Location: Philadelphia, PA
Company: Spark Therapeutics
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 medical 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.
Quality Assurance (QA) jobs involve ensuring that products, services, or software meet established standards of quality before they reach the consumer. Professionals in QA roles are responsible for identifying defects, implementing test strategies, and ensuring compliance with industry regulations. Key features of QA jobs include attention to detail, a systematic approach to problem-solving, and a focus on continuous improvement. QA specialists work to prevent errors and enhance customer satisfaction by aiming for zero defects and delivering reliable performance.
Quality Assurance (QA) jobs involve ensuring that products and services meet certain standards of quality before they reach the consumer. Those in QA roles are responsible for developing and implementing testing processes, inspecting products for defects and non-compliance, and analyzing quality data to drive improvements. A key characteristic of QA positions is the focus on preventing errors rather than just correcting them, which necessitates a proactive approach and attention to detail. Additionally, QA professionals often collaborate closely with production teams to foster a culture of quality throughout an organization.
Quality Assurance (QA) jobs involve the systematic monitoring and evaluation of the various aspects of a project, service, or facility to ensure that standards of quality are being met. The primary goal is to identify defects and issues before the product reaches the customer, thereby ensuring customer satisfaction and maintaining the reputation of an organization. QA roles often require attention to detail, strong problem-solving skills, and a good understanding of industry-specific regulations and standards. These jobs can vary widely, from software testing to food safety inspection, but they universally function as a critical checkpoint in the production and delivery process of goods or services.
Quality Assurance (QA) jobs involve ensuring that products, services, or processes meet established standards of quality through systematic activities and measures. These roles typically focus on preventing defects, identifying potential issues, and implementing solutions to maintain quality consistency. Key features of QA positions include rigorous testing, meticulous attention to detail, and a commitment to continuous improvement. QA professionals work across various industries, from software development to manufacturing, to safeguard customer satisfaction and comply with regulatory requirements.
