AntriaBio

Vice President, Quality

Vice President, Quality

Location: Remote, Redwood City, CA or Bend, OR

Company Description

Position Summary

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.

Essential Functions

Oversight and Accountability

Qualifications

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.

Other Information

To Apply

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