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.
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.
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.
Internal Number: QUALI02969
About 2409 Research Blvd. Fort Collins, CO 80526
As a privately held company, Tolmar takes pride in our ability to be both flexible and responsive. We strive to provide a level of service to all our stakeholders that is unmatched. Tolmar is comprised of a high-performing team of more than 700, who are united by our passion, mission and vision. With our state-of the-art manufacturing facilities headquartered in Northern Colorado, along with our proven research and development, clinical development, regulatory and production capabilities, Tolmar is an established, sought-after partner.