Quality Assurance Director, GCP

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Redwood City, CA/Bend, OR/Remote

Company Description
  • Rezolute is a clinical-stage biopharmaceutical company developing novel therapies for diseases caused by chronic glucose imbalance.
  • Rezolute will be initiating a global Phase 3 trial for their lead clinical asset, RZ358, which is a potential treatment for Congenital hyperinsulinism (CHI), 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 2, 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
Position Description

The QA DIRECTOR, Good Clinical Practices (GCP) at Rezolute is a dedicated Quality leader and is responsible for all aspects of Quality Assurance GCP activities to ensure quality assurance and compliance of Rezolute sponsored clinical trials with applicable GCP regulations (e.g., FDA, ex-US, country-specific), ICH GCP guidelines, Rezolute Standard Operating Procedures (SOPs), and current industry standards and practices. The QA DIRECTOR, GCP will establish, maintain, and ensure effectiveness of quality programs and documentation to assure GCP compliance and inspection readiness.

The QA DIRECTOR, GCP is a specific role within the Rezolute’s Quality organization and performs key activities to support Quality Assurance processes specific to the product development plan for Rezolute’s clinical phase programs.  This role is a team partner with Quality Control (QC), Quality Assurance, GMP and Quality Compliance (QComp).  The QA DIRECTOR, GCP provides the quality oversight for all GCP related Contract Research Organizations (CROs), and contract laboratories supporting both clinical and pre-clinical animal studies and will facilitate and drive all product Quality related issues, with support and guidance from the Quality organization.

The QA DIRECTOR, GCP will also serve to collaborate with the Pre-Clinical and Clinical groups to ensure that phase appropriate and proportionate regulatory requirements and guidelines are reflected in their processes. The QA DIRECTOR, GCP will partner with the QA Compliance organization to incorporate key elements in the Rezolute QMS, if applicable.

Principle Duties and Responsibilities Include:
  • Provides GCP oversight and support for clinical operations in ongoing and planned human clinical trials as well as pivotal GLP pre-clinical studies.
  • Work collaboratively with internal Clinical Operations Team to ensure compliance standards are achieved.
  • Develops, guides, and reviews, protocols and reports employed in the conduct of GCP activities
  • In partnership with QA Compliance and Clinical Operations, manage GCP audit program to include routine and non-routine quality assurance audits of clinical vendors, processes, systems, study documents and investigator sites, to ensure integrity and accuracy of study data and assure quality compliance with internal procedures as well as regulatory guidelines
  • Develop and implement detailed audit plans and yearly GCP audit schedules, in coordination with QA Compliance and Clinical Operations.
  • Review and approve Clinical Operations SOPs.
  • Develop and Implement Clinical QA SOPs as they relate to Rezolute’s organization and set-up.
  • Prepare audit agendas and reports and communicate findings with recommendations for corrective action plans.
  • Lead and ensure the timely and effective follow up of all identified or assigned quality issues.
  • Conduct QA oversight of GCP protocols, ICFs, CSRs and other clinical trial specific documents as needed.
  • In coordination with QA Compliance and Clinical Operations, direct or perform CSR audits and eTMF audits as needed.
  • Direct and/or deliver yearly GCP training for internal staff.
  • Work closely with Pre-Clinical, Clinical Operations, and other departments to ensure compliance readiness.
  • Reviews and authors Quality owned sections of regulatory submissions
  • Liaises with other Quality department staff to ensure an aligned, single voice of Quality.
  • Provides technical quality and/or strategic support to clinical vendors and sites during product pre-approval inspections, and routine GCP inspections as required
  • Interprets and applies applicable 21CFR, USP, EP. JP, and ICH regulatory guidelines and directives in conjunction with the Head of Quality
  • Identify and lead cross portfolio Quality initiatives or improvements that will reduce overall risks as required
  • In conjunction with the Head of Quality, translate complex quality concepts and communicate, as appropriate, across the multi-functional product team
Candidate Profile
Qualifications/ Competencies / Requirements:
  • Proven GXP knowledge through experience of working within the clinical development environment with extensive GCP audit experience.
  • Scientific background with demonstrated (ideally ‘hands on’) knowledge of the clinical environment via a drug development role or a regulatory agency inspector role.
  • Recognized as expert with respect to GCP regulations
  • The ability to proactively identify quality concerns and diligently drive toward solutions
  • Highly skilled in the ability to work remotely, with ambiguity and complexity and can continuously modify options and solutions across all levels of the organization.
  • Demonstrated ability to communicate effectively in both oral and written domains.
  • Displays comprehensive knowledge in GCP, demonstrates subject matter level expertise.
  • Ability to execute highly complex, specialized, cross-functional processes and projects.
  • Ability to make significant improvements and changes when required in order to maitain proper Quality Management regardless of  the way the work has traditionally been done,.
  • Works independently and may instruct, advise or coach other professionals.
  • Brings a high degree of technical competency to bare upon their decision making process, applying innovative approaches and methods to more complex problems possessing greater technical complexity.
  • Is fully accountable for the delivery of assigned targets/ objectives in a timely manner.
  • Has the capacity to understand the dynamics around the generation of a progressive teamwork environment. 
  • Has the ability to evaluate current methods and practices in light of industry trends, company capabilities and best practices, and offer creative ideas to enhance performance internally.
  • Systematically analyses information to identify the root cause  and able to follow through the solution to implementation. 
  • Has the capacity to monitor the effectiveness of corrective and preventative measures  for a CRO and is able to identify and evaluate the interface of these improvements with Rezolute’s systems. 
  • Acts as a role model in living the Rezolute values
Preferred Experience, Special Skills and Knowledge:
  • 15+ years of experience with Biotechnology, Pharmaceutical, Medical Device or other, highly regulated, industry
  • Demonstrated Quality Management System experience (GCP specific QMS experience preferred).
  • Demonstrated Issue Management and CAPA experience in a clinical environment.
  • Experience with FDA and other global Regulatory Inspections of Sponsors, laboratories CROs and Investigator Sites.
  • Excellent interpersonal and communications skill
  • Ability to influence diverse stakeholder and drive accountability and decision-making cross-functionally
  • Ability to work effectively with stakeholders, company executives and senior Quality partners.
  • Demonstrated ability to partner with other functional groups to achieve business objectives
  • Results oriented; effectively manages multiple projects and a high workload efficiently
  • Excellent written and verbal skills; ability to communicate effectively with all levels of the organization; effective public speaker
  • Builds strong, effective working teams; builds relationships to share best practices, and collaboratively solve problems
  • In-depth understanding and application of cGxP principles, concepts, practices and standards
Education:
  • BA/BS in life sciences or related field
  • Advanced degree desirable, but not required
  • Other continuing education initiatives or relevant industry or compliance certifications
Other:
  • Ability to travel up to 20% as required

