Associate Director, Quality Systems & Materials

  • Direct Hire Positions
  • Exton, PA

Title:  Associate Director, Quality Systems & Materials

Location: Exton PA

Direct Hire

 

Qualified candidates will have:

  • At least 10 years’ experience in a cGMP environment
  • At least 5 years’ leadership experience in a Quality organization
  • BS in Life Sciences or equivalent
    Additional requirements below

 

Responsibilities: 

  • Directly manage teams that oversee Quality Systems, Materials, Document Control, and CMO Program Management
  • Direct department activities related to planning and implementation of continuous improvement of Quality Systems
  • Provide guidance and leadership to the DQA team to ensure decisions are made using regulatory knowledge, industry standard practices, engineering and scientific principles, and technical knowledge
  • Lead and be responsible for Quality Assurance activities when the Sr. Director is not available

The Associate Director also acts as Deputy Quality Head, partnering with the Sr. Director Development Quality Assurance-US (DQA-US) to lead and be responsible for Quality Assurance for:

(a) all clinical and commercial GxP biologic activities overseen by the Quality Assurance team in Exton;

(b) all GMP activities at Contract manufacturing, testing, packaging, and distribution organizations for US clinical trials (small molecules);

and (c) companion diagnostic activities.

 

This role is responsible for all aspects of GxP Quality Assurance, including ensuring appropriate operating philosophies, Quality Culture, staffing, and Quality Systems align with Company Global Standards and international cGMP regulations.

The teams have the following responsibilities:

Quality Systems oversight 

  • Business Owner, Lab Administrator, and Quality Contact of LIMS
  • System Owner and Quality Contact of TrackWise
  • Quality contact for SAP
  • Administration for Exton SharePoint

Materials oversight for both clinical and commercial operations 

  • Disposition of incoming goods used in the Biologics facility
  • Disposition of products manufactured in the Biologics facility

Document Control for the Biologics facility 

CMO Quality oversight 

  • Cell banking
  • Bulk Drug Substance
  • Packaging, labeling, and Distribution
  • External Testing Laboratories

 

Job Qualifications
Education:
• BS in Life Sciences or equivalent

Experience:
• At least 10 years’ experience in a cGMP environment
• At least 5 years’ leadership experience in a Quality organization
• Experience with Quality Systems (LIMS, SAP, TrackWise)
• Knowledgeable in biologics manufacturing
• Knowledgeable in FDA, EU and JP CMC regulations for both clinical and commercial operations
• Leadership experience implementing complex systems and interacting with diverse and international multidisciplinary teams
• Possess a hands-on proactive stance with excellent interpersonal skills and a willingness and ability to assist all team members to achieve the project goals
• Ability to set priorities and achieve goals; strategic thinking, energy, and enthusiasm
• Excellent interpersonal skills
• Excellent written and communication skills
• Ability to supervise, mentor, train, and develop staff
• Auditing skills preferred

  • Accepted file types: doc, pdf, txt, docx.