Job Opportunities

Vice President of Quality Assurance (QA-1024)

AN2 Therapeutics, Inc. (AN2) is a biopharmaceutical company focused on developing novel anti-infective medicines for patients with rare, chronic infectious diseases – including global and neglected tropical diseases – that have significant unmet medical needs for new therapies. Founded by a team of experienced industry leaders in infectious diseases drug research and development, we strive to provide patients with treatments that will restore their health and enable them to live productive lives. AN2 is a mission-driven company with a passion for improving global public health and a vision to accelerate development of novel medicines to treat serious infectious diseases and save lives worldwide. We believe our company thrives when all employees share this mission. 

AN2 is seeking a Vice President of Quality Assurance who will be responsible for building, leading, and managing GxP programs, activities, and staff to ensure compliance with global laws, regulations, and applicable guidance for the company. This position reports to the Vice President, Regulatory Affairs. This role is hands on, with direct involvement in the strategic design and implementation of a comprehensive Quality System (including Good Manufacturing Practice [GMP], Good Laboratory Practice [GLP] and Good Clinical Practice [GCP]) compliance for AN2’s manufacturing, distribution, test laboratories and clinical trial activities. In addition, this role will have QA oversight for Computer System Validation (CSV) activities, hold ultimate responsibility for product release and for managing QA resources to support QA activities, identifying GxP risks and recommending remediation plans as well as leading continuous quality improvement initiatives. 

Key Responsibilities:

  • Develop, implement, maintain, and communicate the AN2 quality strategy and programs
  • Provide leadership and strategic guidance in ensuring continuous compliance with all applicable internal and external regulations, standards, policies, and procedures related to the quality, regulatory status, and performance of AN2 operations, processes, and products
  • Ensure AN2 is current with all quality-related regulatory requirements and provide guidance to senior management on the implications of any new or updated requirements.
  • Identify, design, and maintain a fit-for-purpose electronic document management system (EDMS) across the GxPs by directing and providing oversight and input into the relevant quality systems and standards including but not limited to change control; documentation systems; quality procedures, standards, and policies; product complaints; quality system reporting; personnel training documentation and other related areas. Ensure the EDMS module(s) have the appropriate level of rigor and controls to ensure compliance with applicable regulations and guidance.
  • Create and execute a plan for ensuring a state of inspection readiness and continuous improvement including creation and execution of a Master Audit Plan; coordinate and lead health authority inspections, and follow-up on findings.

Qualifications and Experience:

  • Bachelor’s degree in a scientific discipline; advanced degree in life sciences preferred.
  • >15 years of GxP leadership experience, with at least 12 years in a pharmaceutical company focused on novel drug or biologic therapies.
  • Demonstrated and extensive hands-on experience in the preparation, review, and finalization of GxP policies, procedures, SOPs, trainings, and corrective actions for both early and late development programs
  • Knowledge of ICH Guidelines associated with regulatory submissions (BLAs and/or NDAs, INDs), vendor audits, health-authority inspections, and regulatory documents (CSRs, IBs, and clinical study protocols).
  • Ability to build and maintain effective internal and external relationships, including with cross-functional teams, individual contractors, contract research organizations, and other vendors.
  • Exceptional written and verbal communication skills and attention to detail essential; must display strong analytical and problem-solving abilities.
  • Excellent planning and organizational skills, including the ability to support and prioritize multiple projects, as needed, and to be flexible and resilient in the face of change.
  • Demonstrated strength in understanding and effectively applying current regulatory requirements in an emerging regulatory landscape.
  • Maintains expert knowledge of and familiarity with FDA/EMA/PMDA regulations and ICH guidelines as they pertain to Quality initiatives.
  • Demonstrated leadership to build a Quality organization while driving on time and high-quality results that are needed to achieve company objectives.
  • The Candidate will have a proven ability to be self-directed and operate effectively in an evolving organizational structure with minimal direction, with a willingness to work remotely or on site as business needs demand.
  • Experience delivering high-impact presentations to company leadership and Board members

By joining our small, highly dedicated and motivated team, you will experience a culture that is inclusive, supportive, and humble, yet challenging. We set our egos aside to collaborate for the benefit of the team, and most importantly, the patients in need of new therapeutic options. AN2 is a company with a passion for improving global public health. We approach our business using a double bottom line strategy – with the intention of a fiscal and social return - this is reflected in our Core Values and is the foundation of our company’s culture. We employ the industry’s best to create a corporate culture that is fun, humble, respectful, and fulfilling, and where employees feel that they are making a difference and feel inspired to bring their passion to work.  

We are an equal opportunity employer that values diversity, equity, and inclusion. We consider all qualified applicants regardless of race, sex, gender identity or expression, sexual orientation, age, religion, national origin, marital status, veteran status, or ability status. We will ensure that individuals who are differently abled are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment as provided to other applicants or employees. Please contact us to request accommodation.

Our open positions are managed through our Human Resources department. Unsolicited resumes from recruiting agencies, in advance of a specified agreement, will not be accepted. Resumes sent directly to our employees or our consultants from recruiting organizations will also not be accepted as referrals and do not obligate us to pay fees. 

Please send your resume to and include the job title and QA-1024 number in the subject.

* AN2 Therapeutics is based in Menlo Park, CA, but employees are currently working remotely due to the COVID-19 pandemic.