Director, Quality Assurance Operations

Rentschler Biopharma is a leading global contract development and manufacturing organization (CDMO) for biopharmaceuticals. From our headquarters in Laupheim, Germany, and our site in Milford, MA, USA, we offer end-to-end solutions, including bioprocess development and manufacturing, as well as related consulting activities such as project management and regulatory support. In Stevenage, UK, we have launched Rentschler ATMP Ltd. dedicated to cell and gene therapies.

We are a family-owned company with approximately 1.400 employees from 25 nationalities. What unites us at Rentschler Biopharma, is the passion for what we do. We empower our clients to help patients with serious or rare diseases. With our dedication and expertise, we convert medical research into outstanding biopharmaceuticals. Thus, we provide an important contribution to the global availability of essential therapies.  Going forward, we are expanding our team to ensure our long-term sustainable growth. Join us and be part of a unique journey, shaping the future of biopharmaceutical manufacturing together!  

Duties and Responsibilities

• Member of the Quality Leadership Team at Milford responsible for leading, coaching, and developing employees within the site-based Quality Operations team
• Ensure compliance with all applicable provisions of the company’s Quality Management System, and the regulations and standards applicable to Milford operations
• Oversee/manage the daily activities for the Quality Operations group including batch record review, disposition of raw materials, disposition of bulk drug substance, project team initiatives including interactions with clients, Quality on the Floor, Quality review of facility alarms, calibration, validation and preventative maintenance activities
• Understand and ensure conformance to GxP regulations applicable to biologics manufacturing. Interface with regulators and clients during inspections/audits
• Conduct gap analyses and implement improved quality management system procedures that are aligned/harmonized with other Rentschler sites
• Participate in or lead quality assessments of internal operations to analyze compliance and assess risk
• Seek new ways to improve and streamline current business and system processes that may span multiple functional areas or departments
• Identify, manage, and where appropriate, lead multiple process/product improvement projects with the objective of achieving quality, efficiency, and cost improvements
• Perform other duties as assigned

Qualifications

• Bachelor’s Degree in STEM
• 15+ years’ experience in the biotech industry
• 5+ years’ experience in a Quality management role
• In depth knowledge of the regulatory environment for manufacture of biological products
• Good verbal and written communication skills
• Experience in coaching and developing individuals and teams
• Ability to interact and communicate with all types of personalities in an effective and diplomatic manner
• Critical thinking and demonstrated problem solving skills
• Good technical knowledge/ understanding
• Prior experience in continuous improvement methodologies is a plus

Preferred Qualifications

• Hands-on experience in the QA oversight of manufacturing and QC activities in a GMP facility

Working Conditions

• Office environment
• GMP manufacturing and QC environments

Physical Requirements

• PPE as required