Associate Director, Quality Assurance Training

Join the Spark Team

We were born of innovation, springing from the curiosity, imagination and dedication of remarkable scientists and healthcare visionaries. Our shared mission is to challenge the inevitability of genetic disease by discovering, developing, and delivering treatments in ways unimaginable – until now.

We don’t follow footsteps. We create the path.

The Associate Director, Quality Assurance Training will report to the Head of Quality Assurance Compliance and will be responsible for establishing and managing training programs for GMP operations.  The QA Training Leader will ensure these training programs are compliant at a minimum with US, EU, Canada, Japan and ICH Guidelines and requirements.   

He/She will be responsible for the overall management of the training program to include ensuring annual GMP training and other industry relevant training is conducted for appropriate personnel.  He/She works with department leaders/heads to develop position-based training. plans, Computer Based Training, for cause training and specific subject matter training, maintains training records for employees (paper and electronic),  is the Administrator of the electronic Learning Management System & ensures that the system remains compliant with regulatory requirements.  Incumbent will interface with Regulatory Authorities during Regulatory inspections & partner audits and is responsible for revising/writing Standard Operating Procedures and Learning Plans that define the Training Program.  

RESPONSIBILITIES

• Develop, implement and manage a standardized and an effective GMP training program to ensure employees are fully aware and current with GMP expectations and requirements and effectively demonstrate this awareness as part of their core competencies.
• Collaborate with external resources and peer departments to analyze needs and develop, implement and measure effectiveness of training.
• Partner with individual department leaders/heads to develop job specific training plans and standard format for curriculum vitae and job descriptions.
• Ensure all Manufacturing, QC, QA, and Facilities employees who operate within GMP guidelines stay up to date with GMP requirements.  Develop and deliver annual GMP, Data Integrity, Inspection Readiness training programs.  Manage training given by outside consultants.
• Create and track Training metrics/reports
• Develop metrics to measure training effectiveness

REQUIREMENTS

• Bachelor’s degree in chemistry, Biology or a related scientific discipline relevant for the industry, or equivalent work experience
• 12 – 15+ years’ experience in the Biotech/Biopharma/Pharma industry with pharmaceutical products intended for human use; working in progressively responsible positions in delivering / designing GMP Training presentations. 
• Extensive knowledge of GMP Regulations including CFR’s, EU, Canada, Japan and ICH Guidelines
• Experience in developing and presenting training documentation / records during Regulatory inspections
• Experience in evaluating, implementing and validating electronic learning management systems

Spark takes into consideration a combination of candidate’s education, training, and experience as well as the position’s scope and complexity, the discretion and latitude required in the role, and external market and internal value when determining a salary for potential new employees.  The base salary range for this position is currently from $139,000-$208,400.

Spark Therapeutics does not accept unsolicited resumes/candidate profiles from any source other than directly from candidates.   Any unsolicited resume/candidate profile submitted through our website or to personal email accounts of employees of Spark Therapeutics are considered property of Spark Therapeutics and are not subject to payment of agency fees.