Vice President, Quality
Location: Remote, Redwood City, CA or Bend, OR
- Rezolute is a clinical-stage biopharmaceutical company developing novel therapies for diseases caused by chronic glucose imbalance.
- Rezolute has initiated a global Phase 2b trial in Europe for their lead clinical asset, RZ358, which is a potential treatment for Congenital hyperinsulinism (Congenital HI), an ultra-rare pediatric genetic disorder characterized by excessive production of insulin by the pancreas.
- The company’s second clinical-stage asset, currently in Phase 1, RZ402, is a selective and potent plasma kallikrein inhibitor (PKI) being developed as a potential oral therapy for the chronic treatment of diabetic macular edema (DME)
- Rezolute has received orphan drug designation in the United States and European Union as well as a rare pediatric disease designation, for RZ358, enabling eligibility for a priority review voucher.
- More information can be found at rezolutebio.com
Rezolute is seeking to attract a key member of its leadership team to be the Vice President of Quality, with the mandate to provide the vision, leadership, strategy, and management skills to oversee, lead and further expand the company’s proprietary programs through preclinical, clinical and commercial stages. In particular, the VP of Quality will act as the product release authority for Rezolute, drawing on the fundamentals of Patient Safety, Product Quality, Risk Based Assessment, and robust Quality Assurance and Control systems. Practically, the VP of Quality will have oversight and accountability over Quality Operations, Quality Control, Document Control and quality systems. In conjunction with the Head of CMC, the VP of Quality will have oversight of all GLP and GMP activities performed by Contract Development and Manufacturing Organizations and Contract Testing Laboratories supporting Rezolute.
This role is a key member of the company Senior Management Team and will be responsible for establishing the vision for Quality at Rezolute. The Vice President will identify strategic Quality issues and present risk and impact analysis to Senior Management in a constructive, clear and actionable manner using metrics and data. The initial priority will be re-establishment of a culture of Quality at Rezolute, and through this a fingerprint throughout all applicable operations, by alignment, relationship building and mentorship. Fundamental to this will be design and implementation of a phase-appropriate Quality System. Once established the VP of Quality will shepherd and mature these systems, the Quality organization and the corporate Quality culture as Rezolute progresses on its journey to become a commercial enterprise.
The Quality organization provides oversight of all external CDMO, Contract Test Laboratories and critical starting material manufacturer activities, and ownership of the Vendor Qualification System. Daily, Quality provides leadership in the tactical execution of development programs including but not limited to tech transfers between sites and CDMOs, program specific development and GMP operations, supporting major/critical investigations, authoring or approval of related regulatory filings, and supporting inspections. Quality is also accountable for providing support for clinical operations in ongoing and planned human clinical trials as well as pivotal GLP pre-clinical studies. This position will also be responsible for adapting and advancing internal quality standards (quality policy, quality manual, quality systems, vendor audit reports, site master file, master plans, etc.) as well as review and approval of applicable standard operating procedures (SOP’s), change control documents, production batch records, specifications, batch release documents, etc. This includes responsibility to ensure all operational related activities at the CROs, CDMOs and CTLs are conducted to achieve cGxP compliance in concert with Rezolute’s business objectives. In addition, they will be a key member of several cross-functional teams where collectively they will provide direction and recommendations across clinical operations, cGMP manufacturing, testing and other essential GxP activities.
- Participates as a core member of the Management Team providing Quality expertise, representation and oversight.
- Creates, collaborates, leads, and enforces a culture of Quality throughout the company to help ensure compliance with all applicable regulations, corporate standards, policies, and procedures consistent with Rezolute’s values: Honesty, Open-mindedness, Nimbleness, Open and Transparent Communication and Respect (HONOR).
- Establishes strategic goals for Quality, aligning with the Head of CMC and Clinical Operations, playing an active voice in communicating these throughout the company in a spirit of shared partnership, motivating others through personal leadership and credibility
- Develops phase appropriate Quality operating models in accordance with ICH risk-based compliance guidance; set a strong foundation for future commercial operations.
- Provides leadership, mentoring, and coaching for the members of the Quality team; supporting their career development in line with the business needs
- Identifies critical compliance and/or business issues related to cGxP CDMOs, CROs, Contract Test Laboratories and manufacturers of critical starting materials. Creates and executes remediation strategies and tactical plans as needed using a risk management-based approach.
- Collaborates with External Partner Quality organizations at CROs, CMOs, Contract Laboratories, and critical starting materials manufacturers to ensure uninterrupted supply ensuring full support to current and future production plans.
- Drives major/critical deviation investigations to ensure minimal risk to product quality, efficacy, and safety.
- Manages the development and reporting of Quality metrics and periodic reporting describing compliance trends and any areas of risk with associated mitigation plans
- Ensures that the company, its contractors, and vendors are prepared for FDA and Health Authority inspections and hosts these inspections where appropriate
- Supports the inspection readiness program in at CDMOs, Contract Test Laboratories, critical starting materials, and suppliers and coordinates responses needed for External Quality topics.
Oversight and Accountability
- Oversees, manages, and provides development opportunities for staff and technical leaders in all areas of Quality.
