Description

Director of Quality

Location: King of Prussia, PA

Job Summary

Prevention of product deviations and defects is paramount in this role. The quality management group is responsible for system wide quality, system implementation and process improvement. The Quality Management group is also responsible for all aspects of pharmaceutical quality assurance including component, intermediate, bulk and finished product release, equipment cleaning verification, qualifying equipment , document management, internal and external audits, regulatory relations, complaint handling, NDA submissions, cGMP training of employees, and other duties as assigned. As a senior member of this group the individual must be able to make decisions and immediately identify and address any issues or concerns with processes before they develop.

What You Will Be Doing

• Review, approval, and release of raw materials
• Support manufacturing and analytical services along with the QA team in all aspects of work to ensure proper procedure is being followed and any issues or concerns are discovered at the source before they develop.
• Document control through management, issuance, authoring, and approval of documents (SOPs, Monographs, Investigations)
• Qualify and manage equipment in the QA databases
• Interact with clients to build relationships to anticipate, meet, and exceed client expectations
• Responsible for the training of all employees with regards to quality and cGMP
• Developing business through new quotations, seeking new clients, interaction with current clients
• Lead supplier, client and FDA audits
• Build and improve quality systems
• Create value for the position, department and company

What You Need for this Position

• Drug development, New Drug Applicant and Regulatory Experience
• Minimum of a Bachelors Degree in a related science field to an accredited US college or university
• Must be a self-starter and capable of working with minimal oversight and able to manage a team
• Proactive Quality by Design, not reactive auditing, root cause analysis
• Must understand and participate in prevention and be able to improve systems and procedures as applicable
• Must be able to work in a fast paced and changing environment and know how to prioritize activities appropriately
• Must be able to understand and develop the business, understand the business as a whole and have involvement in the businesses cash flow where necessary
• Must understand and apply quality

What's In It for You

• Vacation/PTO
• Medical
• Dental
• Vision
• Bonus
• 401k

So, if you are a Director of Quality with pharma experience, please apply today! or Send your resume to Lauren@Cybercoders.com

Email Your Resume In Word To

Looking forward to receiving your resume through our website and going over the position with you. Clicking apply is the best way to apply, but you may also:

Lauren.Formby@CyberCoders.com

• Please do NOT change the email subject line in any way. You must keep the JobID: linkedin : LF2-1530419 -- in the email subject line for your application to be considered.***

Lauren Formby - Recruiting Manager - CyberCoders

Applicants must be authorized to work in the U.S.

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