Director, Quality Engineering

The Quality Engineering (QE) Director is responsible for overseeing Quality Engineering teams who support validation and qualification of equipment, facilities/utilities and cleaning validation activities for API manufacturing at both Bachem America’s locations (Vista & Torrance).  The incumbent will provide leadership and guidance to the QE managers and QE employees. The QE Director will lead the harmonization of validation processes at both Bachem sites. This position is responsible for managing, developing and implementing validation processes to ensure products meet the appropriate regulatory agency’s validation requirements, internal company standards and current industry practices. This position will work in close cooperation with Manufacturing, Engineering and other functional areas in managing validation activities under the QE scope of work.  Responsible for presenting validation practices during the regulatory agencies and customers audits.

MINIMUM QUALIFICATIONS

Required:

• Bachelor’s Degree in science related field (engineering, chemistry, or equivalent)
• Minimum of 10 years pharmaceutical validation experience (cleaning, equipment and facilitates/ utilities) including experience in writing and execution of protocols, reports and operating procedures
• At least 5 years of experience in people management and leadership
• Experience in drug GMP manufacturing
• Strong knowledge of GMPs, FDA & EU guidelines/requirements related to validation
• Experience with root cause analysis, failure mode analysis and analyzing complex technical problems. Possess sound technical judgement
• Experience in writing standard operating procedures and technical reports
• Excellent written and oral communication skills
• Proficient computer knowledge, including Microsoft Word, Excel and PowerPoint
• Ability to effectively organize, multitask, and work in a fast-paced, deadline driven work environment
• Ability to communicate in a proactive and solution-focused manner, including keeping management aware of potential issues
• Ability to work independently and manage one’s time
• Communicate effectively and ability to function well in a team environment

Preferred:

• Master’s Degree in science related field
• Six Sigma Green or Black Belt

• ESSENTIAL FUNCTIONS AND RESPONSIBILITIES

• Hire, manage, and develop teams to support validation activities at both locations
• Manage continued growth, development, and retention of the team
• Set strategic direction for the QE organization
• Responsible for making key decisions and formulating policies that are aligned with strategic objectives of the QE function and Bachem
• Collaborate with Manufacturing, Engineering, QA and other functional areas in managing validation activities under the QE scope of work
• Provide equipment, facilities/utilities qualification guidance and strategy during project planning and development phases
• Develops key performance metrics that measure the effectiveness of the QE organization
• Develop validation master plan (VMP) to assure compliance with regulatory requirements
• Oversee or independently develop a cleaning validation strategy for equipment and parts. Develop and execute or approve cleaning validation protocols and generate validation reports
• Oversee or independently plan and execute validation studies for equipment, facilities/ utilities and cleaning
• Write validation protocols, validation final reports and Standard Operating Procedures (SOPs), and technical reports
• Draft or review and approve validation documentation (requirements specifications, risk assessments, validation plans, IQ, OQ, and related reports, and validation summary reports, etc.) using defined procedures
• Conduct and document investigations related to validation activities
• Support the change control process by reviewing proposed changes, performing risk assessments, and assessing the adequacy of verifications and validations
• Demonstrates commitment to the development, implementation and effectiveness of the Quality Management System per FDA, and other regulatory agencies requirements. Contribute to GMP systems improvements