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Validation Leader

Date: Aug 14, 2019

Location: Philadelphia, PA, US

Company: Spark Therapeutics

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.

Summary

The Validation Leader will be responsible for the Commissioning, Qualification and Validation (CQV) strategy, direction and execution of CQV and related activities.   He/she will establish operational objectives and assignments to ensure effective management of the overall CQV program for Spark’s growing multi-site cGMP and Scientific facilities infrastructure.  This individual will be tasked with overseeing the CQV of new and legacy utilities, process and support equipment, analytical instrumentation, cleaning, temperature-controlled shipping and computer systems validation (CSV) for all cGMP and scientific facilities.

 

Through effective and efficient management of subordinate staff, oversight of external vendors and “hands on” workload, ensures that CQV work follows safety standards, conforms to end-user requirements/specifications, cGMP compliance, and that CQV activities are tracked and completed within the budgeted guidelines of schedule and costs.

Responsibilities

As a functional manager, is responsible for all projects assigned to the department.  Acts as an advisor to cross-functional team members to meet schedules (routine Manufacturing and/or special projects) and resolve technical or operational concerns. 

Directs, prioritizes and coordinates the daily activities of the Validation staff for new (start-up) and legacy utilities, process and support equipment, analytical instrumentation and CQV systems.  These activities include planning, scheduling, execution and documenting (protocols/reports/revalidation assessments) IQ/OQ/PQs activities.

Maintain compliance by monitoring performance over time and developing and maintaining key performance indicators to provide a basis for the periodic reporting of metrics.  Design, implement, manage and monitors the revalidation program.

Works cross-functionally under consultative direction to lead and/or participate in deviation investigations (DIs), perform corrective and preventative action (CAPAs), and effectives checks.  Review/Author standard operating procedures (SOPs) and change controls (CCs) based upon solid understanding of regulatory and Spark requirements as well as best and proven industry guidelines.

Develop and manage budgets, schedules and performance standards for areas of responsibility, including staffing requirements

Manage Validation team to achieve business goals and objectives.

  • Manage performance.   Ensure every team member knows what is expected of them, what it takes to be successful, and how they are progressing.  Provide team members with continuous and on-going performance feedback.  Hold everyone accountable to achieve results while demonstrating the Spark Values. Help team members understand how their work contributes to the overall success of Spark by periodically reviewing individual objectives to ensure alignment to corporate and functional objectives, making adjustments if priorities have shifted.
  • Develop team members.   Help employees effectively assimilate to Spark and continually grow through challenging experiences so they can realize their full potential.  Understand your employee’s goals, strengths and motivators.  Partner with your employees to identify areas for development, conduct coaching conversations regularly and provide guidance on ways to develop through on the job experiential learning, social networks and development opportunities.
  • Foster Spark’s Culture, Mission, Vision, and Values:  Lead by example.  Create an environment where team members thrive in our Culture by living our truths, always in compliance with applicable laws and regulations. Emphasize to employees that “how” they achieve performance objectives is just as important as “what” they accomplish.

 

Requirements

● Bachelor’s degree in an Engineering or Science-related field is required.  An advanced degree is   preferred.

● Must have fifteen plus (15+) years of experience managing Validation functions within the pharmaceutical/biotechnology industry.

● Experience working within established standards and industry guidelines: FDA; GAMP; ISPE; ASME, cGMP; GEP; ISO; GDP, etc.

● Specific knowledge of computer validation methodologies and principles to perform CSV on a variety of systems and programs.

● Must have direct experience in the commissioning, qualification and validation of facilities, utilities, production, laboratory and support equipment.

Competencies

● Strong analytical, written/verbal communication and interpersonal skills

● Ability to multi-task and work independently or in a team environment with minimal supervision

● Proficiency in prioritization, organization, and time management


Nearest Major Market: Philadelphia