Senior Director of Quality Assurance
Location: Redwood City, CA
- Rezolute is a clinical stage biopharmaceutical company dedicated to advancing therapies for rare, metabolic, and life-threatening diseases.
- In October 2020, Rezolute announced a $41 million private placement which was led by CAM Capital with Federated Hermes Kaufmann, Surveyor Capital and BVF Partners participating, among others.
- Rezolute has initiated a global Phase 2b trial in Europe for their lead asset, RZ358, which is a potential treatment for CHI, a rare pediatric endocrine disorder.
- Rezolute is preparing to initiate a Phase 1 study, for RZ402, in Q1 2021. RZ402 is an IND-ready orally available plasma kallikrein inhibitor for the treatment of diabetic macular edema.
- Earlier this year, Rezolute received a rare pediatric disease designation, for RZ358, enabling eligibility for a priority review voucher.
- More information can be found at rezolutebio.com
The Director of Quality Assurance will ensure independent Quality oversight and conformance with established GMPs in support of a fully externalized CMC platform supplying clinical materials for global trials. Responsibilities include Quality Assurance Operations, Quality Systems, Quality Compliance and Document Control. This Quality leader will act as partner with a small collaborative team of CMC experts to ensure compliance with GMP, GCP, GLP regulations, related Guidelines, and global regulations applicable to the Rezolute product pipeline.
- Provide leadership and accountability for the Quality Assurance function at Rezolute; Authority to approve and/or reject cGMP materials produced for Rezolute
- Mentor Quality professionals reporting to this role
- Apply phase appropriate GMPs for Rezolute cGMP development, manufacturing, and testing
- Responsible for Quality Assurance, Quality Control, Document Control, and GxP Compliance functions in support of formulation, product development and an externalized global CMO / CRO / CLO network
- Negotiate and approve Quality Agreements and related documents
- Provide Quality oversight to ensure product is manufactured, tested, stored and distributed according to cGMPs and other applicable regulations; Approves and/or oversees approval of production batch records, certificates of analysis, specifications, qualifications, investigations, deviations, customer notifications, certificates of origin, and certificates of conformance
- Interact with CMOs and Qualified Persons to ensure timely release of product in ex-US territories
- Perform and/or provide oversight for vendor audits and qualifications
- Maintain appropriate Quality Systems (Supplier Quality Management, Change Management, Document Control, Deviations/CAPA, Batch Record Review, Risk Assessment) suitable for the clinical phase of each program
- Develop, guide, review and/or approve methods, procedures, master records, reports and protocols employed in the conduct of cGMP activities
- Interpret and provide advice to teams regarding Quality guidelines, GxP and ICH regulations, corporate standards and operating procedures
- Proactively ensure compliance with all relevant regulations and guidelines
- Support audit readiness and responses during inspections
- Support Regulatory filings as author, reviewer, or approver
- Bachelor’s Degree in a scientific discipline required; Advanced degree preferred
- The ideal candidate will possess at least 12 years of experience in Quality, Quality Assurance and/or Quality Compliance within the pharmaceutical and/or biotech industry including at least 8 years of experience in management and/or senior leadership roles
- Clear understanding of early and late phase Quality requirements
- Experience with development of small and/or large molecules required, orphan and/or ultra-orphan diseases experience, including primary pediatric indications, is advantageous
- Prior experience building Quality functions, including deployment of EDMS solutions, within a small emerging biopharma company is also an advantage
- Expertise and hands-on knowledge of GMPs, GLPs; Knowledge of GCPs is advantageous
- Ability to multi-task, prioritize options, anticipate challenges, and execute on goals as a member of an interdisciplinary team is extremely important
- Excellent organizational, written, and verbal communications
- Entrepreneurial, innovative, analytical, and solution-minded
- Proficiency in MS-Word, Excel, PowerPoint, and Adobe Acrobat
- Willingness to travel up to 20% (domestic and international)
To Apply: Interested and qualified candidates should send resume to email@example.com, to the attention of Melissa Quinn.