Quality Engineering Supervisor
Employment Type: Full-Time
Purpose and Scope
Coordinate and supervise the activities of the Commercial Quality Engineering Team. Ensure the Annual Product Reviews (APRs) and Continued Process Verification (CPV) reports are completed in a timely manner in compliance with regulatory requirements. Lead Continuous Improvement (CI) projects for the CPV program.
Essential Duties & Responsibilities Supervise the daily activities of the Commercial Quality Engineering Team directly and through employee performance to ensure schedules and performance requirements are met. Organize workflow and ensure direct reports understand their responsibilities and delegated tasks. Teach, mentor, and assist Commercial Quality Engineers and system owners with preparing, trending, and analyzing data for APRs. Ensure that APRs are prepared in a timely manner in compliance with regulatory requirements, including participating in the preparation process. Teach, mentor, and assist Commercial Quality Engineers with preparing, trending, and analyzing data for CPV reports. Ensure that CPV reports are prepared in a timely manner in compliance with regulatory requirements, including participation in the preparation process. Lead CI projects related to the CPV program. Use statistical analysis and six sigma tools to support investigations related to the CPV program. Serve as a QE representative on project teams to define Critical Material Attributes (CMAs), Critical Quality Attributes (CQAs), and Critical Process Parameters (CPPs) for Tolmar’s commercial products. Facilitate and assist Compilation of information and data for Tolmar’s commercial products in a timely fashion. Perform statistical analysis of data, identify trends in the product/process data that can affect product quality, and summarize the results, data analysis, and conclusions in technical reports. Identify, track, and trend Key Performance Indicators (KPIs) for the APRs and CPV program. Determine best practices for processes and procedures to completing new assignments or projects. Maintain policies and procedures related to the APRs and CPV program that are in compliance with regulatory requirements. Identify training needs for direct reports and ensure compliance with training requirements. Monitor employee productivity and provide constructive feedback and coaching. Interact with investigators/auditors during regulatory inspections and marketing partner audits. Perform various other duties as assigned.
Knowledge, Skills & Abilities Working knowledge of cGMPs, ISO, EU, and JP standards for pharmaceutical products. Advanced skills with statistical software packages. Excellent organizational skills and the ability to work effectively in a high paced, fast changing environment. Ability to work well and communicate with employees cross-functionally at all levels. Effective conflict resolution skills. Strong training, coaching, and mentoring skills. Strong supervisory skills with proven team building experience to assure an integral and interconnected team. Demonstrated leadership abilities with the ability to change the behaviors of others through coaching and mentoring. Proficient with computer applications (Microsoft Office Suite and other database applications). Ability to read, understand, and author complex technical documents. Ability to apply logical thinking in order to break complex problems into their component parts. Ability to work independently and in conjunction with a team on multiple projects simultaneously in order to meet time lines. Strong attention to detail, thorough, and efficient.
Core Values The Quality Engineering Supervisor is expected to operate within the framework of Tolmar’s Core Values: Consistently operate with the highest standards of ethics and compliance. Take ownership of your actions, success and setbacks. Respect each other and understand that honest collaboration is at the heart of our company success. Go the extra mile to make things happen. Be committed to all we do and the patients we serve. Embrace change with enthusiasm. Strive to learn about and understand the needs of customers and patients, and take action with great speed and efficiency no matter the task.
Education & Experience Bachelor’s degree in Chemistry, Engineering, Biology, or other related field required. Ten or more years in Quality Engineering or related experience in the pharmaceutical, medical device, or biotech industry strongly preferred. Three or more years of supervisory, team lead and/or project management experience strongly preferred. CSSGB, CSSBB, or CQE required.
Working Conditions Working conditions are normal for an office environment. Work may require occasional weekend and/or evening work. Occasional work inside manufacturing clean rooms where gowning is required.
Bachelors or better in Biology or related field.
Bachelors or better in Chemistry or related field.
Bachelors or better in Engineering or related field.
Licenses & Certifications* The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.
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