- Accountable for implementing the Rezolute executive strategy by clearly defining deliverables in the context of the corporate plan for each functional area and then measuring the results against the goals. This includes listening to and gathering any concerns, finding common ground solutions, highlighting necessary changes, and then collaborating with the executive committee to endorse changes in the strategic plan, where necessary.
- Assesses Quality resource requirements against current and planned organization and ensures key gaps are identified and resolved. Develops and manages departmental budgets.
- Works with technical leaders to develop policies, processes and programs that ensure efficient workflow and the production of high-quality drug product and associated documentation. Ensures development processes comply with regulatory requirements to minimize risk to the organization, and addresses the analysis and evaluation of process development procedures and practices to ensure compliance with regulatory, legal and good manufacturing procedures to attain corporate goals.
- Ensures clinical trials are managed in compliance with global regulations; Augments staff / external resource to adequately address GCP
- Work collaboratively with Regulatory Affairs colleagues to manage, direct and monitor the preparation, assembly and filing of Regulatory submissions to support clinical trial applications and new product marketing applications, including interactions between the company and health authority representatives to facilitate IND, IMPD, NDA, MA, BLA and other submissions. Directly accountable at the executive level for the accuracy and quality of all associated documentation, including submissions and query responses provided to regulatory authorities. Ensure compliance with respect to GxP requirements to assure favorable compliance reviews and audits.
- Build, lead, manage and develop a best-in-class, high-performance team and related support functions. Provide effective leadership to the organization to ensure the development of the business and its people. Manage the organization to accommodate anticipated growth and to ensure technical strength across all levels. Ensure technical leadership and all departmental associates have development opportunities and plans for career advancement, are provided with routine and useful feedback, have personal goals aligned with corporate, program team, and brand goals and a clear understanding of how their work directly impacts patients and is relevant to the success of Rezolute.
- As a part of the management team, participate in strategic and operational decisions growth of the company.
- Ensure appropriate Quality oversight of external CDMOs, CTLs, CROs and internal resources to ensure effective production to supply clinical studies in compliance with Global Health Authority Regulations as well as regional requirements and ICH Guidelines.
- Routinely assess and define risks associated with in the span of control, create and implement effective mitigation plans, and escalate as appropriate.
- Ensure the organization’s resources are aligned and prepared to support the development, launch, and clinical manufacturing needs for quality production
- Work collaboratively with Clinical, CMC and Regulatory to oversee establishment of development stage and product appropriate specifications aligned with production capabilities.
- Ensure all Quality agreements are effectively negotiated to meet the near- and long-term needs of Rezolute in a cost-efficient manner as agreed with legal, finance and functional heads.
- Develop departmental budget and product cost structure and identify cost improvement opportunities. Have full budget responsibility and accountability. Review and approve departmental expense and capital budgets.
Education & Experience:
The successful candidate will have a strong record of accomplishments and leadership experience in biologics and/or small molecule drug development and commercial drug product manufacturing, preferably with experience in a biotechnology company that has scaled from early-stage product development to commercial or near commercial-stage. They should have a track record of establishing a global commercial Quality organization and have had successful interactions with the Health Authorities, as demonstrated by timely global submissions, approvals and clinical and commercial supply of pharmaceutical compounds, specifically biologics drugs.
- Bachelor’s degree, MS, or PhD in Regulatory, Medical, Physical or Natural Sciences and 12-15 years of experience with a minimum of 8 -12 years' experience in Quality Operations and/or external Manufacturing management, or equivalent levels of education and / or experience.
- Biologics (monoclonal antibody) and aseptic manufacturing experience is preferred.
- Minimum of 7 years of Sr. Management experience; confidence in organizing, messaging and presenting from the “shop floor” to Executive Management / Board of Director.
- Experience building or significantly developing a Quality organization with Department budget management accountability
- Experience working with US and EU CMOs and global clinical sites
- Comprehensive knowledge of FDA and EMA regulations and experience in interaction with US and international Health Authority inspections.
- Experience in hosting FDA and other Health Authority inspections and driving timely responses.
- Experience working in or liaison with a Contract Manufacturing Organization
- Experience in tech transfer of processes and/or facility set-up and design
- Experience and success in an entrepreneurial, dynamic, complex, and fast-paced team environment; enjoys working with cross-functional teams to jointly solve problems in a pragmatic manner
- Experience in identifying compliance gaps, writing, evaluating, and closing investigations with strong technical writing experience.
- A working knowledge of cleanrooms, aseptic technique and hygienic requirements of sterile products
- Understanding of biotechnology-based QC techniques applicable for in process and final release testing of monoclonal antibody drug products
- Experience with equipment, process, method qualification/validation
- Excellent people leader with strong coaching and mentoring skills
- Ability to synthesize data and summarize outcomes to provide recommendations on a compliant path forward.
- A leader who is self-reflective and leads by example and drives the organization’s performance with an attitude of continuous improvement by being open to feedback and self-improvement
- Well organized – a natural ability to be organized in how you think, communicate and conduct your work
- Position may require occasional evening and/or weekend commitment
- The position is remote however, may be in either our Bay Area or Bend, OR offices. Position may require domestic and international travel (between 20% to 40%)
Interested and qualified candidates should send their resume to firstname.lastname@example.org to the attention of Melissa Quinn.