Clinical Trial Manager (CTM)

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Redwood City, CA

Company Description
  • Rezolute is a clinical-stage biopharmaceutical company developing novel therapies for diseases caused by chronic glucose imbalance.
  • Rezolute will be initiating a global Phase 3 trial for their lead clinical asset, RZ358, which is a potential treatment for Congenital hyperinsulinism (CHI), 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 2, 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
Position Description

The Clinical Trial Manager will report to the Director of Clinical Operations and will lead various operational aspects of the clinical management in collaboration with other clinical team members.  Responsible for providing expert and overall support to the clinical study team in matters related to the clinical study documentation, investigational site management and other study related activities, including study start-up, vendor management during the course of the study, interim study management and monitoring as well as trial closeout activities.

Principle Duties and Responsibilities Include:
  • Manage the day-to-day components of clinical trials under the direction of supervisor
  • Ensure assigned deliverables are completed on time, within budget and in compliance with Rezolute SOPs, FDA regulations and ICH/GCP guidelines
  • Prepare and lead team meetings internally and with CROs, CRAs and clinical sites
  • Work closely with relevant functional areas (preclinical development, CMC, regulatory, clinical development, safety and data management) to accurately coordinate and lead clinical study activities
  • Support the identification, evaluation, selection of oversight of clinical trial sites for study conduct
  • Develop RFPs, participate in the capabilities review and selection of CROs and other clinical vendors
  • Develop trial-related training materials for Rezolute/clinical team members and clinical site staff
  • Develop collaborative partnership with study sites and oversee the training of the clinical sites to ensure protocol and regulatory compliance as well as quality and consistency of the data collection
  • Perform on-site monitoring activities as needed and provide monitoring oversight by reviewing monitoring schedules, metrics, and reports
  • Manage clinical vendors (e.g. CRO, central and specialty labs or specialty vendors, IRB, etc.) to ensure timely and quality study deliverables
  • Contribute to the development of key study documents (e.g. protocols, informed consents, case report forms, overall study execution plans, study guides, etc.) and lead system set-up (e.g. UAT of EDC, IRT, Lab Portals, etc.)
  • Accurately update and maintain clinical systems within project timelines, coordinate and plan for availability of clinical and non-clinical supplies required for trial execution
  • Coordinate, review and finalize the content that will be presented for the Investigator Meetings
  • Provide project administrative oversight of the Trial Master File and ensure all study related vendors are contribution to the Trial Master File as required
  • Proactively identify and resolve issues that arise during study conduct with investigators, clinical sites, vendors, and internal teams and know when to escalate
  • Perform clinical data review at the CRF, data listing and report table levels including interim and database lock as well as in preparation of final study reports
  • Assist with invoice review and study budget tracking
  • Provide study progress updates with timelines and metric reports.
  • As we grow mentor and coach Sr. CRAs, CRAs and Clinical Trial Assistants (CTA’s) and continuously foster a team environment
  • Perform other duties and assignments as required for overall success of the projects. Duties may change based on the status of clinical programs and ongoing needs of the organization
Candidate Profile
Qualifications/Requirements:
  • Bachelor’s degree in a relevant scientific discipline or equivalent
  • At least 10 years of experience in managing global clinical trials at all stages of development
  • Strong knowledge of GCP, ICH guidelines and GDPR required
  • Excellent communication skills with a proven ability to work with various clinical sites
  • Demonstrated ability to successfully manage and deliver clinical trials from start-up through close-out including all financial tracking and reporting activities
  • Deep understanding of clinical trial design, protocol development and review
  • Experience with regulatory inspectors and/or inspection-readiness activities
  • Demonstrated successful management of CROs, central labs and other clinical service providers
  • Experience in the management and maintenance of EDC, CTMS and a submission-ready eTMF
  • Strong collaboration and team orientation, with strong written and verbal communication skills
  • Detail and quality oriented with ability to work independently and within a team
  • Self-motivated and able to thrive in a fast-paced, small company environment  
  • Able to solve complex problems, prioritize multiple tasks and plan proactively
  • Experience developing tools and processes that increase measured efficiencies of the company
  • Strong proficiency with MS Word, Excel, Outlook, and PowerPoint
  • Must be willing to travel (25 -30%)
Preferred Experience, Special Skills and Knowledge:
  • Start-up biotech with global experience would be a plus
To Apply

