Evergreen Theragnostics, Inc. is a radiopharmaceutical company headquartered in Springfield, NJ. We operate in a brand-new state-of-the-art facility, developing our own radiopharmaceutical products and providing contract development and manufacturing services for other radiopharmaceutical companies. We also operate our own cutting edge cancer research laboratories. The company expects rapid growth in the next few years.
Evergreen is a rapidly expanding team, where all team members support each other in a variety of activities. We are looking for team members who are motivated to take on new challenges and excited to help build the company. Partial equity-based compensation packages possible.
Summary: The Quality Assurance Regulatory Compliance Project Manager will be responsible for ensuring that all projects adhere to regulatory standards, compliance requirements, and quality assurance practices. The role involves managing quality and compliance initiatives, coordinating cross-functional teams, and ensuring that regulatory requirements are met throughout the project lifecycle. The ideal candidate will have a strong background in project management, quality assurance, and regulatory compliance, particularly in industries such as pharmaceuticals, biotechnology, medical devices, or other regulated sectors.
Responsibilities:
Lead and manage quality and regulatory compliance projects from inception through completion.
Develop and maintain project plans, schedules, budgets, and resource allocation.
Ensure project milestones and deliverables are met in a timely manner and within budget.
Collaborate with cross-functional teams (QA, Regulatory Affairs, Operations, R&D) to drive project success.
Ensure FDA inspection readiness for a sterile injectable pharmaceutical manufacturer.
Prepare the facility and QMS for FDA inspection under 21CFR211.
Develop, implement, and maintain quality assurance processes and standards in line with regulatory requirements.
Ensure all project activities comply with industry standards (e.g., FDA, EMA, ISO, ICH, etc.) and regulatory guidelines.
Conduct quality reviews, risk assessments, and compliance audits to identify areas for improvement and ensure ongoing adherence to regulations.
Create and manage corrective action plans (CAPA) for identified non-conformances.
Essential Education and Qualifications:
In-depth knowledge of regulatory requirements and quality systems standards (e.g., FDA, EMA, ISO 13485, GxP).
Ability to work independently and collaboratively in a fast-paced environment.
Previous experience participating in multiple regulatory (FDA) audits.
Proficient in using quality management systems (QMS) and document control software.
Strong communication skills, both written and verbal.
Strong leadership and interpersonal skills with the ability to influence and manage cross-functional teams.
Experience required - in years
Minimum 5-10 years of experience in quality assurance, regulatory compliance, or a related role in pharmaceutical or biopharmaceutical manufacturing.
Education required and/or preferred
Bachelor's degree required in Life Sciences, Chemistry, Pharmacy, or a related field; advanced degree preferred.