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Regional Director - Direct Placement in exton at Collabera

Date Posted: 9/22/2018

Job Snapshot

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Job Description

The Associate Director, Quality Systems & Materials directly manages teams that oversee Quality Systems, Materials, Document Control), and CMO program Management.

The teams have the following responsibilities:
1. Quality Systems oversight
a. Business Owner, Lab Administrator, and Quality Contact of LIMS
b. System Owner and Quality Contact of TrackWise
c. Quality contact for SAP
d. Administration for Exton SharePoint
2. Materials oversight for both clinical and commercial operations
a. Disposition of incoming goods used in the Biologics facility
b. Disposition of products manufactured in the Biologics facility
3. Document Control for the Biologics facility
4. CMO Quality oversight
a. Cell banking
b. Bulk Drug Substance
c. Packaging, labeling, and Distribution
d. External Testing Laboratories

1. Directly manage teams that oversee Quality Systems, Materials, Document Control, and CMO Program Management
2. Direct department activities related to planning and implementation of continuous improvement of Quality Systems
3. 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
4. As Deputy Quality Site Head, 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 Global Standards and international cGMP regulations.

Job Qualifications
• BS in Life Sciences or equivalent
• 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

Job Requirements

SAP, Program Management, Quality Assurance, J2ME, Direct3D, Engineering, Java, Management