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DI & GxP Systems Compliance Lead

Date: Jun 24, 2021

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.

 

Job Summary:

 

This role will responsible for providing data integrity and regulatory guidance and oversight for GxP systems throughout the system lifecycle (i.e. plan, implement, run & operate and retire) at Spark Therapeutics.  The role focuses on ensuring compliance with company policies, procedures and regulatory expectations of FDA and other major international health authority regulators for all GxP computerized systems. The incumbent will work closely with stakeholders spanning across Research Labs, Pre-Clinical and Clinical, Manufacturing, Quality Control, Facilities and IT in cross-functional programs to ensure a consistent approach across the organization. Participate on project representing QA as determined by QA CSV & DI Leader.

 

Primary Responsibilities:

 

  • Provide day to day oversight for the governance, management and coordination of activities related to the Data Integrity Governance Program including implementing and maintaining Data Integrity compliance activities across the end-to-end product lifecycle and across all sites and internal functions in alignment with relevant governmental regulations and guidelines. 
  • Develop, review, approve, provide inputs to processes, policies, and procedures required for data integrity governance and implementing GxP computer systems in compliance with major health authority regulations and Spark internal processes.
  • Provide independent quality review and approval of key qualification/validation documentation for DI and GxP computer systems implementation.
  • Provide day to day oversight for the governance, management and coordination of activities related to the Data Integrity Governance Program including implementing and maintaining Data Integrity compliance activities across the end-to-end product lifecycle and across all sites and internal functions in alignment with relevant governmental regulations and guidelines.
  • Provide subject matter expertise in regulatory requirements, expectations, specifications/methods/compendia, manufacturing technology, and quality assurance.
  • Support regulatory inspections and audit activities of GxP computerized systems.
  • Drive resolution to data integrity and regulatory non-conformance of GxP computerized systems (audit/inspection outcome or otherwise)
  • Support assessment and evaluations of deviations, as appropriate, based upon Spark Manufacturing team and/or Contract Manufacturing Organizations (CMO) and/or Contract Technical Laboratories (CTL) notification; confirm evidence of on-time document closure for product disposition.
  • Facilitate assessments to support Deviation/Investigations, Change Controls, CAPAs, and/or other required documentation for internal manufacturing and development activities.
  • Participate in Data Integrity and CSV projects as assigned.
  • Manage direct reports (Spark or non-Spark) directly and/or lead matrix teams as assigned.
  • Collaborating with key stakeholder – business owners, system owners and IT to
    • Assess/select computer systems to ensure technologies meet high level business needs of GxP functions
    • Ensure that the project tailoring is appropriate for the complexity and risk to accommodate full scope of work
    • Assure that all systems have quality approved operating level procedures and plans to maintain validated status of GxP computerized systems including health of such systems
    • Benchmark within and outside of the Company, including regulatory agencies, business partners and suppliers

 

Education and Experience Requirements:

 

  • Minimum BA/BS in a life sciences or engineering/computer science or similar scientific discipline (advanced degree preferred)
  • A minimum of 7 years’ experience and in-depth knowledge of data integrity requirements and GxP computer system validation, and Part 11 requirements in a Pharmaceutical or Biotech environment including understanding software development and supporting validation IT systems in manufacturing and/or laboratories 
  • In depth understanding of regulations (FDA/EU/ICH), with emphasis in 21 CFR Part 11, 210, 211, 58 and 820 and local regulations for assigned areas.
  • Proven experience in the interpretation and understanding of cGxPs for the controlled management of paper and electronic records and signatures.
  • Cross-functional experience in QC, QA, Validation and Manufacturing is desired
  • Experience with senior level interactions and influence with Manufacturing Operations, Regulatory, R&D, Medical and Commercial functions.
  • Experience in working in a matrix organization and challenging self and others to continuously learn and improve.
  • Preferred Competencies and Skills: Lean Six Sigma, Project management (PMP), or other applicable professional certifications

 

Key Skills, Abilities, and Competencies:

 

  • Deep understanding of regulations and compliance requirements for GxP computer systems
  • Depth of general IT skills and domain specific technology knowledge to help business understand technology, navigate through technical complexities, act as liaison between business and IT driving collaboration required to identify and install technology capabilities aligned with Spark strategy, identify risks and risk based options for efficient risk mitigation and provide guidance/develop path forward plans for project installation
  • Soft skills like process improvement, facilitating meetings to help business articulate user requirements, manage projects as necessary and develop presentations for effective communication.
  • Excellent interpersonal skills, including written and verbal communication.
  • Strong sense of ethics, diplomacy and discretion.
  • Commitment to Quality.
  • Excellent team player attitude.
  • Demonstrate strong leadership capability with ability to make and act on decisions while balancing speed, quality and risk.
  • Ability to work in a matrix environment and build strong relationships by being transparent, reliable and delivering on commitments.
  • Ability to provide innovative ideas to improve quality and compliance that create value including seeking new information and external insights.
  • Ability to manage competing priorities
  • Excellent verbal and writing skills
  • Ability to interact effectively with Health Authorities and various Spark stakeholders

 

Other Job Requirements:

 

  • The ability to travel approximately 10%, domestic and international

 

 

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Nearest Major Market: Philadelphia