Back to jobs
New

Director, Clinical Quality Assurance

Remote (PST Zone) with up to 25% global and domestic travel

Position:          Director, Clinical Quality Assurance
Department: Global Clinical Development
Location:         Remote (PST Zone) with up to 25% global and domestic travel
Reports To:    VP, Head of Global Clinical Operations

Position Summary

The Director of Clinical Quality Assurance will be responsible for ensuring quality and compliance of Angitia sponsored clinical studies with respect to Standard Operating Procedures, applicable regulatory requirements (FDA, ICH, other country specific requirements) as well as supporting the non-clinical team on ensuring GLP studies are conducted compliantly. This role will work closely with the Heads of Quality Assurance (QA), Clinical Operations and Translational Sciences. This position reports to the VP, Head of Global Clinical Operations but may transition to Quality Assurance as that group grows.


Responsibilities

  • Drive and cultivate a culture of quality throughout the company to help ensure compliance with all applicable regulations, guidelines, and corporate standards, policies, and procedures.
  • Provide QA oversight and support to internal staff in support of Angitia sponsored clinical studies and GLP studies.
  • Development and management of processes and controlled documents related to Angitia sponsored clinical studies (clinical operations, clinical development, pharmacovigilance, regulatory) and GLP studies (translational medicine).
  • Prepare for health authority audit readiness.
  • Develop phase-appropriate Clinical QA operating models in accordance with ICH risk-based compliance guidance; set a strong foundation for future commercial operations.
  • Develop and implement audit plans and schedule for clinical study vendors and other study related GxP vendors (CROs, central /specialty labs, imaging, etc.).
  • Oversee and/or perform site and vendor audits to assure quality assurance compliance with regards to all internal as well as applicable regulatory guidelines.
  • Lead selection of contract auditors to perform site and vendor audits as needed.
  • Ensure timely and effective follow up to all identified or assigned quality issues.
  • Conduct QA review of Angitia sponsored clinical study documents, internal controlled documents and vendor documents.
  • Train internal staff on regulatory requirements such as GCP training.
  • Ensure training compliance and completion for Clinical Development, and potentially others.
  • Identify critical compliance and/or business issues related to GxP, CROs, Contract Test Laboratories and manufacturers of critical starting materials. Create and execute remediation strategies and tactical plans as needed using a risk-based approach.
  • Develop and oversee study quality metrics for clinical studies including study risk assessment, mitigation and CAPA management.
  • Coordinate and host all FDA and Health Authority inspections.  
  • Ensure all Quality agreements are effectively negotiated to meet the near- and long-term needs of Angitia as agreed with legal, finance and functional heads.  
  • May require up to 25% travel.

Qualifications

  • BS BA (or equivalent) in a relevant scientific discipline; advanced degree desirable.
  • 10+ years of Biotechnology industry with at least 8-12 years' experience in Quality Assurance, or equivalent levels of education and / or experience.  
  • Strong knowledge of GCP, GLP, and ICH clinical study requirements.
  • Experience with both domestic and international clinical studies (CDE, EMA and FDA regulations).
  • Experience building a quality program and quality system in young, science-driven organizations.
  • Experience leading audits of GXP vendors as well as clinical sites. 
  • Demonstrated problem-solving and critical thinking skills.
  • Excellent interpersonal, written and verbal communication skills.
  • Excellent computer skills in the following programs: MS Word, PowerPoint, Excel. And others.
  • Able to travel domestically and internationally up to 25% of the time.

Salary: $180,000 - $230,000

About Angitia

Established in June 2018, Angitia Biopharmaceuticals is a clinical-stage biotechnology company focused on the discovery and development of innovative therapeutics for serious musculoskeletal diseases. Angitia is currently studying 3 biologic product candidates in the clinic for the treatment of osteoporosis, osteogenesis imperfecta (OI), and spinal fusion. Leveraging the team's extensive experience and scientific acumen in novel drug development, Angitia is committed to providing groundbreaking therapies to satisfy key unmet medical needs. The founder and the core team members of Angitia are seasoned scientific leaders in new drug discovery, development, and management from both overseas and domestic large multinational companies. The company has built an organization with offices in Westlake Village, CA and Guangzhou, China that is distinguished by world-class scientists with talents that are proficient in the pathophysiology of musculoskeletal diseases. We utilize cutting-edge technologies of genetics and molecular biology to uncover new mechanisms, signal transduction pathways and their interactions combined with computer aided drug design to identify new drug targets, and to discover and develop new biological and small molecule medicines. The company is committed to serving patients in need by carrying out innovative science including internal research and external collaborations with academics and global biopharmaceutical companies. We are seeking talented individuals who are innovative, ambitious, and great team players to join our vibrant group.

