Vice President, Quality Assurance

JOB TITLE: Vice President, Quality Assurance

DEPARTMENT: Regulatory Affairs

LOCATION: South San Francisco (Onsite/Hybrid/Remote)

TYPE: Full-Time

HI-Bio, Inc. is a clinical-stage biotechnology company based in South San Francisco, California. Our

shared purpose is to transform the lives of patients with severe immune-mediated diseases by developing novel targeted therapies with outsized clinical impact, faster. Our pipeline is strong and built through both in-licensing and discovery. HI-Bio's team is made up of industry experts from science and clinical drug development. We are on a path to building a leading immunology company. To accomplish this, we are seeking top talent to join us on our journey.

The Vice President, Quality Assurance is responsible for overseeing and participating in the phase

appropriate development, implementation and maintenance of quality management practices and systems as governed by GCP, GMP, and GLP (GxP) regulations, to ensure compliance with internal policies, business objectives, procedures, and external regulations and standards. We are seeking a dynamic and seasoned Quality Professional who can bring strategic expertise and strong leadership skills, while also maintaining a hands-on approach to further build the Quality function at HI-Bio. The VP, Quality Assurance will have end-to-end Quality responsibilities inclusive of leading GMP, GCP, and GLP functions. This position will report into the Senior Vice President, Regulatory Affairs, Quality, and Pharmacovigilance.

KEY RESPONSIBILITIES:

• Continues to develop and maintain a phase appropriate Quality Management System (QMS) and oversees its administration.

• Ensures quality and operational regulatory compliance; acts as a subject matter expert for quality investigations, documentation systems, training programs, and internal/external audits.

• In collaboration with cross-functional teams, represent quality with external suppliers; maintains and implements appropriate supplier qualification processes.

• Provide oversight for the qualification process used in the selection and qualification process of clinical, nonclinical, and manufacturing vendors/contractors.

• Participates in the selection, qualification, and oversight of services of local quality consultants and Qualified Person (QPs) in various geographic regions where GXP contracted activities are needed.

• Oversees clinical/pre-clinical program quality audit planning, execution, and resolution of issues.

• Schedules and leads regular Quality Management Reviews on the status of compliance, Quality Metrics, and Quality Standards for facilities, processes, procedures, and practices

• Provides quality oversight of GMP documentation including master batch records, validation protocols and QC test methods.

• Leads regulatory inspections and represents HI-Bio at supplier inspections, as appropriate.

• Handles product complaints, changes, and deviations; leads or supports investigations to resolve quality issues.

• Oversees and implements the execution of GXP and SOP training programs; maintains centralized system for GXP documents including record control, archival, protection and access

• Develops the Quality Assurance operating budget and monitors expenditures

• Identifies GXP and other key compliance requirements and provides leadership in promoting awareness and understanding of global regulatory compliance expectations.

• Leads the Audit Program management process, including assessment of internal and external (outsourced) GXP operations.

• Works with cross functional and other internal project teams to effectively support process and quality enhancement initiatives.

• In collaboration with the CMC group, manages the approval process for raw materials, packaging materials, intermediate and finished products as per the appropriate regulations and site procedures.

• In collaboration with the CMC group, provides quality oversight into the testing program for materials and products, including the stability monitoring programs.

• Partners with senior management to ensure that best practices and proper training are adopted including compliance with all quality policies, quality improvement initiatives and ensuring appropriate quality systems are implemented and maintained.

• Ensures quality data integrity and CDMO manufactured products meet Health Authority regulations and company standards.

EDUCATION AND QUALIFICATIONS

• Bachelor's degree or advanced degree (preferred) in a scientific field

• Minimum of 15+ years quality experience in a biotech/pharma environment with at least 5-7 years as the functional head of quality

• Extensive knowledge of regulatory requirements, quality systems, inspections, audits, and all applicable FDA and EMA regulations and or guidance documents

• Experience in leading and managing regulatory inspections

• Strong working knowledge of GMP/GCP principles

• Hands-on experience with implementing and managing Quality/Compliance systems and processes

• Ability to work in a dynamic, start-up organization with aggressive timelines and multiple deliverables.

• Possesses professional communication skills, strong independent time management skills and the ability to manage multiple projects concurrently in an organized fashion.

• An established history of partnering and managing quality business objectives with CMO/CDMOs

• Experience selecting and overseeing Qualified Persons (QPs) for product quality objectives and product release per geographical requirements

• Able to travel domestically and internationally

HI-BIO RECRUITING:

HI-Bio, Inc. is an equal opportunity employer. We value diversity and do not discriminate on the basis of race, religion, color, national origin, sex, gender, gender expression, sexual orientation, age, marital status, veteran status, or disability status. We are committed to creating an inclusive environment for all employees.

HI-Bio Inc. does not accept unsolicited resumes from any agency that we have not directly engaged on a specific role. Our managers and employees will not accept resumes sent directly from any agency/3rd party. Unsolicited resumes sent to HIBio, Inc. from recruiters do not constitute any type of relationship between the recruiter and/or recruiting agency and HIBio, Inc. and do not obligate HIBio, Inc. to pay fees should we hire from those resumes.