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Document Control Systems and Processes Lead

Date: Jul 31, 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 incumbent leads QA Ops teams on multiple process improvement projects from inception through completion, while adhering to project scope, schedule, quality and budget. The incumbent must possess strong communication skills and must work with both Quality and business partners across the organization in a collaborative way. In this role, the incumbent will work with the QA Operation Lead to identify process improvement initiatives within the QA group. Working across boundaries to ensure project work complies with established practices, policies, and processes. Project issues and risks must be identified. tracked and plans to resolve these issues must be developed and solutions executed.

 

Reporting to the Quality Assurance Operations Lead, this position is accountable for the successful and timely completion of projects within Quality Assurance including:

  • Implementation of DMS and QMS systems
  • Manage integration between the LMS and DMS systems, as applicable
  • Responsible for KPI Management and Reporting
  • Identifies and implements Process Improvements
  • Leads Lean Excellence/Standardization of processes including issue identification and resolution for processes managed by the QA Ops group
  • Oversees Document Retention and File Room Management
  • Manages and Maintenances the Risk Register
Responsibilities

45%      

•            Working with the Doc Control & Quality Systems, leads the implementation and administers new electronic systems and solutions.

•            Responsible for successful strategic project execution & delivery, team management, prioritization, resource planning, execution tools, training and monthly reporting as they apply to assigned projects and new and improved processes.

•            Leads cross functional workstreams Work to standardize processes within the QA Ops organization as well as helping the Manufacturing areas standardize their processes.

•            Responsible for working with QA Ops Lead to identify and develop process improvement initiatives within the QA Ops group.

•            Responsible for scheduling and leading cross functional meetings to discuss and document review of metrics and other Quality metrics, issuing meeting minutes and following up on action items.

30%      

•            Oversee/manage the Document Retention program, management of the SharePoint sites, Scanning critical documents and GMP file room.

•            Responsible for providing input and guidance and may advise the QA Operation Lead in the overall systems’ strategy.

•            Work in partnership with cross functional groups to foster partnerships with customers/stakeholders/sponsors. Chairs project team meetings and is responsible for coordinating moderately complex team operations and communications.

Responsibilities (cont'd)

15%      

•            Directs project communications and is accountable for ensuring that all project customers are fully informed and knowledgeable of project activities and their status.

•            Leads the design, implementation, and update of project plans, which form the operational basis for the project team. Ensures that project plans optimize the integration of timing, scope and resources.

•            Collaborates with functional leaders to ensure that functional area resources are sufficient to achieve project goals and objectives.

10%      

•            Manage performance of every team member, provide continuous and on-going performance feedback, hold every team member accountable to achieve results while demonstrating the Spark Values.  Ensure individual objectives align to corporate and functional objectives.

•            Develop team members by continually growing employees through challenging experiences, identify areas for development, actively coach, provide development and learning opportunities.

•            Foster Sparks Culture and lead by example.  Create an environment where team members thrive in Spark’s culture by living our truths, always in compliance with applicable laws and regulations.

•            Emphasize to team members that how they achieve performance objectives is just as important as what they accomplish.

Qualifications

•            Excellent interpersonal, organizational, and written and verbal communication skills.

•            Must be able to support multiple project teams simultaneously.

•            In-depth knowledge and skill with Microsoft Project, Microsoft Excel and other reporting and tracking tools.

•            In depth working knowledge of electronic Document Management/QMS systems

•            Must be well organized and have a strong attention to detail.

•            Ability to work under limited supervision, determine personal work plan, and schedule tasks and activities.

•            Ability to work both independently and in a team environment.

Requirements
  • BS required; or master’s degree preferred.
  • Minimum of 8+ relevant work experience, preferably in pharmaceutical or biotech industry.
  • Experience working in a regulated environment is required
  • Previous supervisory experience is strongly preferred/required
  • Experience should include participation in cross-functional project management activities.
  • Must have a basic understanding of and application of principles, concepts, practices, and standards of biotech/pharmaceutical project management.
  • Must have solid working experience and solid knowledge of GMP Compliant electronic systems for managing document control, deviations, CAPA's


Nearest Major Market: Philadelphia