Director 0f Quality Assurance (Full Time)
Location: Redwood City, CA or Bend, OR
Rezolute, Inc. is a clinical stage biopharmaceutical company specializing in the development of innovative drug therapies to improve the lives of patients with metabolic and orphan diseases. The company’s pipeline includes four programs comprised of two clinical stage compounds and one late pre-clinical stage platform. Rezolute recently announced a $25M raise with a $45M potential and has opened an office in Redwood City, CA and Bend, OR. We are now seeking highly qualified and dynamic individuals to join and help grow our emerging biopharma company. More information can be found at www.rezolutebio.com
The Director for 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. Working hands-on as part of a small collaborative team of CMC experts, this Quality leader will act as partner, mentor and expert with respect to manufacture and testing in accordance with USFDA GMPs, ICH Guidelines and global governing 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.
- Demonstrate application of phase appropriate GMPs as applied to 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; Negotiates and approves Quality Agreements.
- Provide Quality oversight to ensure product is manufactured, tested, stored and distributed according to cGMPs and other applicable regulations; Approves / delegates approval of production batch records, certificates of analysis, specifications, qualifications, investigations, deviations, customer notifications, certificates of origin, certificates of conformance and Quality Agreements.
- Design and 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; Specifically, design and implement a late phase / commercial Quality System.
- Develop, guide, review and/or approve methods, procedures, master records and protocols employed in the conduct of cGMP activities.
- Interpret, implement, oversee, train, and provide key input to staff on Quality guidelines, GxP and ICH regulations, and corporate standards and operating procedures, and proactively ensure compliance with all relevant regulations and guidelines
- Support audit readiness and responses during inspections
- Support Regulatory filings as author, reviewer or approver
Job Requirements and Candidate Qualifications:
- 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; prior experience in Quality-related roles preferred; demonstrated understanding of late phase Quality requirements.
- Experience in small and/or large molecules for orphan and/or ultra-orphan diseases, including primary pediatric indications, is advantageous
- Building and running Quality functions within an emerging biopharma company is also an advantage, including an understanding of how to leverage the resources of an emerging biopharma company to successfully manage multiple priorities across a diverse therapeutic pipeline.
- Demonstrated experience and abilities that are commensurate with being able to successfully perform the job responsibilities
- Working knowledge of GMPs, GLPs; Knowledge of GCPs is advantageous
- Demonstrated ability to thrive in and positively contribute to a dynamic, lean, flat, and cross-functionally integrated emerging biopharma company in both a strategic and hands-on manner
- Excellent organizational, written, and verbal communications
- Possesses project, time management, and organization skills and the attention to detail required to drive multiple ongoing projects simultaneously
- Entrepreneurial, innovative, analytical, and solution-minded
- Proficiency in MS-Word, Excel, PowerPoint, and Adobe Acrobat
- Willingness to travel up to 20% (domestic and international)
Interested and qualified candidates should send resume to firstname.lastname@example.org, to the attention of Mike Deperro