At Inventprise, developing innovative and widely available vaccines is in our DNA. By producing targeted vaccines for populations worldwide, we're addressing global health inequalities and empowering people to live healthy lives-no matter where they live. Headquartered in Redmond, WA, our goal is to deliver affordable, effective vaccines at large-scale to Low and Middle Income Countries, as well as populations in the U.S. and around the world. Inventprise is committed to creating a diverse and inclusive workplace, where our people are inspired to do their best work. We're proud to have some of the world's most qualified industry scientists, researchers, and manufacturing professionals on our team, and strive to create a vibrant, dynamic presence in the Washington State Life Sciences environment.
What the Role Offers - VP of Quality
The Vice President of Quality (VP of Quality) leads all aspects of the company's quality strategy in alignment with quality standards and FDA regulations. This individual will leverage their knowledge and experience to build quality best practices, including programs and procedures, that support the full cycle of vaccine development. In addition to being an expert in the field, this individual will create and maintain a quality culture, implement a quality strategic plan, and establish strong quality standards. This role will collaborate with the Research and Development (R&D), Manufacturing, Materials, Clinical and Regulatory and Training teams.
What You Need to Succeed
Lead and manage the company's quality assurance and quality control operations.
Develop and implement annual strategic quality plans for senior management review and confirmation.
Develop, deploy and analyze critical quality-related policies and procedure in accordance with application domestic and international regulatory criteria (e.g. FDA, Health Canada, WHO, etc.) and industry standards (e.g. ICH, ISO, etc.).
Assure the establishment of appropriate quality performance metrics, and oversight of corresponding management reviews, to confirm suitable risk management / risk mitigation profiles.
Implement and oversee / maintain internal GMP compliance auditing and external CMO / supplier auditing programs - to achieve and assure substantial compliance with applicable company procedures.
Develop and manage internal supplier quality programs, including and conducting audits.
Develop, deploy, and verify data integrity programs and reporting in accordance with applicable company procedures, in alignment with corresponding regulations and industry standards.
Lead and implement quality continuous improvement efforts and mitigation strategies.
Serve as primary company liaison with regulatory agencies and standards organization, as pertains to regulatory submissions, inspections, registrations, et. Al.
Support executive leadership directives in support of prevailing business objectives, critical initiatives and / or expansion projects; to assure no adverse results assignable to the company's quality program.
Required Qualifications:
MSc in Microbiology /Biochemistry/Health Science or Masters Degree in a related field.
20 + years of professional experience, with 5+ years as a senior executive leading a quality organization at a biotechnology or biopharmaceutical company.
Experience leading quality programs in multi-valent conjugate pneumococcal, bacterial, viral and mRNA, vaccines strongly preferred.
Deep knowledge of quality assurance in the life sciences industry, including industry standards, and domestic and international regulatory criteria.
Established people leader with experience building, developing and scaling high-performing quality assurance and quality control teams.
Experience in developing and maintaining GMP compliance while partnering with external auditors.
Experience with sourcing and implementing quality technologies and programs (i.e. quality management systems, digital-twin platforms, lab scheduling software, predictive analytics, etc.)
Deep relationships in the quality space, including auditors, consultants and professionals.
Change management steward and leader.
Excellent written and verbal communication skills.
Physical Demands:
Ability to travel 50% or more both domestically and internationally.
Frequently use of office equipment that requires manual dexterity to operate (i.e. computers, phones, etc.).
Occasional carrying, handling, and reaching for objects up to 30 pounds.
Frequently sit or stand for long periods of time.
Mental Demands:
Requires operational discipline to consistently focus and execute work-related tasks, with a minimum of human error and supervision. This involves self-checking of work immediately upon completion, and the ability to find / correct errors.
Ability to elevate potential concerns/discrepancies to executive management in a timely fashion.
Ability to manage time effectively to coordinate multiple projects simultaneously.
Ability to use problem-solving techniques to ensure project goals are met.
Effective communication skills both verbal and written are necessary to communicate within different departments and with external clients, maintaining a professional demeanor.
Working Conditions:
Onsite position in Redmond or Woodinville, WA unless otherwise specified. Remote work required if travel is necessary.
Primarily this position involves working in an office environment.
Relocation assistance available.
Estimated Base Salary: $275,000 - $330,000 / yearly DOE
Benefits:
Medical, Dental, Vision, FSA, or HSA: Inventprise contributes 80% toward the Medical, Dental, and Vision coverage for the employee, and their enrolled spouse, and dependents. Medical plans are currently provided through Premera Blue Cross.
401(k) program: Inventprise offers both pre-tax 401(k) and post-tax Roth retirement savings plans, letting you decide how you want to save for the future. We also make an employer contribution of 3% of your total earnings each pay period, regardless of whether you contribute.
Paid Time Off: Generous PTO, in addition to paid holidays.
Stock & Bonus Plans: Employees are eligible to participate in the Company's Bonus and Stock plans.
Our People-First Philosophy
At Inventprise, you'll be part of a world-class team working on innovative vaccines and technologies that have global impact. Our people are an integral part of our strategy, allowing us to grow as a company and improve our performance year-over-year.
Our company was built on the belief that by working together, we have the ability to make the world a better place and improve lives. We have a growth mindset and are constantly looking for ways to enhance our contributions to improve global health. We believe that when we support each other and set high standards, we are able to do our best work.
Equal Opportunity Employer
Inventprise is an equal-opportunity employer. All qualified applications will receive consideration for employment without regard to race, age, gender, identity, sexual orientation, color, religion, sex, marital status, national origin, protected veteran status, disability status, or any other status protected by federal, state, or local law.