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Quality Assurance Technical Lead

Date: Mar 31, 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.

 

 

Summary

The Quality Assurance Technical Lead will report directly to the Quality Assurance Lead and have a direct report(s).  The Technical Lead will be primarily responsible for:

Providing Quality support for internal manufacturing processes, including

  • Providing guidance to staff and junior members of team
  • Reviewing executed batch records
  • Reviewing/evaluating and/or writing product and facility investigations, and draw conclusions in terms of product disposition
  • Reviewing and evaluating CAPA and Change Controls from a technical perspective 
  • Generating metrics which monitor the quality and timeliness of DI, CAPA and Change Control quality records
  • Representing Quality on any manufacturing and QC projects in support of manufacturing activities
  • Participating in implementation of key improvement initiatives and helping solve compliance issues in partnership with business process owners.
  • Provide technical and quality input to BPDRs and quality related questions from regulatory agencies.
  • Provide quality oversight of technical transfer activities into and out of the internal manufacturing facilities.

 

 

Responsibilities

50%       Conduct record review of executed production records for reagents, bulk drug substance, drug product and packaged lots.  Support deviation investigations initiated by Spark Manufacturing team. Review and ensure adequate root cause analysis is performed. Confirm evidence of on-time closure for product disposition.  Provide oversight and review of CAPA, CAPA action plans for appropriateness and ensure timely closure and completion of related documentation prior to lot release.  Review and provide quality input to Change Controls and ensure documentation related to lots are completed and closed prior to lot release.  Provide QA Support for the authoring and review of Regulatory filings for Clinical distribution to the FDA and ROW.

Prepare certificates of compliance (CoC) and/or certificates of analysis (CoA) for products for clinical and/or commercial materials

 

 

40%       Assist in generation of quality metrics for CAPA, Deviation/Investigation and Change Control.  Evaluate for trends and propose solutions/process improvements to mitigate negative trends.  Increase the compliance profile by identifying gaps within processes and procedures.  Review, write, revise, approve SOPs, technical documents and reports.  Supports internal audits, inspections, FDA, EMA inspection readiness, certifications, tracking, and trending activities Assist in regulatory audits

 

5%         Provides quality input on a variety of compliance related issues and attends meetings as a quality representative

 

5%         Other assigned responsibilities as established by QA Lead:

Support QA Operations, Manufacturing, QC and other cross-functional teams to achieve business goals and objectives.

  • Foster Spark’s Culture.  Role model the Spark Values. Create an environment where team members thrive 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.
  • Hire & Integrate.  Know what skills, experiences and capabilities are needed to achieve current and future business goals. Take an active role in attracting and selecting talent who are inspired by our Mission, Vision and Values.  Consciously create a team with diverse backgrounds, experiences, skill sets and perspectives.  Help new team members successfully integrate into Spark so they can actively contribute and add value as quickly as possible.
  • 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, holding 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 continuously communicating priorities, decisions and changes; adjusting goals as needed.  
  • Develop people.   Understand each individual team member’s career 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 and stretch opportunities.

 

 

 

Requirements

  • BS/BA in Chemistry, or Life Sciences; may substitute relevant experience for education.
  • 5-10 years of experience in a regulated quality and/or manufacturing environment, preferably in biotechnology or pharmaceutical industries.
  • Knowledge of relevant governmental regulations, cGMP and guidelines (US, EU, and other territories where Spark products are distributed)
  • Ability to communicate effectively with a wide range of personnel/cross-functional teams
  • Solid technical writing skills related to investigation reports
  • Strong analysis and problem-solving skills, including but not limited to, the ability to review and analyze Manufacturing, Quality Control and Validation data
  • Must be knowledgeable and capable in the following areas:
    • cGMP and FDA/EMA biologics, cellular and human gene therapy regulations preferred but not required
    • Production of human gene therapy products preferred but not required
    • Process and analytical validation (preferred)
    • Quality Management Systems (Change Control, Deviation/Investigations, CAPA)
    • Ability to lead (as necessary) and participate on cross-functional teams


Nearest Major Market: Philadelphia