Learn more at www.angitiabio.com.

Benefits:

  • Medical, dental, and vision coverage for employees and their eligible dependents
  • 401(K) Retirement Plan with Company match
  • Company paid Long Term Disability Coverage
  • Company-paid life Insurance & AD&D Coverage
  • Voluntary Life Insurance & AD&D Coverage
  • Employee Assistance Program (EAP)
  • Company-paid Holidays
  • Vacation
  • Paid Sick Leave
  • Telecommunication Monthly Stipend
  • Work-From-Home Equipment Reimbursement

Create a Job Alert

Interested in building your career at Angitia Incorporated Limited? Get future opportunities sent straight to your email.

Apply for this job

*

indicates a required field

Resume/CV*

Accepted file types: pdf, doc, docx, txt, rtf

Cover Letter

Accepted file types: pdf, doc, docx, txt, rtf

Education

Select...
Select...
Select...

Voluntary Self-Identification

For government reporting purposes, we ask candidates to respond to the below self-identification survey. Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiring process or thereafter. Any information that you do provide will be recorded and maintained in a confidential file.

As set forth in Angitia Incorporated Limited’s Equal Employment Opportunity policy, we do not discriminate on the basis of any protected group status under any applicable law.

Select...
Select...
Race & Ethnicity Definitions

If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection. As a government contractor subject to the Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measure the effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categories is as follows:

A "disabled veteran" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability.

A "recently separated veteran" means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service.

An "active duty wartime or campaign badge veteran" means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense.

An "Armed forces service medal veteran" means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985.

Select...

Voluntary Self-Identification of Disability

Form CC-305
Page 1 of 1
OMB Control Number 1250-0005
Expires 04/30/2026

Why are you being asked to complete this form?

We are a federal contractor or subcontractor. The law requires us to provide equal employment opportunity to qualified people with disabilities. We have a goal of having at least 7% of our workers as people with disabilities. The law says we must measure our progress towards this goal. To do this, we must ask applicants and employees if they have a disability or have ever had one. People can become disabled, so we need to ask this question at least every five years.

Completing this form is voluntary, and we hope that you will choose to do so. Your answer is confidential. No one who makes hiring decisions will see it. Your decision to complete the form and your answer will not harm you in any way. If you want to learn more about the law or this form, visit the U.S. Department of Labor’s Office of Federal Contract Compliance Programs (OFCCP) website at www.dol.gov/ofccp.

How do you know if you have a disability?

A disability is a condition that substantially limits one or more of your “major life activities.” If you have or have ever had such a condition, you are a person with a disability. Disabilities include, but are not limited to:

  • Alcohol or other substance use disorder (not currently using drugs illegally)
  • Autoimmune disorder, for example, lupus, fibromyalgia, rheumatoid arthritis, HIV/AIDS
  • Blind or low vision
  • Cancer (past or present)
  • Cardiovascular or heart disease
  • Celiac disease
  • Cerebral palsy
  • Deaf or serious difficulty hearing
  • Diabetes
  • Disfigurement, for example, disfigurement caused by burns, wounds, accidents, or congenital disorders
  • Epilepsy or other seizure disorder
  • Gastrointestinal disorders, for example, Crohn's Disease, irritable bowel syndrome
  • Intellectual or developmental disability
  • Mental health conditions, for example, depression, bipolar disorder, anxiety disorder, schizophrenia, PTSD
  • Missing limbs or partially missing limbs
  • Mobility impairment, benefiting from the use of a wheelchair, scooter, walker, leg brace(s) and/or other supports
  • Nervous system condition, for example, migraine headaches, Parkinson’s disease, multiple sclerosis (MS)
  • Neurodivergence, for example, attention-deficit/hyperactivity disorder (ADHD), autism spectrum disorder, dyslexia, dyspraxia, other learning disabilities
  • Partial or complete paralysis (any cause)
  • Pulmonary or respiratory conditions, for example, tuberculosis, asthma, emphysema
  • Short stature (dwarfism)
  • Traumatic brain injury
Select...

PUBLIC BURDEN STATEMENT: According to the Paperwork Reduction Act of 1995 no persons are required to respond to a collection of information unless such collection displays a valid OMB control number. This survey should take about 5 minutes to complete.