Director, QC Analytics - Lead Testing & Data Integrity

Rentschler Biopharma, Inc.; Milford (MA); Hybrid; USD 180,000 - 210,000; Full time

Benefits offered by this job

Discretionary bonus program

Medical insurance

401K program

Job summary

Rentschler Biopharma, Inc. in Milford, MA, is seeking a Director of Quality Control - Analytics to lead the QC Analytics team, ensure timely release testing, and safeguard data integrity across raw materials, intermediates and final products.

The role collaborates with QC Technical Services, drives CAPA, manages investigations, and oversees documentation in line with GMP standards to support regulatory submissions and inspections.

Qualifications

• Bachelor's or Master's degree in Chemistry, Biochemistry or related life science with hands-on QC experience.<br/>
• 15+ years in GMP QC, with at least 5+ years in leadership and project management.
• Strong leadership, accountability, and drive to meet objectives.

Responsibilities

• Leads QC Analytics team and laboratory activities.
• Hire and develop employees within the department, with clear expectations for success.
• Provide active feedback, coaching and employee development.
• Participate in Milford Site Quality Leadership team meetings and follow up action plans.
• Collaborate within QC to support authoring, review and/or approval of QC related documents per GMP standards.
• Support the team in managing OOS/OOT investigations, deviations and CAPA as it relates to QC.
• Represent in customer and authority audits and implement corrective measures.
• Responsible for supporting operational aspects of the QC Analytics laboratory, including data verification, PO management, records management, etc.
• Drives continuous improvement initiatives to enhance productivity and efficiency within QC.
• Collect and report quality control metrics via Quality Management Reviews and the Quality Council.
• Promotes a strong Quality Culture based on the Rentschler core values.

Skills

GMP QC expertise

Leadership & management

Regulatory knowledge

Cross-functional collaboration

Quality data integrity

Education

Bachelor's or Master's in Chemistry/Biochemistry or related life science

Job description

Rentschler Biopharma, Inc. in Milford, MA, is seeking a Director of Quality Control - Analytics to lead the QC Analytics team, ensure timely release testing, and safeguard data integrity across raw materials, intermediates and final products.

The role collaborates with QC Technical Services, drives CAPA, manages investigations, and oversees documentation in line with GMP standards to support regulatory submissions and inspections.