Director/Sr. Director, GCP/GCLP Quality Assurance (QA-1043)

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 Sr. Director/Director, GCP/GCLP Quality Assurance to be responsible for supporting clinical trials through quality oversight, program/study team training and consultation, risk assessments, continuous improvement exercises, initiatives and processes to ensure compliance with quality objectives, regulatory requirements and GCPs/GCLPs/GLPs. This position will report to the Vice President, Quality Assurance.

Responsibilities:

Study Support and Quality Systems

• Lead the clinical and nonclinical QA functions to develop, enhance and implement a quality system in accordance with ICH Guideline E6 (R2) Good Clinical Practice (GCPs), 21 CFR part 58 Good Laboratory Practices (GLP), and other global regulatory authority requirements, and industry practices
• Develop and implement QA GCP/GCLP/GLP systems, risk management and CAPA processes, and SOPs for internal and external oversight operations
• Identify controlled document improvements, creation and training needs within the GCP/GCLP/GLP space
• Collaborate and provide QA expertise in processes such as investigations, corrective and preventive action (CAPA) plans, trial protocol deviations, complaints, risk management, risk assessments, recalls, safety events/reporting, relevant regulatory submission sections, and trial documentation review
• Represent QA on clinical study teams and conduct QA review of clinical study protocols, study plans and protocol deviations

Vendor Qualification, Auditing and Monitoring

• Lead, develop and implement an early-stage clinical and nonclinical site quality audit programs in collaboration with study teams
• Design and execute risk-based audit plans/schedules in collaboration with clinical and nonclinical study teams, including establishment of appropriate quality compliance criteria, to assure compliance with regulations, guidelines, and standards
• Lead qualification, routine and for-cause audits of Clinical Research Organizations (CRO), investigator sites, laboratory and data management vendors as well as other clinical vendors to assess effectiveness of their QMS and compliance to approved clinical study protocols and contracts
• Conduct internal audits to assess effectiveness of AN2’s GCP/GCLP/GLP QMS and process compliance including Clinical Study Report (CSR) and Trial Master File (TMF) audits
• Timely issuance of audit plans, audit reports, audit observations, oversee audit response process and drive audits to closure
• Evaluate audit observation trends and compliance risks and escalate to QA Management, as required
• Collaborate to maintain the approved supplier list (ASL) for Clinical suppliers

Metrics, Trending and Reporting

• Reporting of key quality metrics, periodic quality reports and audits as needed
• Support the cross functional site Quality Management Review (QMR) meetings
• Ensure timely collaboration with AN2 staff to ensure any non-compliance is elevated appropriately and addressed in a timely manner

Training

• Conduct and coordinate annual GCP/GCLP/GLP training

Inspection Readiness

• Lead inspection readiness by strategizing, collaborating, executing, etc. plans/tasks to prepare and support impacted programs/study teams
• Ensure the clinical and nonclinical sites are audit ready and compliant at all times
• Participate (eg, host/co-host inspections, lead or support inspection back-room/preparation room activities) during regulatory agency inspections

Other Duties/Requirements

• Works cross functionally to solve problems and produce solutions that work for the broader group
• Works across all levels in the organization to deliver GCP/GCLP/GLP Quality
• Partners with external collaborators, contractors, and contract research organizations to fully support drug development activities
• Lead continuous improvement initiatives

Qualifications and Experience:

• BS/MS in biology, chemistry, life sciences or related field
• At least 10 years of experience in pharmaceutical / biotech / clinical research industry with significant experience in GCP/GCLP/GLP environment (title commensurate with experience)
• At least 8 years of direct QA experience in GCP/GCLP in pharma required; QA experience in GLP is a plus
• Prior experience with clinical and nonclinical studies and CRO oversight
• Prior regulatory inspection experience required (eg, hosting inspections, inspection readiness planning and execution, etc.)
• Strong knowledge of GXPs in a regulated industry
• Strong knowledge of regulatory requirements for the pharmaceutical or biotechnology industries (21CFR Parts 11, 50, 54, 56, 58, ICH E3, E6, E8)
• Working current knowledge of Quality Assurance methodologies
• Self-starter requiring limited task supervision
• Able to collaborate, influence and work effectively across multiple departments
• Able and willing to work at AN2 site, attend meetings, etc, on an as needed basis
• Able and willing to travel, up to 25% – domestic and international, consistent with project needs
• Able to make decisions based on company and/or quality policies and procedures
• Ability to read, interpret and apply quality standards, SOP’s, specifications and work instructions
• Strong data gathering, metrics development, and report generation skills
• Strong analytical and problem-solving skills
• Strong organization and detail skills
• Strong verbal and written communication skills
• Strong interpersonal skills
• Excellent MS Office, Adobe Acrobat Pro skills
• Strong Quality Management System knowledge and skills
• Proficiency in QMS or DMS platforms preferred

AN2 anticipates that the annual base salary for this position could range from between $200,000 to $255,000 and will depend, in part, on the successful candidate’s credentials for the role, including education, qualifications, and type as well as length of experience. Any offered salary is also based on internal equity, internal salary ranges, market data, and the position’s wage range. Compensation decisions are dependent on the facts and circumstances of each case. The successful candidate will also be eligible to participate in a performance-based bonus and stock programs, various benefits offerings, including, but not limited to, medical, dental and vision insurance, disability, life insurance, 401k retirement savings plan, and flexible paid vacation.

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 careers@AN2Therapeutics.com and include the job title and QA-1043 number in the subject.