Job Description

Fully Onsite (5x/week) in New Castle County, DE.

Client offers relocation assistance from anywhere in the United States.

Responsibilities:

• Manage a team of Quality professionals and compliance consultants, including oversight of quality processes and systems at the site.
• Manage resource plan for both internal and external resources to support the site project plans. This includes allocation of resources to projects and activities to ensure compliance with quality requirements and timelines.
• Recruit new staff and ensure that they receive proper qualification and training, including EHS training and IP protection policies. Accomplishes staff results by communicating updated organizational information, job expectations & supporting their work.
• Continuously coach, develop, monitor, and appraise direct reports, including performance management, goals & job results.
• Provide leadership and quality qualification guidance to support the successful execution of design, construction and qualification of the new facilities along with future engineering projects.
• Develop and implement a quality system to meet regulatory requirements and customer expectations.
• Review and approve facility and equipment qualification documentation and quality system documentation to support ongoing site projects.
• Lead and/or supervise quality issue resolution in a timely manner to ensure smooth progress of the site projects. This includes implementation of solutions and preventive actions
• Host or assist during Health Authority inspections and ensures successful completion of these inspections
• Host or assist during Client audits and ensures successful completion of these audits.
• Organize Quality management reviews to drive quality and continuous improvement. Report significant quality issues to senior management.
• As needed, drive customer communication and drive customer satisfaction.
• Interface with other Site Leaders to coordinate quality and compliance activities
• Contributes to the overall operations and to the achievement of Site goals and objectives.
• Performs job-specific tasks in compliance with applicable Regulations, International Standards, and Company Policies and Standard Operating Procedures.
• Demonstrates thorough understanding of, and implements, Good Manufacturing Practices.

Qualifications

• Bachelor’s degree in Pharmaceutical, Chemical or analytical sciences, Master’s and PE preferred or equivalent experience
• Minimum 10+ years of relevant experience or equivalent in pharmaceutical quality assurance and/or facility and equipment qualification. Including proven ability in people leadership and team development
• Proven Quality leadership experience in a CDMO environment preferred
• Be proficient in pharmaceutical manufacturing processes (drug substance and drug product) and GMP regulations.
• Strong hands-on leadership style
• 20% travel is required; both domestic and international

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