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Quality Assurance Manager

4 months ago

New Haven, United States Connecticut Innovations Full time

About VeraDermics


VeraDermics is a well-funded medical dermatology company driven to develop innovative therapeutics aimed at transforming the standard of care for a wide range of common skin conditions. Founded by dermatologists, VeraDermics leverages its front-line clinical experience to identify and advance novel drugs that address specific patient needs and solve pervasive treatment challenges in dermatology practice. The company has cultivated a pipeline of diverse, first-in-class, single-molecule therapeutics for highly prevalent dermatologic conditions seen in adults and children. Target indications include common warts, alopecia areata, molluscum contagiosum, and androgenetic alopecia (pattern hair loss). VeraDermics’ lead product candidate, VDMN Patch, offers a new, patient-friendly, injection-free approach for the treatment of common warts. VeraDermics is led by an executive team of board-certified dermatologists supported by a board of directors comprised of recognized biopharmaceutical industry leaders.


Why VeraDermics


  • You Can Be Part of a Meaningful Mission - VeraDermics aims to create a paradigm shift in medical dermatology by bringing pharmaceutical innovation to the treatment of common skin conditions that currently lack meaningful therapeutic advances and have been neglected by traditional pharma.
  • VeraDermics Has Significant Growth Potential – VeraDermics’ Product Candidates Have Cumulative Revenue Estimates of > $6B/Year.
  • VeraDermics’ Has a Proven Track Record – Since our inception in 2019, VeraDermics has advanced its lead asset, VDMN-21, into the most advanced dissolvable microneedle clinical trial ever conducted in the United States
  • VeraDermics is Well Funded – We have raised > $25 million to date. Our investors include J.W. Childs Associates, LP, Vlad Coric, Connecticut Innovations, Werth Ventures, and Northpoint Advisors
  • We have been featured in Forbes, Slate, The Hartford Courant, The Kansas City Star, and many other multi-media platforms.


Quality Assurance Manager


Are you ready to sprint toward patients with us? We’re building our Quality Assurance team, and we’re looking for a Connecticut-based Quality Assurance Manager to help lay the foundation for our function.


This role will play a crucial role in implementing and maintaining our Quality Management System, as well as supporting the regulatory and clinical functions. This role will work very closely with project leaders throughout the product life cycle, including the executive management team. You will perform quality assurance and training to ensure compliance with internal and external regulations and protocol.


We are looking for an established and technically competent professional who independently develops and implements solutions to a variety of quality-related objectives. He/she may lead teams or projects of varying scope and is often called upon by peers for his/her expertise or guidance. Our preferred candidate will demonstrate consistent application of technical knowledge and expertise, execute assignments of medium complexity, and develop solutions for defined problems.


Primary Responsibilities


  • Consults with management to develop and implement solutions for achieving quality related objectives.
  • Conduct quality audits to ensure compliance with FDA regulations and company standards.
  • Collect and analyze data to identify trends and areas for improvement.
  • Collaborate with cross-functional teams to develop and implement quality control processes.
  • Document and report findings, including non-conformities and corrective actions.
  • Prepares, reviews, and in some cases approves SOP revisions, Risk Assessments, Change Control Requests, Incident Tracking System entries and investigation reports.
  • Ensure adherence to quality and regulatory standards (21 CFR Parts) and maintain QMS document control.
  • Assist with supply quality and vendor qualification, including contract manufacturing.
  • Manage regulatory files and collaborate with cross-functional teams for regulatory guidance.
  • Support on validation protocols, and method development, SDS and other documentation for API and Final products.
  • Participate in continuous improvement initiatives to enhance product quality and efficiency.
  • Stay updated on industry regulations and contribute to regulatory strategies.
  • Identify and communicate regulatory risks in product development and commercialization.


Qualifications


  • Bachelor's degree in a relevant field (e.g., Regulatory Affairs, Life Sciences, Pharmacy, or a related discipline).
  • 5-years + of experience in regulatory affairs for medical devices and pharmaceuticals, OTC products, prescription and nonprescription.
  • Must also be familiar with Quality Systems as well as cGMP and other regulatory requirements.
  • Excellent written and verbal communication skills.
  • Attention to detail, strong analytical skills, and problem-solving abilities.
  • Ability to work both independently and collaboratively in a team environment.


Company Culture


VeraDermics is a small and tight-knit operation where our team works tirelessly to develop innovative new therapeutics for dermatology. We hold ourselves to an incredibly high standard and are looking for an exceptional person who is ready to be an integral team member and make a positive impact on the practice of medicine. We strongly appreciate positivity, curiosity, and, above all else, the ability to stay organized and get things done at the highest level and on time. We are incredibly conscious of creating a comfortable, flexible environment that cultivates the desire to be engaged, ask questions, and feel a vested interest in our team's success. Most importantly, you should value honest and direct communication as you recognize that this is the best way for any individual or team to continuously learn and grow. Accomplishing our collective goals will be fun but also complex; you should pursue an ongoing and rewarding challenge


What It's Like To Work With Us


We’re passionate about dermatology and about improving the lives of individuals suffering from common skin conditions. The therapeutics you help us develop will impact the quality of life of millions of people suffering from conditions ranging from common warts to alopecia areata. We believe always striving to do our personal best and to encourage others to be their best. We also believe in treating others with respect and want to create a company that people are excited to work for. Both Cofounders have worked in jobs they dreaded thinking about all Sunday long, we do not want VeraDermics to be that for anyone