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