Director, Global Quality Assurance, GCP/GLP

Director, Global Quality Assurance, GCP/GLP

Waltham, MA

Zenas is a clinical-stage global biopharmaceutical company committed to becoming a leader in the development and commercialization of transformative therapies for patients with autoimmune diseases. Our core business strategy combines our experienced leadership team with a disciplined product candidate acquisition approach to identify, acquire and develop product candidates globally that we believe can provide superior clinical benefits to patients living with autoimmune diseases. Zenas is advancing two late-stage, potential franchise molecules, obexelimab and orelabrutinib. Obexelimab, Zenas' lead product candidate, is a bifunctional monoclonal antibody designed to bind both CD19 and FcγRIIb, which are broadly present across B cell lineage, to inhibit the activity of cells that are implicated in many autoimmune diseases without depleting them. We believe that obexelimab's unique mechanism of action and self-administered, subcutaneous injection regimen may broadly and effectively address the pathogenic role of B cell lineage in chronic autoimmune disease. Orelabrutinib is a potentially best-in-class, highly selective CNS-penetrant, oral, small molecule Bruton's Tyrosine Kinase (BTK) inhibitor with the potential to address compartmentalized inflammation and disease progression in Multiple Sclerosis (MS). Zenas' earlier stage programs include ZB021, a clinical-stage, potentially best-in-class, oral, IL-17AA/AF inhibitor; ZB022, a preclinical, potentially best-in-class, oral, brain-penetrant, TYK2 inhibitor; and ZB014, a preclinical half-life extended anti-CD-19 and FcγRIIb monoclonal antibody.

We are seeking top talent who share our commitment to patients and have a track record of success in acquiring, developing and commercializing products across the globe. Our colleagues have an opportunity to engage in a fast-paced learning environment and experience individual and organizational success as we work towards becoming a global immunology and autoimmune disease leader, while living our values of Transparency, Relationships, Urgency, Excellence and Innovation – TRUE Innovation !

Position Summary:

Reporting to the Sr. Director of Global Quality Assurance, Clinical Development and Operations, the Director of Global Quality Assurance, GCP/GLP is responsible for leading Clinical Quality Assurance (CQA) activities for assigned clinical operations and development programs, including conducting, managing, and overseeing audits, managing quality issues, investigations, and inspections. Additionally, this role is accountable for GCP/ GLP oversight, and for assuring the compliance of studies with our Company's Standard Operating Procedures (SOPs), policies, and all applicable global regulations and guidelines (e.g., United States FDA, European Union Directives, ICH, and National regulations); and will play a key role in process improvement, compliance, and inspection readiness.

Key Responsibilities:

• Conduct oversight activities to determine compliance with internal procedures, Clinical Research Organization (CRO) procedures and regulations by conducting audits/assessments/reviews of key processes clinical trials execution and sponsor oversight processes and providing actionable recommendations to mitigate or eliminate risks and issues identified.
• Support study teams and execute oversight activities, for example, attend study team meetings, collect and perform analysis of study health metrics, review study plans, advise study teams regarding matters of quality and compliance related to issues, risks, investigations, and CAPA's.
• Conduct on-site, hybrid, and/or remote vendor or clinical site audits and or inspection readiness visits.
• Establish, manage, track, and provide status reports for Quality Objectives, and Priorities.
• Serve as the Quality Business Partner (QBP) point of contact for assigned functions.
• Manage ongoing QA for ongoing GCP and GLP day-to-day activities cross-functionally and serve as the quality subject matter expert on applicable regulatory requirements and guidance.
• Provide executive-level reporting of compliance risks, trends, and audit outcomes to senior leadership and governance committees.
• Ensure rapid communication of Quality issues, including potential misconduct, issues of significance with project/product for Health Authorities, business partners and senior management.
• Lead and support health authority inspections (sponsor and sites) and lead inspection readiness activities for assigned studies.
• Collaborate with clinical operations and other functions to develop and refine standard operating procedures (SOPs) related to GCP and GLP.
• Support activities related to key Quality Management System (QMS) programs, including Supplier Quality Management (SQM), audits, and inspection readiness and management.
• Monitors Quality Assurance, Clinical Operations metrics, reporting, and cross-functional review forums, including the Quality Management Review process.
• Stay current with industry trends, regulations, and best practices to ensure the organization remains compliant.
• Interact with third-party vendors and business partners to ensure compliance with Quality standards.
• Build rapport and trust with internal stakeholders in accordance with Zenas values, TRUE Innovation.

Qualifications:

• Bachelor's degree and 10+ years' experience managing Quality activities related to GCP and GLP in Clinical Development and Operations in the Biopharmaceutical industry.
• Extensive knowledge of Quality Assurance principles, practices, and standards.
• GCP and GLP compliance expertise including knowledge of applicable regulatory requirements for US FDA, China, EU, and ICH.
• Comprehensive knowledge of compliance requirements and best practices for building and maintaining the systems, processes, and tools needed for Quality oversight of GCP and GLP activities in Clinical Development and Operations.
• Regulatory agency audit hosting experience.
• Experienced in leading direct reports and managing talent.
• Demonstrated ability to act as both a functional leader and an individual contributor capable of defining and driving work independently.
• Efficacy and efficiency in making and acting on decisions while balancing speed, quality, and risk to deliver value-added business results that meet high-quality requirements with tight deadlines.
• Pushes themself and others to exceed results and helps others to thrive in the face of challenge.
• When an issue arises, directs their time and energy towards resolution.
• Influences functional prioritization decisions to ensure continuous alignment with corporate objectives.
• Regularly leverages strategic relationships and networks both internally and externally.
• Understands the interdependencies between functions throughout the organization
• Embraces and demonstrates a "one team" mindset.
• Enables cooperation across teams or external partners by helping to remove and overcome barriers.
• Flexibility to work non-traditional work hours when needed, given international operations across time zones.
• Ability to travel to and work from the Zenas headquarters monthly and internationally as needed [up to 25%].

#LI-Hybrid

The position is eligible for a competitive compensation and benefits package.

Zenas is committed to fair and equitable compensation practices. The base salary pay range for this role is $166,600 to $208,261. Actual compensation packages will depend on various factors, including, but not limited to depth of experience, education, skillset, overall performance and/or location.

Zenas believes in providing a competitive compensation and benefits package to all employees. Our base salary is just one component of Zenas' competitive total rewards strategy that also includes annual performance bonus, equity, full range of benefits and other incentive compensation plans.

Zenas BioPharma is proud to be an equal opportunity employer. We are committed to fostering an environment where diversity is valued. All qualified applicants will receive consideration for employment based on merit, qualifications and the needs of the business.