Senior Manager/Manager Quality Systems and Compliance

Job Description

Senior Manager/BioTech Quality Systems & Compliance

Location: Brevard County, FL

Experience: 10+ years, Type: Full-time Exempt

Reports to: : Sarah Hunter, Sr. Director Quality

Direct Reports: N/A

Vaxxinity, Inc. is a U.S.-based, clinical stage biotechnology company, that aims to democratize health by bringing the efficiency of vaccines to chronic diseases. Vaxxinity has a proprietary technology platform that has enabled the innovation of synthetic peptide vaccines designed to treat and prevent chronic diseases, including Alzheimer's, Parkinson's, migraines, and hypercholesterolemia, as well as infectious diseases, including COVID-19. Vaxxinity has designed its pipeline to achieve a historic global impact on human health. With its headquarters on theSpace Coast of Florida,Vaxxinity also has an office inNew York City.

Why Florida? Because it's one of the best places to live in the United States:

• #2 Fastest Growing Tech Sector in the US- Bureau of Labor Statistics
• #18 Best Place to Live in the US- US News & World Report
• #5 Best Performing City- the Milken Institute, 2021
• Top 10 Best Cities for STEM Jobs-Forbes.com
• Viera VoiceViera leaps into the Top 10 of the Top 50 Master-Planned Communities across the country

You will collaborate with a group of inspiring colleagues who are working on disruptive projects, solving big problems, and having a huge impact on the world.Be science driven; communicate clearly, openly, and respectfully; unite in teams and collaborations; learn and help others learn; act with integrity and get sh*t done. Expect to grow, expect to be challenged, and expect the unexpected as we embark on this journey of democratizing health for all the world's citizens.

Role

We are searching for a polished, smart, passionate, caring, self-motivated Senior Manager/Manager Quality Systemsand Compliance. The ideal candidate brings wisdom, enthusiasm, integrity, focus and perspective to partner with internal and external teammates, ensuring our Quality Systems are built, maintained, and improved upon as we focus on continually meeting/exceeding the expectations of our regulatory partners. The incredibly diverse role will actively support the clinical development and commercial programs already in motion, help construct and strengthen the company's quality culture, and have an opportunity to shape Vaxxinity's future. The ideal candidate will possess an infectious, "can do" attitude, a willingness to experiment and continuously improve, and the courage to speak up on behalf of their teammates and patients.

Responsibilities (duties are not limited to the below and may evolve over time depending on business needs and individual expertise)

• Building, maintenance, and continuous improvement of a Quality Management System (QMS) that encompasses GxP regulations in a seamless and continuous process (clinical and commercial operations)
• Development and implementation of Quality policies and procedures that satisfy GxP and business requirements
• E-system design, installation, validation, and ownership for change control, CAPA, non-conformance, documentation, and learning management systems
• Management of Quality Council to ensure alignment with Quality Standards
• Manage the Quality Risk Management program and establishment of a Risk Register
• Leading inspection readiness activities for internal and external partners (clinical and commercial)
• Partnering with key teammates (internal and external) to ensure compliance with all GCP, GLP and GMP requirements
• Management of a robust GMP training program for all Vaxxinity employees
• Development and execution of a robust quality audit program

Education / Experience

• 10+ years related experience in biologics/biotech/life sciences/pharma

• B.S. in Biology, Chemistry, Engineering or related fields; Master or PhD preferred
• Working knowledge of US and Worldwide GxP regulations and experience with regulatory compliance inspections
• Compliance/QA experience at a pharmaceutical/biopharmaceutical with specific experience regarding management of Quality Systems specific to vaccine manufacturing
• Strong knowledge of GxPs related to clinical and commercial activities, including but not limited to GCP (FDA and ICH), safety monitoring, clinical laboratories, GLP, GMP, GxP
• Proven expertise in the design and implementation of electronic Quality Systems and processes
• The ability to workeffectivelyinsmallmatrix teams inafast-pacedenvironmentwithchanging priorities andahigh levelofurgency
• Demonstrated ability to develop, coach, and mentor teammates

Knowledge / Skills / Abilities

• MS Office Suite, Google Suite, technology savvy
• Clever, flexible and resourceful -- must be able to work independently and know when/how to ask for help
• Ability to stay calm, cool, and focused in stressful times and maintain a professional demeanor

• Highly motivated, a "roll-up-your sleeves" attitude to work requirements, able to multi-task and meet rigorous timelines

• Excellent project management and prioritization skills including ability to handle multiple tasks and work in a fast-paced, time-sensitive environment
• Proven high level capability to concisely communicate complex and controversial issues and drive to resolution
• A strong team player who supports their team and embraces ownership, accountability, and responsibility for the team's work
• Ability to influence decision making with or without authority, facilitate groups with diverse perspectives, across geographies, and bring teams to agreement
• Strong interpersonal skills that build productive relationships and influence others across the company

• Ability to give what it takes: demanding hours, with scheduling flexibility, with a start-up attitude of intense dedication
• Humility and the belief you can make the world a better place is highly desired

Values

• Be science-driven
• Communicate clearly, openly and respectfully
• Unite in teams and collaborations
• Learn and help others learn
• Act with integrity
• Get sh*t done

In compliance with the Equal Pay for Equal Work Act, the salary range for this role is $145k-$165k. This is not a guarantee of compensation or salary, as final offer amount may vary based on factors including but not limited to experience and geographic location. Vaxxinity also offers a variety of benefits including: health and disability insurance, 401(k) match, flexible spending accounts, EAP, parental leave, paid time off, and company-paid holidays. The specific programs and options available to an employee may vary depending on date of hire, experience level and location.

If you are interested in applying for employment and need special assistance or an accommodation to apply for a posted position, contact our Human Resources department at(321) 777-3000

Vaxxinity is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation, or any characteristic protected under applicable law. Vaxxinity will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.