Director, Global Quality Assurance, (Medical Devices/Combination Products)

Zenas BioPharma is a global biopharmaceutical company committed to becoming a leader in the development and commercialization of immune-based therapies for patients around the world. With clinical development and operations globally, Zenas is advancing a deep and balanced global portfolio of potential first- and best-in-class autoimmune therapeutics in areas of high unmet medical need while meeting the value requirements of the dynamic global healthcare environment. The company’s pipeline continues to grow through our successful business development strategy. Our experienced leadership team and network of business partners drive operational excellence to deliver potentially transformative therapies to improve the lives of those living with autoimmune and rare diseases.

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

This Global Quality Assurance role provides quality leadership and oversight of medical device and combination products development and management at Zenas BioPharma. This position reports to the Senior Director of Global Quality Assurance, Technical Operations and works closely with the members of Technical Operations, Regulatory, Clinical Trial Material Management, and Commercial Teams; as well as external stakeholders and suppliers.

Key Responsibilities

• Serve as the quality and compliance lead and subject matter expert for all internal and external activities related to the development and commercialization of medical devices and combination products.
• Lead quality aspects of relevant elements of the quality management system (deviations, change control, CAPA, complaints, risks assessments, procedure development, implementation, and inspection readiness) and quality aspects of the combination product development and management.
• Develop and maintain the quality strategy to provide quality guidance to Technical Operations team during all phases of design control, risk management, human factor engineering, process development, verification/validation testing, packaging, and distribution, as well as lifecycle management of design changes and documentation.
• Monitor and ensure internal stakeholders’ decision-making and actions are consistent with cGMPs, QSR (FDA 21 CFR Part 820), ISO 13485, Good Distribution Practices (GDP), relevant internal laws and guidance’s, and Zenas policies and procedures.
• Ensure compliance of the electronic Design History File (DHF) and Device Master File (DMF), and relevant combination product elements of the QMS.
• Maintain and support continuous improvement to the combination product QMS, monitor and identify areas for improvement and ensure remediation.
• Author and implement Quality procedures, and training related to medical devices and combination products.
• Prepare and present to Management periodic reports and status of compliance of medical device and combination product development and preparation for commercialization
• Provide GMP guidance to CDMOs and Zenas Technical Operations manufacturing teams on the floor (Person-in-Plant).
• Meet with Quality, Production, Regulatory, and Logistics personnel at the CDMO sites as necessary or during regularly scheduled meetings for issues relating to Zenas products.
• Provide Zenas Quality support of CDMO site activities (e.g., NPI, tech transfer, PPQ, filings, etc.) site in accordance with the Quality Agreement
• Conduct reviews and approvals (pre- and post-execution) of FDP Master Batch Records (MBRs) and any associated supporting documentation, (such as stability and validation documentation, generation/updating of compliance dossiers etc.), to support lot disposition and prior to final assessment by a Qualified Person (QP).
• Serve as the main Quality contact for deviations and out-of-specification (OOS) results; initiate CAPA processes and investigate the root cause and ensure timely closure of CAPA; ensure all deviation, OOS result, and CAPA records are accurate, complete, and auditable; and compile and analyze the deviation, OOS, and CAPA data for future improvement.
• Ensure rapid communication of Quality issues, including issues of significant deviations with project/products, to business partners and senior management.
• Identify compliance gaps and improvement opportunities to inform the corporate Quality Plan and/or Inspection Readiness plans.
• Manage inspection-readiness activities and inspections from global Health Authority agencies or third parties.
• Support global Health Authority inspections, submissions, and dossier approvals.
• Support and perform internal and external CDMO quality audits.
• Develop and maintain Quality Technical Agreements.
• Attend routine business meetings and operating/management reviews as the quality representative.
  
  

Qualifications

• Minimum of Bachelors’ degree in relevant scientific or engineering discipline, and at least 15 years of relevant experience.
• Extensive knowledge of FDA regulations (21 CFR Part 820, 21 CFR Parts 210/211), ISO 13485, and other relevant medical devices international standards
• GxP compliance expertise including knowledge of applicable regulatory requirements for US FDA, China, EU, and ICH.
• Experience in engaging with global Health
• Experience leading QMS implementation, maintenance, and improvement initiatives, including authoring procedures, including CAPA, change control, and risk management processes.
• Demonstrated ability to function 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.
• Flexibility to work non-traditional work hours when needed, given international operations across time zones. Able to successfully manage workload and timelines.
• Familiarity with basic project management tools; strong project management and problem-solving skills.
• Excellent interpersonal, verbal, and written communication skills.
• Ability to travel to and work from the Zenas headquarters monthly and internationally, as needed [up to 40%].
• Located in the northeast region of the United States to enable routine presence at CDMO in Allentown, Pennsylvania, and face to face interactions with CDMO’s located in New York and Massachusetts.
• Relevant professional certification.
  
  

Zenas is committed to fair and equitable compensation practices. The base salary pay range for this role is $175,000 to $225,000. 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.