Principle Quality Engineer

Job Title

Requisition

Location

Additional Locations

Job Description Summary

Job Description

SUMMARY OF POSITION:

Serve as a key member of the Quality Systems organization by managing the development, establishment, and maintenance of quality programs, including policies, processes, procedures and controls, ensuring that performance and quality of cGXP documentation conforms to established standards and requirements. The scope of the position includes also the management of the Sector Audit and Supplier programs, including the Webster Groves Sector functions and the manufacturing sites. Assess the adequacy of Quality Systems, processes and programs throughout the sector. Provide leadership and technical expertise the Quality System development, deployment, and maintenance.

The incumbent will work with colleagues within Quality Operations (e.g., internal manufacturing sites) and others to ensure that these quality systems are maintained and managed in full GXP compliance. The incumbent will be relied upon for sustained success for future strategic initiatives.

The Principal Quality Engineer will be reporting to the Executive Director, Quality. The position will lead improvement efforts to ensure alignment and compliance with all applicable regulations and internal requirements to include policies, processes, procedures, guidelines, and other applicable standards to include 21 CFR Parts 210 and 211, ICH Q7A, Q9, Q10 and other international applicable regulations.

ESSENTIAL FUNCTIONS:

Manage the self-inspection program. Manage the supplier quality program. Provide backup technical support to the TrackWise System administrator, conduct user training, and support TrackWise system testing and upgrades. Manage the process that develops, establishes, and maintains quality assurance programs, policies, process, procedures and controls ensuring that performance and quality of finished products (active substances for medicinal products for human use, excipients and finished dosage) is in accordance with GxP requirements. Identify, develop, and execute quality plans and project timelines to meet group, site and company goals. Participate in compliance audits and respond to audit observations. Support with FDA and other regulatory agencies investigations, inspections, and inquiries as needed. Interact with corporate support groups to drive quality programs. Serve as cGXP compliance subject matter expert. Complete technical and other quality duties as assigned.

MINIMUM REQUIREMENTS:

Education:

BS/BS in related field

Experience:

10-15 yrs experience in manufacturing and control of pharmaceutical manufacturing and/or Quality with extensive FDA and global regulatory experience.

Preferred Skills/Qualifications:

• Thorough knowledge of cGMPs/cGXPs pharmaceutical requirements
• Must be proficient at technical and compliance understanding of quality processes associated with quality, CAPA, deviations/exceptions, root cause analysis, change control and quality concepts in a distribution center/commercial office environment.
• Independent who needs little guidance or follow up once projects/tasks are assigned.
• Proficient at multi-tasking, well organized and reliable for consistent decision making and follow through.
• Demonstrated auditing and corrective action proficiency
• Demonstrated record of successfully assessing and determining the impact of current and potential regulatory compliance issues
• Demonstrated proficiency of root cause analysis as applied in a pharmaceutical manufacturing environment. Excellent problem solving and decision-making skills.
• Ability to manage and drive change
• Computer skills
• Knowledge of document management/quality systems
• Direct experience with Regulatory inspection highly preferred

Skills/Competencies:

• Project management
• Good computer skills, including proficiency with business and technical software (Work, Access, Excel, Powerpoint)
• Ability to identify and drive continuous quality improvement

Other Skills:

• Ability to matrix manage projects with multiple functional groups without direct reporting authority
• Strong communication and interpersonal skills
• Getting work done through others that are not direct reports
• Operates with minimal direction
• Building relationships with other departments
• Statistical Analysis capability

ORGANIZATIONAL RELATIONSHIPS/SCOPE:

Reports to Executive Director, Quality

Two or more direct reports

Frequent communication and working relationships with Business unit Management and Plant Management

WORKING CONDITIONS:

Employee will work in a normal office environment.

Occasional travel (less than 20%)

DISCLAIMER:

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.