Regulatory Affairs Specialist jobs in Madison, WI

Company Description

Endsulin (www.endsulin.com) is a cutting-edge pre-clinical gene therapy startup biotechnology company in Madison, WI. Our primary goal is to develop a gene therapy to treat diabetes for the millions of people suffering from diabetes worldwide. Endsulin is located at University Research Park in the Forward Biolabs co-working biotechnology incubator.

Job Description

The Director of Quality Assurance and Regulatory Affairs (QA/RA), you will be a part of the executive team with the primary responsibility of building and maintaining Quality Systems. This role is strategically important for the success of commercialization goals, ensuring continuous improvement and high-quality products enter emerging, regulated, and clinical global markets.

You will serve as the subject matter expert to the executive team and provide guidance in areas related to quality, compliance, regulations, and clinical documentation for global registration. By working closely with the leaders of the company across all departments, this position will introduce and lead transformational efforts for improving product quality and driving a culture of quality throughout the company.  Continuous improvement and ad-hoc issue resolution to drive improvement of quality operations, at the lowest costs and in full compliance of all relevant regulations and standards.

This role is ideally suited to a candidate who is self-motivated and excited by an opportunity to rise to frequent and diverse challenges.

Qualifications

Duties/Responsibilities

•  Responsible for development, implementation, maintenance, and overall success of the company’s quality and regulatory programs and strategies, including articulating quality standards and objectives, developing methods to embed quality into the product development and manufacturing processes, establishing vendor relationships and quality standards, and developing and implementing innovative programs to focus employees on improving product quality.

•  Develop, implement, and support a comprehensive regulatory compliance strategy to meet global market requirements for our products and ensure alignment with our overall business strategy.

•  Proactively partner with R&D, Marketing, and other groups to provide regulatory advice and guidance on meeting necessary requirements to place products on global markets.

•  Ensure that regulated processes and systems are always inspection ready.

•  Oversee the performance of internal and external audits.

•  Review, edit, and maintain all departmental policies and procedures, including trainings, CAPAs, ECRs, and ECNs.

•  Oversee the development of employees, talent, processes, and technology necessary to reach annual and long-term objectives as organizational leader for the QA/RA functions

•  Serve as person responsible for regulatory compliance (PRRC).

•  Other duties as assigned.

Skills & Abilities

•  Extensive experience hosting regulatory inspections and interacting with regulators

•  Strong understanding of global registration requirements and demonstrated track record of successful market access.

•  Experience with computer software validation (CSV) and implementation for QMS and ERP software packages, including user requirements gathering and specification development, process workflow documentation, validation script writing, and IQ/OQ/PQ test case execution

•  General understanding of ICH, cGMP, cGDP, FDA, ISO, MDR, Healthcare compliance and applicable regulations and industry standards regarding clinical research and regulation of medical devices

•  Effective manager with ability to mentor and develop members of the QA/RA teams through coaching and effective performance management

•  Proven ability to create culture of accountability and ownership

•  Proven track record with establishing and maintaining strong internal and external partnerships.

•  Must be able to work effectively at all levels in the organization in a matrix environment .and with external partners.

•  Must demonstrate excellent written and verbal communication skills and work well with diverse teams and stakeholders in multiple locations.

•  Must possess the ability to conform to shifting priorities, demands and timelines through analytical and problem-solving capabilities to meet deadlines and prioritize work on multiple projects.

•  Highly independent and self-motivated and integrates well within a team.

Physical Demands

•  Ability to remain seated for long periods of time while working on computer or referring to documents.

•  Must have manual dexterity to operate computer keyboard and standard office equipment.

•  Positions: Standing, walking, sitting, stooping.

•  Ability to travel.

Education

•  Bachelor’s degree required in a science, engineering field or related discipline.

•  MBA is a plus

Experience

• 10 years of QMS experience and demonstrated leadership experience.

•  Proficiency with ISO 13485, Good Clinical Practices (GCP), and Quality System Inspection Techniques (QSIT); CFR’s parts 210 &211.

Additional Information

All your information will be kept confidential according to EEO guidelines.