Associate Director / Director Quality
Job Locations US-NH-Lebanon
ID: 2021-2854 Category: Quality Type: Full-Time
Overview
This role will be the Associate Director/Director of Quality for the Avitide site and part of the functional leadership team for Avitide. The successful candidate will drive the site-wide implementation of quality initiatives and work with Repligen’s global quality team to adopt and share best practices. They will also be a key driver in achieving corporate objectives at Avitide. A pragmatic and flexible yet robust approach to quality and organizational excellence is critical in this role.
Avitide is located centrally to world class outdoor pursuits including hiking, mountain biking, Nordic and alpine skiing, snowboarding, rock and ice climbing, hunting and fishing, and kayaking. Cultural activities such as plays, musicals, concerts, comedy shows, and art festivals are available to the community through nearby Dartmouth College and various opera houses in the area. Farmers markets and community supported agriculture programs make locally sourced food and other goods readily available.
This role will be the Director of Quality for the Avitide site and part of the functional leadership team for Avitide. The successful candidate will drive the site-wide implementation of quality initiatives and work with Repligen’s global quality team to adopt and share best practices. They will also be a key driver in achieving corporate objectives at Avitide. A pragmatic and flexible yet robust approach to quality and organizational excellence is critical in this role.
Avitide is located centrally to world class outdoor pursuits including hiking, mountain biking, Nordic and alpine skiing, snowboarding, rock and ice climbing, hunting and fishing, and kayaking. Cultural activities such as plays, musicals, concerts, comedy shows, and art festivals are available to the community through nearby Dartmouth College and various opera houses in the area. Farmers markets and community supported agriculture programs make locally sourced food and other goods readily available.
Responsibilities
Overseeing the maintenance and improvement of the site’s ISO 9001-accredited quality systems and processes.
Formalizing and implementing the site and commercial resin production training programs.
Driving development and implementation of a robust master validation plan, including process, equipment, cleaning, and method validation.
Be an active participant in the product development life cycle and related processes.
Fostering the development and growth of processes in support of the site Quality Policy.
Aligning quality objectives, key performance indicators, and operating practices are aligned with Repligen corporate objectives.
Promoting data-driven and evidence-based decision making through the use of statistical analysis and quality tools.
Empowering individual contributors to propose solutions to improve efficiency, productivity, and to minimize waste.
Encouraging collaboration between groups to implement new processes, ideas, and solutions.
Holding team accountable for deliverables and deadlines.
Integrity, collaboration, initiative, and creativity in problem solving are required characterstics both for the candidate and as values to be encouraged with the team.
Qualifications
10+ years of quality-related experience in biotech, pharma, or related fields
B.S. or higher in life science
Understanding of regulatory requirements and processes for drug filings
Experience with validation and statistical analysis and related software (e.g., JMP)
Familiarity with ISO 9001 quality management systems
Familiarity with quality tools and experience coaching others in their use (e.g., FMEA, 5S, Six Sigma, flow charts, root cause analysis and problem solving techniques)
Fluency with Microsoft Office Suite – particularly Powerpoint, Word, and Excel
Ability to operate or learn ETQ Reliance quality management software
https://careers-repligen.icims.com/jobs/2854/associate-director-director-quality/login
