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Angitia Biopharmaceuticals · 2 months ago

Director, Clinical Quality Assurance

Westlake Village, CA

Full-time

Onsite

Director/Executive

$200K/yr - $230K/yr

10+ years exp

Angitia Biopharmaceuticals is a clinical-stage biotechnology company focused on the discovery and development of innovative therapeutics for serious musculoskeletal diseases. The Director of Clinical Quality Assurance will be responsible for ensuring quality and compliance of Angitia sponsored clinical studies and GLP studies, while working closely with various teams to cultivate a culture of quality and compliance across the organization.

Biotechnology

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

Qualification

GCPGLPICHQuality AssuranceBiotechnology experienceAudit experienceClinical studiesComputer skillsProblem-solvingCommunication skillsInterpersonal skills

Required

BS BA (or equivalent) in a relevant scientific discipline

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

Preferred

Advanced degree desirable

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

Company

Angitia Biopharmaceuticals

Angitia is a clinical-stage biotechnology company focused on discovering and developing breakthrough therapeutics that address the key unmet medical needs of serious musculoskeletal diseases.

Founded in 2018

Westlake Village, CA, US

51-200 employees