Vice President, Quality & Regulatory Affairs

Location
Sarasota, FL, United States
Posted
Feb 23, 2021
Ref
13914101
Required Education
Bachelors Degree
Position Type
Full time
Akron Biotech is continuing to transform and further its rapidly growing capabilities and is now seeking highly motivated professionals to join our expanding team. This is an exciting opportunity to play a critical role within our organization that is driving advanced therapy development and commercialization with high quality industrial scale solutions. We manufacture and distribute components and raw materials for cell therapy discovery, development, and commercialization to meet industry needs worldwide. We offer an array of highly competitive benefits and perks to our valued associates.

This position is specifically responsible for the oversight of Akron Biotech's Quality and Regulatory Affairs activities while ensuring strategies are established in accordance with overall corporate objectives.

General Responsibilities
  • Provide strategic direction and oversight in the preparation of regulatory submissions.
  • Oversee SOP development and other compliance functions in Regulatory Affairs as well as support inspection readiness.
  • Lead cross functional project teams to deliver successful submissions/filings and outcomes for programs by providing expert and effective project management oversight, direction, planning, and execution.
  • Serve as the quality and regulatory affairs expert in development programs via the project team by identifying, driving, tracking and delivering on key milestones/objectives
  • In conjunction with technical departments, acts as primary liaison with outside contractors to coordinate obtaining and completing regulatory documents/data.
  • Lead all regulatory expertise and policy support GMPs; provide regulatory review of SOPs from other departments as necessary.
  • Oversee implementation of QMS and the Quality organization needed to execute it.
  • Serve as the key liaison on Quality matters with all functional departments.
  • Oversee all GMP quality activities and ensures they are governed through key performance metrics and a quality review system.
  • Develops, in conjunction with all stakeholder groups, a Quality Manual and Master Quality Plan for the manufacturing site.
  • Responsible for articulating, leading, and implementing the Quality Manual and Master Quality Plan.
  • Provide leadership on quality policies and practices.
  • Assure that finished Quality projects and work products conform to industry standards and are qualified for regulatory approvals for commercial products.
  • Provide the leadership to assure the preparation of appropriate documentation for filing with regulatory bodies.
  • Provide the overall leadership in respect to recruiting, training, developing and supervising staff to accomplish quality and regulatory compliance goals.
  • Responsible for establishing department budgets and managing expenditures appropriately.

Requirements

  • BS or MS in a scientific discipline.
  • 15 years of biopharmaceutical or biotech experience.
  • Strong knowledge of GMP and FDA requirements.
  • Strong project management and organizational skills with emphasis on attention to detail.
  • Excellent interpersonal and verbal/written communication skills with the ability to build relationships at all levels of the organization.
  • Ability to work independently on multiple projects with tight timelines and minimal supervision
  • A strong experience base on global GMP, QA and QC issues pertaining to biologics is required.
  • Expertise in aseptic manufacturing is required.
  • Knowledge of FDA, EU and International regulations, EU, and US compendial requirements and industry best practices regarding documentation systems, design control, change control, product specifications and cGMP's.
  • Experience in leading cross functional teams, working as a member of such teams, and providing functional resources under supervision to such teams.
  • Strong leader who can achieve agreements through an educational collaborative approach and able to be firm and decisive on quality and regulatory compliance issues.
  • Excellent communication, leadership, collaboration, and interpersonal skills with an ability to serve as a mentor to direct reports.