Head of Quality Assurance

Company Profile

Aspyrian Therapeutics Inc., is a privately funded, clinical stage, Biotechnology Company located in San Diego, California. We are focused on advancing innovative science into breakthrough products that provide cancer patients with new treatments to conquer their disease.

Supported by investors that have the commitment to build a long-term company that integrates research, development and commercialization of cutting edge cancer therapies with the aim to transform cancer treatments. Our mission is "CONQUERING Cancer. For LIFE".

Our novel proprietary technology platform utilizes antibodies conjugated with payloads that are specifically activated at the tumor site. Our first clinical product is in mid-stage clinical testing to treat terminal cancer patients. This is a first in class product with unique pharmacological activity and with the potential to have a broad impact in cancer. Given the rapid progression of the clinical studies we are quickly expanding the team to support late stage pivotal clinical development and future commercialization of our products.

Position Summary

The Head of Quality Assurance will be a key member of the Aspyrian team with Global responsibility for establishing and administering all Quality functions related to GXP operations at Aspyrian global offices. The Head of Quality will provide quality oversight and support of Aspyrian's manufacturing, product distribution, clinical operations, and device functions. The position requires domestic and international travel primarily to Aspyrian sites, CRO/CMO locations to conduct audits, and vendor oversight to ensure compliance with cGXPs. The chosen candidate will have strong leadership, communication, and collaboration skills with the ability to prioritize, set goals and meet objectives applying a risk-based compliant approach while working with cross-functional teams. The Head of Quality will be responsible for the compliance of development and commercial stage pharmaceutical products including implementation of quality system programs, GXP US and Ex-US regulations, manufacturing, clinical, and device regulatory inspection preparedness and management, documentation systems, and contract service provider qualification and management.

Major tasks and responsibilities

Establish and administer Aspyrian's Quality Management System (QMS).
Develop and advance the organization's policy and procedures for regulatory affairs and compliance to establish a compliant culture.
Responsible for all quality functions related to clinical, commercial, manufacture and device manufacturing at Aspyrian's CRO/CMO and testing facilities.
Ensure compliance with relevant global quality and regulatory requirements.
Responsible for control of Aspyrian's documentation management and implementation of EQMS.
Up-to-date on current compliance and regulations, standards, and governmental agency activities.
Interprets relevant information and takes appropriate actions to inform and educate stakeholders and revise processes as necessary.
Responsible for Aspyrian's vendor selection, assessment, qualification and management.
Responsible for quality audits and inspections of Aspyrian vendors.
Develop corporate positions on compliance risk-benefit.
Integrate quality compliance considerations into the corporation's global product entry and exit strategy.
Provide strategic input and technical guidance on GXP requirements to corporate and/or management stakeholders.
Responsible for performing release and disposition functions; manage and control cGMP-manufactured intermediates and products.
Heavily involved in lead investigations, risk assessments, and closing out deviations and CAPAs
Responsible for generating a preapproval compliance strategy for Aspyrian's commercial products
Support and provide guidance on late stage process validation activities
Ensure annual licenses, registrations, listings, and patent information are maintained.
Ensure compliance with product post-marketing approval requirements.
Ensure advertising and promotional items are compliant to regulatory requirements.
Review and approve publicly disseminated information.
Review product claims and preserves confidentiality of applicable product information.
Oversee quality aspects of business relationships to ensure compliance and protect corporate interests.
Provide compliance input for follow-up to inspections and audits to minimize potential for findings of noncompliance.
Ensure adverse events are reported to regulatory agencies and internal stakeholders.
Act as liaison between the company and various governmental agencies
Ensures that quality compliance expectations are clear to all internal and external stakeholders (including partners, CROs, consultants, and contractors) in order to execute program objectives in compliance with applicable regulations.
Recruit, develop, and manage the Quality Assurance department as the company's pipeline and development activities grow

Desired Education, Skills and Experience

PhD or MS degree.
Minimum of 15 years of Quality Assurance and drug development experience in the pharmaceutical industry.
Demonstrated knowledge of cGMPs and relevant regulatory guidelines, both in the US, Europe and Japan.
Familiarity with ISO 13485 requirements for the design and manufacture of medical devices.
Experience at all phases of development, including commercialization.
10+ years of experience managing and leading teams.
Thorough knowledge of GXP compliance and FDA regulations.
Experience monitoring costs of projects, as well as human and material resources within a department or unit.
Experience directing and managing the preparation of technical strategic compliance documentation and inspection readiness.
Demonstrated ability to maintain a collaborative relationship across global Aspyrian sites and vendors.
Strong critical thinking, problem-solving, and decision-making skills, as well as dealing with ambiguity.
Excellent oral and written communication skills.
Excellent interpersonal, team building, and motivational skills.
Ability to work independently, analyse, work with attention to detail, and process and prioritize sensitive complex information.
Business travel is typically up to 15% of time, but it may be higher on occasion based on business needs.

We offer a competitive compensation plan with an excellent benefits package including flexible time off, stock options, 401k, medical, dental, vision plans and more.

Aspyrian Therapeutics Inc. is proud to be an Equal Opportunity Employer. We celebrate diversity and are committed to building a team that represents a variety of backgrounds, perspectives and skills.