriate.
- Ensures appropriate oversight of GLP studies and vendors to meet internal standards and regulatory requirements. Addresses gaps and builds quality systems as required.
- Acts as a QA Lead with all departments to assist in the generation of metrics and oversight reports for senior management.
- Maintains up to date Quality Assurance Agreements (QAA) with vendors.
- Prepares and reviews Quality Assurance departmental procedures, policy documents, and memos when required.
- Provides GxP training to all staff, as required.
- Ensures that the Quality Assurance department’s duties are carried out promptly, effectively and efficiently.
- Participates in the Quality Management Committee as a subject matter expert.
- Completes trainings (self-read or classroom training) on required procedures with a passing quiz score and performs tasks as per written procedures.
- Other Duties as identified/assigned by management.
- Approximately 15-25% travel is expected.
- University degree or college diploma, combined with 5 - 8 years of relevant experience in the pharmaceutical industry.
- In-depth GxP knowledge and experience (Health Canada, FDA, EMA)
- Minimum of three (3) years in a supervisory/management role
- Preferred three (3) years experience with software for EDMS and QMS. Veeva experience is preferred.
- Preferred three (3) years experience with Computer System Validation (CSV) with Good knowledge and understanding of international regulatory requirements such as 21 CFR Part 11, GAMP5 guidelines, and EU GMP Annex 11.
- Experience with early-stage Biologic products is an asset
- Working knowledge of the different pharmacopoeias (USP, BP, EP, etc.)
- Excellent command of English language both written and spoken
- Knowledge of Microsoft applications
- Attention to detail and follow through
- Ability to work independently as well as in a team environment
- Motivated with an ability to make quick, informed decisions
- Well-organized, able to multi-task and coordinate several projects at once
All candidate information will be kept confidential according to EEO guidelines