The Director of Quality Systems at Vibalogics will support the development and implementation of quality systems for the Boxborough, MA facility to ensure compliance with US and international regulations, laws, and guidelines. Reporting to the Head of Quality and Regulatory the Director will be accountable for building and managing quality systems including but not limited to training, documentation, deviation, CAPA, change control, quality metrics, and audits.
This position is responsible for the overall meeting of compliance standards and ensuring that Vibalogics is in full compliance with multi-jurisdictional government-mandated Quality policies and guidelines. The Director of Quality Systems will represent Vibalogics in front of the FDA, EMA, and other health authorities.
Quality Systems specialists, Document control team and External audit team
- Establishing and managing the Quality Management System at Boxborough, MA
- Develop and manage systems for control, handling, and storage of GMP documents
- Identify and initiate improvements to the quality management system, ensuring compliance to all relevant quality standards and regulatory requirements
- Work with clients, external suppliers and contract labs to ensure compliance and quality, including management of audits and quality agreements
- Manage audits by clients, inspections by FDA and other regulatory agencies
Essential job functions
- Manage the implementation and maintenance of electronic QMS systems such as those for
- Document Management, Training, LIMS, etc.
- Provide or support training of all GMP functional areas
- Coordinate and support the creation of and revisions to Standard Operating Procedures (SOPs)
- Collect and report of quality metrics via Quality Management Reviews and the Quality Council
- Promote a Quality Culture
- Interface with Cuxhaven to ensure consistency in Quality Systems
- Build and manage QA Systems staff and processes that will drive innovation, teamwork and efficiency within the organization
- Ensure effective implementation of change control, and corrective and preventive actions to the adhered timelines as appropriate
- Ensures the company is in a constant state of inspection readiness across all functions through continuous education, training and internal audits.
- This role involves travel hat could be up to 25% of the time and may include international travel
- Adaptability and Flexibility – The ability to adapt to working effectively within a variety of situations; adapts to organizational change and to changes in job demands.
- Communication and Teamwork – Ability to effectively express ideas in written and oral context; to work co-operatively with others.
- Relationship Building – Builds productive working relationships across a diverse spectrum of people.
- Organizational Skills – Ability to handle multiple responsibilities simultaneously and still meet high quality and timeliness
- Detail-oriented and highly motivated with excellent written and verbal communication skills required
Knowledge, skills and experience
- BS degree in life sciences, chemistry or minimum of 10 years of experience in Biotech or Pharma and 3+ years’ experience in Quality management roles
- Ability to develop and implement GMP quality systems
- Knowledge of how to identify key quality metrics for maintaining compliance and identifying areas of improvement
- Understanding of domestic and international regulatory requirements
- Ability to effectively prioritize and manage multiple projects and tasks
- Possess a flexible approach to problem solving, be an adept negotiator and apply risk-based decisions
- A team player, who listens effectively and invites response and discussion
- A collaborator who communicates in an open, clear, complete, timely and consistent manner
- Ability to oversee projects to deliver high-quality work product to meet deadlines, cost, and quality goals
- Extensive knowledge of guidelines required by FDA, EMA, and other regulatory bodies
This role is based in Boxborough, MA.
Vibalogics US, Inc. offers a very competitive benefits package including medical, dental, vision, prescription drug coverage, life and disability insurance, 401(k), and generous vacation and time off policies among other attractive benefits. We operate in a world class facility to attract the best and brightest talent to work collaboratively in our mission to bring novel therapies to the patients who need them most.
Vibalogics, Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age status as a qualified individual with a disability, protected veteran status, or any other characteristic protected by law.