Director of Quality Assurance

Director of Quality Assurance

Position Summary

The Director of Quality Assurance is responsible for leading a comprehensive range of quality assurance activities in support of Fortvita Biologics’ commercial, clinical, and development programs. This role serves as a strategic and tactical leader in quality initiatives, ensuring compliance with Good Clinical Practice (GCP) standards and overseeing the development, implementation, and continuous improvement of quality systems.

Key responsibilities include conducting GxP audits of both U.S. and international contract/service organizations—including, but not limited to, manufacturing facilities, Contract Research Organizations (CROs), and investigator sites. The Director will lead and coordinate investigations with external vendors and internal teams to address and resolve potential product quality issues.

Additionally, this position oversees the preparation, review, and disposition of internal and external documentation related to GxP activities, ensuring consistency, compliance, and quality throughout the organization’s operations. This role is onsite at the Palo Alto office.

Essential Functions

• Provide quality leadership and oversight for multiple clinical studies across all phases of development (Phase 1 to Phase 3), ensuring activities conducted by Contract Research Organizations (CROs) and other partners comply with FDA, EMA, ICH, and other applicable global regulatory requirements, guidelines, and laws.
• Collaborate closely with Clinical Development teams to plan, organize, and prepare clinically focused regulatory documents for submission to regulatory authorities. Offer strategic input on development plans, including trial design, protocols, and essential clinical development documentation
• Develop, implement, and maintain Quality Assurance (QA) programs, policies, and procedures to ensure compliance with applicable GxP standards:
• cGMP for compliance to clinical trial materials
• GLP for compliance to preclinical studies
• GCP for compliance to clinical trials
• Serve as the primary QA liaison with internal teams, external CROs, vendors, contract facilities, and joint development partners, addressing quality issues related to contracts, validation, change management, and other QA-related matters to support key development milestones
• Lead QA reviews of manufacturing records, clinical trial documentation, and documents submitted to regulatory agencies to ensure accuracy, compliance, and readiness
• Oversee and manage the GxP auditing program and all associated inspection activities, including regulatory inspections and internal/external audits.
• Lead the administration of the company’s Standard Operating Procedures (SOP) system and GxP training program to ensure compliance and continuous improvement
• Ensure the company’s electronic systems and document management platforms are compliant with 21 CFR Part 11, overseeing validation and control of document publishing and management systems in collaboration with IT
• Offer strategic leadership and quality oversight of contractor Quality Systems, including change control, deviations, out-of-specification (OOS) results, and CAPA programs
• Evaluate and resolve deviations in a timely manner, ensuring effective implementation of corrective and preventive actions, and escalating issues when appropriate
• Mentor and guide QA team members at all levels, fostering professional development and providing high-level strategic advice to senior management on complex quality and regulatory matters

Professional Qualifications

Minimum Education

BS/BA in a relevant scientific discipline.

Minimum Experience

• Minimum ten (10) years of related experience in a QA function within the pharmaceutical/biotech industry with knowledge of Quality Systems and Quality Assurance processes, development, implementation and documentation.
• Minimum of eight (8) years of working in a GCP QA function
• Two (2) years of experience at a manager level including supervisory experience of QA personnel.
• SME in GCP guidelines, comprehensive knowledge and familiarity with relevant GxP regulations, ICH, and FDA guidelines critical to clinical development.
• Experience in the clinical trials/drug development process and the Federal law and regulations affecting the pharmaceutical industry.

Other Requirements:

Preferred Education

MS/MA or PhD degree in related discipline; an equivalent combination of education and experience may satisfy the preferred qualifications.

Pref. Certification/Licensure:

• Certification in quality assurance (e.g., Certified Quality Auditor) and/or GCP (e.g., Certified Clinical Research Professional) is desirable

Preferred Experience

• Five (5) years of related experience Quality Systems and Quality Assurance processes, development, and documentation.
• Experience in the biotech or pharmaceutical industry in clinical trials/drug development process and the Federal law and regulations affecting the pharmaceutical industry.
• Five (5) years of experience as a QA Manager including supervisory experience of QA personnel.
• Extensive knowledge and familiarity with relevant GxP regulations, ICH, and FDA guidelines critical to clinical development.

Skills: Other

Aptitude: Required/Preferred

Access data in computer data bases

Answer emails/telephones

Compile data/statistics

Coordinate requests, meetings, and events

Coordinate travel arrangements

Establish, organize, and maintain hardcopy and electronic filing systems

Input data into computer programs

Prepare reports

Proofread documents

Schedule appointments

Use computer programs and software packages

Software

MS Office, required

Veeva Quality Docs, Training and or QMS, required

Electronic/cloud-based documentation and filing systems

Machines/Equipment

Personal computer

Computer peripheral equipment

Working / Environmental Conditions

Subject to interruptions

Subject to varying and unpredictable situations

Manages multiple tasks simultaneously

Handle pressure due to multiple calls and inquiries

Handle pressure due to deadline requirements

Requires judgment that could affect image of Fortvita Biologics

Tobacco-free work environment

Physical Demands

Able to travel by car/air (domestic/international) – Est > 20%

Light physical effort

Mostly sedentary work

Occasional standing/walking

Communication

English languages (verbal, written and speaking ability)

Excellent verbal communication and telephone skills

Excellent written communication skills

Fortvita is proud to be an equal opportunity employer. We are committed to creating an inclusive environment for all employees and applicants and do not discriminate based on any protected characteristic under applicable federal, state, or local law. This includes but not limited to race, color, religion, national origin, ancestry, sex (including pregnancy, childbirth, and breastfeeding), gender identity or expression, sexual orientation, age, marital status, physical or mental disability, medical condition, genetic information, military or veteran status, or hair texture and style. Harassment or discrimination on the basis of any protected trait is strictly prohibited.

We do not accept unsolicited resumes from staffing agencies or search firms. Any resume submitted without a signed agreement will be considered unsolicited, and Fortvita will not be obligated to pay any fees.

Additional Legal Disclaimers

Applicants must have legal authorization to work in the United States. In compliance with federal law, all new hires will be required to verify identity and eligibility to work in the U.S. and complete Form I-9 upon hire.

Employment at Fortvita is at-will. This means that either the employee or the company may terminate the employment relationship at any time, with or without cause or advanced notice. This job description is intended to describe the general nature of the work being performed and does not constitute a contract or guarantee of employment. Fortvita reserves the right to modify job duties or responsibilities at any time, based on business needs.

Reasonable accommodation: If you require reasonable accommodation during the application process, please contact Fortvita’s Human Resources team at hiring@Fortvitabio.com. We are dedicated to ensuring all applicants have equal access and opportunity throughout the recruitment process.