Clinical Quality Function Lead

Employer
Spark Therapeutics
Location
Philadelphia, Pennsylvania. Hybrid and remote options available for select opportunities.
Salary
Salary not provided
Closing date
Aug 20, 2022

View more

Discipline
Other, Manufacturing/QA/QC
Organization Type
Pharma

Job Details

Primary Duties

The Clinical Quality Assurance (CQA) Lead will report directly to the Head of Quality Assurance and will be responsible for developing and leading the CQA and Global Pharmacovigilance (GPV) Quality Assurance teams that will drive the GCP, and GPV Quality Framework. The Clinical and GPV Quality Assurance Lead will support and provide Quality oversight of clinical development and pharmacovigilance activities. The incumbent will provide assurance to the company that clinical studies, and pharmacovigilance are following all applicable regulatory requirements (US/EU/ROW), company policies/ SOPs, and GCP/ GVP guidelines. The incumbent will be responsible for developing, improving and maintaining Phase Appropriate Quality processes and procedures for these activities. The incumbent will be recruiting, developing, and leading a team of CQA and PV quality professionals.

Responsibilities

  • Serve as the primary contact in QA for the oversight of Clinical Studies in US, EU and ROW to ensure compliance with all GCP’s from manufacturing, labeling, distribution and site qualification to ensure compliance with all Regulatory requirements in the country the study is conducted
  • Liaise with the Head of Clinical, Medical Affairs and Regulatory as needed for the Clinical studies
  • Establish/ensure/remediate as needed the current quality processes, systems and procedures associated with clinical studies
  • Establish/, maintain phase appropriate Quality Systems for clinical studies as well as pharmacovigilance
  • Serve as the primary contact for all Regulatory inspections related to Spark sponsored Clinical, and PV activities. This includes on site at Spark and remote sites.
  • Ensure robust auditing procedures and practices are in place for GCP, and GPV activities. Manage/Direct contract auditing services / CRO’s as needed.
  • Maintain in depth understanding of business principles, industry dynamics, regulatory environment, market trends, and specific operational details related to GCP, and GPV QA activities.
  • Effectively recruit, retain, develop, and lead a team of professionals.

Education and Experience Requirements

  • Minimum BA/BS in a life science, or similar scientific discipline (advanced degree preferred)
  • A minimum of 15 years’ biotech/pharmaceutical experience with 10+ years experience in leading CQA, and GPV activities
  • Strong understanding of GCP (e.g., ICH GCP E6 R2, E8; 21 CFR parts 11, 50, 54, 56, 312, 314; European Union Clinical Trials Directive)
  • Experience with QA oversight of multiple clinical studies being conducted simultaneously in US, EU and ROW
  • Experience with senior level interactions and influence with Clinical, Regulatory and Medical Affairs functions.
  • Experience in working in a matrix organization and challenging self and others to continuously learn and improve
  • Experience with regulatory inspections
  • Experience building and growing clinical quality departments

Key Skills, Abilities, and Competencies

  • Understanding of the clinical development lifecycle (ideally for cell and/or gene therapies or other advanced therapy medicinal products)
  • Strong leadership and communication skills with special emphasis on collaboration skills
  • Excellent interpersonal skills, including written and verbal communication
  • Ability to motivate, develop, and inspire his/her team members and direct reports
  • Strong sense of ethics, diplomacy, discretion, and a commitment to Quality
  • Excellent team player attitude
  • 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

Complexity and Problem Solving

  • Ability to influence areas not under direct control to achieve objectives and effectively communicate challenging goals & objectives.
  • Ability to think strategically and to quickly analyze complex circumstances and problems and to drive appropriate decisions and actions
  • Ability to manage competing priorities
  • Ability to interact effectively with Health Authorities and various Spark stakeholders

#LI-2326

Please be aware that Spark mandates COVID-19 vaccination of all employees regardless of work location. Accommodations may be made in accordance with applicable law.


Nearest Major Market: Philadelphia



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.

Company

At Spark Therapeutics, a fully integrated, commercial company committed to discovering, developing and delivering gene therapies, we challenge the inevitability of genetic diseases, including blindness, hemophilia, lysosomal storage disorders and neurodegenerative diseases.

Founded in March 2013 as a result of the technology and know-how accumulated over two decades at Children’s Hospital of Philadelphia (CHOP), our investigational therapies have the potential to provide long-lasting effects, dramatically and positively changing the lives of patients with conditions where no, or only palliative, therapies exist. Greater understanding of the human genome and genetic abnormalities have allowed our scientists to tailor investigational therapies to patients suffering from very specific genetic diseases. This approach holds great promise in developing effective treatments to a host of inherited diseases. Our initial focus is on treating orphan diseases.

Headquartered in dynamic Philadelphia, we are a diverse, experienced team united in our goal to break down barriers for people and families affected by genetic diseases. As our name suggests, our investigational, one-time therapies are designed to spark healthy biology, and deliver potentially life-altering transformation for people and families affected by genetic disease. Spark is a member of the Roche Group.

Find Us
Website
Telephone
215-989-1149
Location
3737 Market Street
Suite 1300
Philadelphia
PA
19104
United States

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