There is a life sciences revolution occurring being driven by the tremendous demand for cell and gene therapies. This demand coupled with the desire for collaboration, the availability of capital, regulatory mind shifts, technological developments, and bottlenecks in supply chains are creating tremendous opportunities for first movers and service providers. The Discovery Labs platform supports and drives this new environment by creating space for CGT Manufacturing, Research and Discovery and the all supporting services.
Are you looking for a company driven by innovation and passion for saving lives that will inspire you and empower you to challenge yourself every day? At The Center for Breakthrough Medicines we are building an unprecedented enterprise that brings together all of the necessary capabilities, infrastructure, and world class leaders to facilitate the development and manufacturing of cell and gene therapies from bench to bedside. Join us as the Vice President of Quality Assurance and Regulatory Affairs at our King of Prussia, PA flagship campus. The Discovery Labs Center for Breakthrough Medicines aims to be the leading global provider of world-class cGMP manufacturing, turnkey laboratory solutions, critical materials and office space that support therapeutic products and services to the biotechnology and pharmaceutical industry. Our mission is to help accelerate the delivery and affordability of life changing therapies to the they so desperately need through seamless access to the development and manufacturing capabilities required to launch innovative cell and gene therapies. Our gene therapy resources, and manufacturing technologies address the full spectrum of service needs from early stage innovation through commercial launch.
We are seeking a proven industry leader with a well-rounded and proficient understanding of the Global Regulatory needs of the worlds most advanced therapeutics/biologics to become our Vice President of Quality Assurance and Regulatory Affairs. It is a very exciting time to join our fast-growing Cell and Gene Therapy Contract Development Manufacturing Organization (CDMO), and we are seeking individuals who think BOLDLY and THRIVE in an entrepreneurial setting. With the help of our Executive team, Senior Management, experienced staff and team members we will partner with some of the most cutting-edge biotechnology companies to help develop, manufacture and commercialize the world’s next-generation therapies.
The Vice President of Quality Assurance and Regulatory Affairs will report to the Chief Executive Officer and will be tasked with creating the vision for and designing the long-term Global Regulatory Affairs (GRA) and Quality Assurance (QA) strategy for the company. The role will be responsible for building and leading a world-class organization, driving cross-functional collaboration, and ensuring the highest level of compliance and quality in the industry. The Vice President of Quality Assurance and Regulatory Affairs will serve as the main point-of-contact for US and international health authorities and will play an essential role to the overall success of the company and our partners/clients therapeutics. As Vice President of Quality Assurance and Regulatory Affairs you will be empowered to build your team, deliver at a high level and be a vital contributor to the Executive team in our mission to cure disease through next generation cell and gene therapies.
- Function as the primary contact to regulatory agencies in key approaches and work with the functional and core teams to develop novel cell and gene therapies that safely, thoroughly and accurately accelerate our clients pathway to biological licensure.
- Oversight and accountability for the successful planning, organizing, and conduct of formal meetings with regulatory agencies including advisory committee meetings, oral explanations and other scientific and development meetings.
- Partner with CMC/manufacturing, clinical, commercial and legal functions in the development and execution of strategies designed with the client’s technology and products.
- Manage and lead the preparation of clients/ partners pre-IND, CMC and BLD documentation and submissions for both the FDA and EMEA; leading all aspects of regulatory functions and ultimately building out a regulatory affairs team as the company grows from start up to a mature global platform.
- Drive the development of, and adherence to, standard operating procedures (SOPs) and working practices in compliance with good laboratory, clinical, and manufacturing practices (GXP) with a particular focus on current Good Manufacturing Practices (cGMP).
- Provide strategic guidance to all clients regarding advanced therapies drug development and all aspects of regulatory requirements, bringing products to the clinic, through regulatory approval, and to commercialization.
- Create and implement trainings and interpretations of FDA and other regulatory agencies guidelines and compliance issues across the organization.
- Assure compliance with project team timelines and milestones for global regulatory deliverables.
- Deep knowledge of FDA and ICH regulations, industry standards, CMC guidelines, DMF oversight and other policies applicable to the design and analysis of clinical trials intended for regulatory approval.
- Keeps current with relevant regulatory, scientific and medical literature and guidelines in support of innovative, efficient and productive clinical-regulatory strategies for optimizing development and productivity of product pipeline
- Strong understanding of the drug development process, government policies, code of federal regulations, cGMP, and GXP specifically in Cell and Gene Therapies.
- Successful track record of working in a matrix organization while building strong partnerships with other organizations including R&D, Manufacturing and Senior Management Team.
- Experience operating in a multi-disciplinary drug development environment including international experience and exposure to a variety of therapeutic areas.
- Knowledge of applicable HHS and FDA standards for adequate provisions to protect the privacy of subjects and to maintain confidentiality of data
- Extensive experience in cGMP and other Regulatory compliance requirements (GLP, GCP, CMC, preclinical).
- Experience with global regulatory interactions and affairs including USA, EU, and JAPAC.
- Visionary and forward thinking with the ability to influence and effectively drive organizational change and continuous innovation
- Ability to work in a global ecosystem (internal and external) with a high degree of complexity
- Ability to take calculated risks implementing innovative solutions, accelerating time to market
- Ability to seek diverse input from multiple constituents and stakeholders to drive innovative solutions
- Ability to incorporate feedback and ensure decisions are made swiftly to yield flawless results
- Advanced scientific degree (PhD) highly preferred
- 10-15 years in the pharmaceutical / bio manufacturing industry
- 5-10 years of direct management experience leading regulatory responsibilities in a commercial organization.