Associate Director Quality Assurance Glp

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 unlock the power of gene therapy to accelerate healthcare transformation. 

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

Primary Duties

The Associate Director (AD) GLPQA will report to the Sr Director GLPQA and will be responsible for developing the GLP Quality Framework. The AD will support all GLP/GCLP activities, provide assurance to the company that GLP studies and clinical sample assays are done in compliance with all applicable regulatory requirements, company policies/ SOPs, and GLP/OECD guidelines.

Responsibilities

Drive the direction, development, implementation and execution of the GLP Quality Framework, and GCLP processes, systems, tools, training, etc.

Liaise and align with other applicable GXP (e.g. GMP, GCP, etc.) Quality Assurance teams to ensure coordination and compliance with overall Spark Quality Systems.

Initiate and drive compliance support of the GLP stakeholders (immunology, translational research, PCO, etc.) and their  activities through GLP/GCLP regulations along with quality process and related consultancy, advice and training.  Will monitor by developing, tracking and reporting compliance metrics.

Create and manage comprehensive GLP Audit Programs. Manage the conduct of GLP/GCLP audits of GLP studies/assays, assays of clinical samples (GCLP), and CROs used by Spark to ensure regulatory compliance.

Serves as the Lead in the coordination, preparation for and management of GLP related inspections by Regulatory Authorities (including pre-inspection activities as well as follow-up activities) Communicates to senior management of critical issues, coordinates the preparation of data trending metrics for reporting into Sr Management.  Interact with GLP/GCLP stakeholders to promote continuous improvement programs through the analysis of these data.

Oversee the maintenance and continued process improvements and operational excellence of GLP Standard Operating Procedures and Policies. 

Train and mentor GLP-QA team members

Manager Third -Party GLP Vendors ensuring appropriate allocation and utilization of contracted GLP resources, globally.

Maintain in depth understanding of business principles, industry dynamics, regulatory environment, market trends, and specific operational details related to GLP/GCLP Quality Assurance activities.

Education and Experience Requirements

• BS in Scientific Discipline/ Life Sciences or related discipline
• Minimum of 10+ years of pharmaceutical industry experience with at least 7 years experience in GLP Quality Assurance with other relevant GXP experience, preferred.
• Experience with OECD regulations.
• Very good knowledge of GLPs, GDPs, quality systems, and GXP auditing required.
• Must have good expertise in GLP regulations, international regulations/guidelines, and have the ability to understand, interpret and apply applicable regulations
• Domestic travel up to 25%

Key Skills, Abilities, and Competencies

• Strong leadership and communication skills with special emphasis on collaboration skills.
• Ability to think strategically and to quickly analyze complex circumstances and problems, and to drive appropriate decisions and actions.
• Very good prioritization, organizational, and communication skills
• Very good written and verbal communication skills in English
• Ability to motivate, develop, and inspire both his/ her team members and cross functional business partners 
• Good computer skills
• Very good interpersonal skills, i.e. ability to build constructive relationships across all levels of the organization, positive & constructive attitude, and ability to work in interdisciplinary teams

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 to $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.