Interested and qualified candidates should send their resume to info@rezolutebio.com to the attention of Human Resources.

Senior Stability Scientist, Quality Control

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Redwood City, CA/Bend, OR/Remote            

Company Description
  • Rezolute is a clinical-stage biopharmaceutical company developing novel therapies for diseases caused by chronic glucose imbalance.
  • Rezolute will be initiating a global Phase 3 trial for their lead clinical asset, RZ358, which is a potential treatment for Congenital hyperinsulinism (CHI), 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 2, 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
Position Description

This is a remote position that is responsible for management of Rezolute’s clinical product stability program. The Senior QC Stability Scientist acts as a liaison between Rezolute and its contract test laboratory (CTL) / CMO partners who manage our physical stability inventory and testing.  The successful candidate will support Rezolute’s objectives by acting as the stability subject matter expert during internal stakeholder collaborations and external team meetings.

Principle Duties and Responsibilities Include:
  • Manage stability program for Rezolute products
    • Plan and execute required studies based on ICH guidance and product strategy
    • Maintain compliant stability documentation, including stability protocols and reports
    • Manage OOS & OOT stability investigations with CMO/CTL partners
    • Ensure timely completion of testing by CMO/CTL partners
    • Expiry assignment: partner with statisticians to support assigned expiry periods / extensions
    • Maintain stability-program related metrics for internal management review
  • Process and interpret stability data using scientific expertise and quality mindset
    • Review stability data for errors and resolve comments in collaboration with CMO/CTL partners
    • Trending: confirm results meet expected trends based on historical data
    • Recognize unexpected results and take appropriate action based on SOPs
    • Determine allowed time out of temperature and support stakeholders when temperature excursions occur
  • Contribute to sound electronic data management practices
    • Key contributor to implement new LIMS system, including developing SOPs and training
    • Enter stability data in a timely manner per established procedures
  • Navigate Quality Systems to maintain compliance
    • Change control: assess changes with respect to stability impact and own relevant CC records
    • Own, author, and revise QC SOPs
  • Regulatory filing support: participate in preparation of regulatory documents (e.g., IND, IMPD, BLA, NDA) including data verification of content
  • Other duties as assigned

Candidate Profile

Qualifications/Requirements:
  • Bachelor’s degree in biology, chemistry, biochemistry, microbiology, or related field
  • 6+ years in pharmaceutical/biopharmaceutical industry
  • 2+ years of GMP stability program management experience
  • Prior use of a LIMS application or electronic database
  • Detailed knowledge of analytical techniques and compendial methods used for stability testing of proteins and small molecules
  • Demonstrated understanding of laboratory investigation methodology for stability OOT and OOS
  • Competent technical writer with expertise in authoring stability protocols and reports
  • Proficiency in GMP analytical data review
  • Prior ownership of change control, deviation, and CAPA records
  • Adept at authoring and revising Standard Operating Procedures
  • Demonstrated knowledge of GMP principles and regulatory guidance, especially ICH stability guidelines
  • Proficient with Microsoft Applications (Word, Excel, Outlook, SharePoint, Teams, etc.)
  • Data-driven mindset with eye for detail
  • Robust problem-solving abilities
  • Capable of maintaining direction while working independently
  • Ability to identify and adapt to changing priorities: determine what matters most
  • Ability to articulate issues to management in a timely manner
  • Self-motivated: ability to interact with a multi-disciplinary remote-based team
  • Effective written and verbal communication skills
Preferred Experience, Special Skills and Knowledge
  • Statistical analysis of QC and/or stability data, including proficiency with statistical software such as JMP
  • Prior implementation of a LIMS application or electronic database
  • Previous partnership with external contract laboratory to coordinate activities between sponsor and service provider
  • Prior author of regulatory submissions, especially stability sections of IND, IMPD, BLA, NDA (S.7, P.8)
  • Previous contribution to annual product quality review (APQR) process, ideally stability reporting
To Apply

Interested and qualified candidates should send their resume to info@rezolutebio.com to the attention of Human Resources.