Executive Director, Head of Quality

Job Title: Executive Director, Head of Quality, Radiopharmaceutical Manufacturing

Location: Indianapolis, IN

ID#: R10

Background

RayzeBio is a dynamic biotechnology company headquartered in San Diego, CA. Launched in late 2020 and recently acquired by Bristol Myers Squibb (BMS) as a wholly owned subsidiary, the company is focused on improving survival of people with cancer by harnessing the power of targeted radioisotopes. RayzeBio will operate as a standalone entity within the BMS organization, maintaining its biotech culture with the opportunity to leverage the best-in-class oncology capabilities of BMS. RayzeBio is developing innovative drugs against targets of solid tumors. The lead asset, RYZ101, is in Phase 3 testing for patients with gastroenteropancreatic neuroendocrine tumors (GEP-NETs), as well as earlier stage testing for patients with small cell lung cancer (SCLC) and breast cancer. Led by a successful and experienced entrepreneurial team, RayzeBio aims to be the global leader in radiopharmaceuticals.

Summary

RayzeBio is seeking a Head of Quality at our state of the art Radiopharmaceutical Manufacturing Facility in Indianapolis, IN (USA). This role will be responsible for leading the day-to-day Quality operations and driving commercialization efforts for current and future clinical programsOversight of the entire Quality organization including Quality Assurance Operations, and Quality Systems and Compliance with oversight over Quality Control and CMC as well as Clinical Quality of clinical trials.

The role will also be a key strategic contributor to the implementation, execution, and optimization of quality systems in support of manufacturing, testing and release of commercialized radiopharmaceutical products. This includes but not limited to the implementation of policies, practices, procedures, standards, and systems necessary to ensure the compliance of site operations to global GMP regulations.

The role is also responsible for the operational improvement within the Site Quality team of product quality, GMP compliance, supply chain delivery time, and process efficiency through application of operational excellence, risk management, and knowledge transfer principles.

This individual will be a key leader in the Quality organization and a champion for quality principles and compliance within the Indy Radiopharmaceutical Manufacturing Facility organization. This individual will be a member of the Manufacturing Leadership Team in Indy in addition to the Radiopharmaceutical Development Strategy Teams. This role is stationed in Indianapolis, IN and reports to the Senior Vice President, Drug Development and Operations for RayzeBio based in San Diego, CA.

Job Responsibilities

Essential duties and responsibilities include the following. Other duties may be assigned.

• Responsible for the Quality oversight of GMP operations at the Radiopharmacetuical manufacturing facility, and ensuring adherence to applicable GMP regulations and company policies and procedures

• Assure the required processes, procedures, systems and resources are in place to ensure compliant and efficient disposition of materials and products

• Collaborate with other leaders across the organization and assist in the continuous improvement and lifecycle management of GMP policies and quality management system

• Provide leadership and build an exceptional team to manage the Quality functions (Quality Assurance, Quality Systems, Quality Control), including hiring, mentoring and developing personnel

• Work collaboratively with Leads from Facilities and Engineering, Manufacturing, IT, Clinical Operations, Logistics, and MS&T, to ensure the ongoing qualified and operational readiness for commercial manufacturing at the facility

• Lead the management review of quality compliance and operational KPIs at the manufacturing facility; ensure timely mitigation of unfavorable trends

• Lead the implementation of site readiness for FDA Pre-Approval Inspection Pre-license inspection

• Provide expertise and guidance in interpreting governmental regulations, agency guidelines and internal procedures to assure continued compliance at the facility

• Lead and host compliance audits and regulatory inspections by competent regulatory authority (e.g., FDA, EMA, PMDA, etc.)

• Develop departmental goals and ensure timely completion of all deliverables

• Champion and foster a positive and quality compliance culture

• Establish and effectively manage the Quality annual operating budget

• Represent and lead Quality in the development of corporate initiatives and planning

Education and Experience

• BS/MS in relevant Science or Engineering discipline and 15+ years of experience in managing Quality functions

• Expertise in GMP compliance and global, local and US/EU regulations required, experience in GCP compliance and clinical trial execution preferred

• Experience in hosting global regulatory agency inspections including pre-approval inspections (PAIs) and successfully presenting product and quality compliance programs to regulatory agency reviewers is required

• Experience with implementing and overseeing GMP operations in a commercial manufacturing facility is required

• Demonstrated Quality leadership through a partnership approach with manufacturing to enable high quality and compliant product distribution to patients is required

• Background in aseptic manufacturing for intravenous product is required

• Demonstrated experience building and leading exceptional Quality Assurance, Quality Systems and Quality Control teams is required

• Experience in continuous improvement, operational excellence and six-sigma is desired

• Demonstrated excellence in written and verbal communication

• Demonstrated ability to work cross-functionally and to develop and maintain strong business partner relationships

• Proven leadership ability to carry out difficult decisions in a logical, rational manner, and demonstrated ability to work as a senior management team member and to engage and influence team members in a matrixed environment

Skills and Qualifications

Beyond having the requisite experience and qualifications, a successful candidate will have high levels of self-motivation, adaptability, critical thinking, analysis, and creative problem-solving. This is a fast-paced position within a fast-paced organization, so the ability to come in and hit the ground running is critical for success in the role.

The starting pay rate takes into account characteristics of the job, such as required skills and where the job is performed.

Final, individual compensation will be decided based on demonstrated experience.

Benefit offerings are subject to the terms and conditions of the applicable plans then in effect and may include the following: Medical, pharmacy, dental and vision care. Employee assistance programs (EAP) and a 401(K). Financial protection benefits such as short- and long-term disability, life insurance and supplemental health insurance. Work-life programs include paid national holidays and optional holidays, Global Shutdown days between Christmas and New Year’s holiday, up to 120 hours of paid vacation, and sick time off. Parental, caregiver, bereavement, and military leave. Other perks like tuition reimbursement.