Quality Manager - Re-Vana Therapeutics
Department: R&D - Quality
Location Belfast, Northern Ireland
Introduction
Re-Vana Therapeutics, founded in 2016 and incorporated in both the U.K. and U.S. is a spin-out
from Queen's University Belfast (QUB) Northern Ireland. We are developing innovative and
proprietary biodegradable sustained-release technologies for the delivery of biologics and small
molecules drugs, with a focus on ophthalmic indications.
Our value proposition is the ability to develop "customized" sustained-release implants capable of
delivering both biologics and small molecules for as long as 6 months or more, thus reducing the
frequency of ocular injections and reducing or eliminating the need for topical eye drops. The
sustained delivery of biologic drugs is recognized as one of the major unmet needs within
ophthalmology. Currently, ophthalmic biologic drugs represent a $14B market worldwide with growth
projections reaching more than $22B by 2024.
Our dual strategy includes the internal development of sustained-release therapeutics alongside the
development of external strategic collaborations with major pharmaceutical partners. To date ReVana has achieved significant progress and global awareness, raising seed money in 2017, a preSeries A in 2020 and a Series A in 2022 that included leading U.S. Ophthalmic and U.K. Venture
Capital Investors. We have been awarded two significant Innovate U.K. government grants for the
development of sustained-release ocular biologics. In 2022, we were awarded the prestigious
Ophthalmic Innovation Summit Retina Award for "Drug Delivery Innovation" and the Belfast
Chamber "Business Innovation" company of the year. In addition, Re-Vana has established a
compelling Scientific Advisory Board (SAB) that includes global ophthalmic opinion leaders.
We are seeking to further strengthen the team by hiring a full-time Quality Manager to develop and
manage a Quality Control system within the company.
The successful candidate will be a key member of the Belfast based team. Reporting to the COO,
he/she will work extensively with the CEO and CTO and the internal scientific team.
This is an outstanding opportunity to help build and contribute significantly to the strategic success of
a well-capitalized, highly innovative startup company within a multibillion dollar market potential.
Brief Description of Role:
Re-Vana is looking for an individual to assume responsibility for the initial management of the Quality
Control/Assurance and Document Controls functions for Re-Vana, as the organization grows these
will become separate well-defined roles. The role will include oversight, identification, development
and maintenance of R&D quality processes including analytical data, documentation, development
and maintenance of internal and in process materials, Finished Goods lot release and stability testing
for in vivo testing, internal and external technology development, evaluation and investigation of
OOS. Act as Quality Control expert providing support for product development and
commercialization of drug/device combination products. Support analytical method
development/validation/transfer.
Responsibilities:
• Develop, implement and own a Quality System including all procedures and processes
• Distribute documentation throughout the organization, on time, to the people who need it
• Oversee testing for raw materials, intermediate materials and final polymer based photo
crosslinked drug delivery products
• Responsible for the identification, selection, qualification, and oversight of analytical laboratories
conducting Quality Control testing, including contract negotiations, future on-site audits and
supplier development activities
• Act as the primary company liaison for Quality Control testing; including communicating testing
priorities, review and approval of OOS investigations, and test method maintenance
• Oversee and own the process for review and approval of analytical data for future GMP testing
of raw materials, in-process materials and finished drug product
• Act as Quality Control during inspections and conferences
with FDA, Notified Body, Competent Authority and other regulatory agencies
• Proactively identify quality related vulnerabilities and champion improvements in
company wide activities
• Facilitate effective communication and collaboration between the R&D team and senior
management
• Maintain current knowledge of federal, state and international regulations and guidance
documents, as applicable (QSR, cGMP, ISO, ICH, etc.)
• Support NCMR, CAPA, Complaint and Internal Audit investigations as needed
• Thoroughly document all issues related to quality control, QSR, cGMP, ICH and ISO compliance
• Support company goals and objectives, policies and procedures
Requirements:
• B.Sc. in Life Sciences, Chemistry, Chemical Engineering
• Minimum 5 years related experience in the pharmaceutical industry supporting GMP testing
activities - start up experience a bonus
• A willingness to work hard, with a driven outlook and with a strong desire to succeed, as a scientist,
as a team, and as a company
• An inventive aptitude balanced with discipline and concern for detail
• Motivated to initiate a new Quality Control system in an academic based, pre-clinical start-up
company
• Experience working on drug/device combination products and / or pharmaceutical development
and manufacturing, from concept through commercialization
• Strong knowledge of domestic and international CGMP, CMC and Analytical regulatory
requirements
• Ability to translate regulations and guidance documents into company procedures and provide
training to cross-functional teams
• Excellent communication and time management skills required
• Strong team player with ability to work with diverse cross functional teams
• Ability to work independently and be able to manage tight timelines and changing priorities
• Working knowledge of statistical techniques (e.g. sample size determination, tolerance intervals,
capability analysis, Regression, ANOVA, DOE) using statistical software packages (e.g. Excel,
Minitab, JMP)
Additional
Remuneration to be based on a fixed salary, bonus and stock options relevant to a startup
organization
Contact
Please send an updated CV with supporting letter to
Michael O'Rourke CEO
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