Director, Quality Control - Analytics

Rentschler Biopharma•Milford, MA

12h•$180,000 - $210,000•Onsite

About The Position

Advancing medicine to save lives. Together. Thanks to many decades of experience and our passion for what we do, we make an essential contribution to the global availability of biopharmaceuticals, especially for patients with rare and serious diseases. Rentschler Biopharma SE is a leading contract development and manufacturing organization (CDMO) focused exclusively on client projects. We offer customized full-service solutions for bioprocess development and the production of complex biopharmaceuticals. As a German family-owned company with an international footprint and global reach, we combine experts, expertise and years of experience to develop best-in-class solutions – together with our clients. Rentschler Biopharma has approximately 1,400 employees and is headquartered in Laupheim, Germany, with a site in Milford, MA, USA. In 2024, we joined the United Nations Global Compact, underlining our commitment to sustainability. As an independent family-owned company, we live by the motto: Many hands, many minds - ONE TEAM! Open, respectful cooperation characterizes our working environment, where quality awareness, diligence and responsibility are our top priorities. With all the diversity of our talents in the Rentschler team, we pursue one vision together: advancing medicine to save lives. As a member of the Rentschler Biopharma Quality Control leadership team in Milford, the Director Quality Control - Analytics will primarily be responsible for leading a Quality Control team responsible for testing incoming samples (including raw materials, site utilities, process intermediates, final product) and providing timely results that support GxP manufacturing and product disposition. The QC Analytics team is composed of a Analytical technical leader, a department supervisor and QC Analysts that cover 7-day per week testing. This role will collaborate with Quality Control Technical Services to periodically evaluate processes to ensure that QC activities are efficient, timely in terms of delivery of client contract deliverables, and safeguard data integrity. The successful candidate will need to be flexible and agile with the ability to pivot quickly to changing circumstances and business needs.

Requirements

A Bachelor's or Master's degree in Chemistry, Biochemistry or a related life science field with substantial hands-on experience in Quality Control related activities
15+ years of industry experience in a GMP QC environment, with a minimum of 5+ years of managerial and project management experience
Leadership skills to manage technical and laboratory personnel
Strong sense of accountability, self-motivation, and drive in meeting project objectives.
Direct experience in managing and overseeing QC related activities internally and at third party vendors.
Understanding of FDA/EU/ICH regulations and guidance related to critical quality attributes, release testing, analytical validation and transfer, and stability testing.
Proven ability to lead and implement multiple projects/tasks simultaneously with competing and/or changing priorities ensuring effective time management.
Excellent facilitation and project management skills, with strong verbal and written communication skills.
Ability to effectively communicate across all levels and cross-functional teams.
Ability to work independently as well as collaboratively in a team environment.

Responsibilities

Leads QC Analytics team and laboratory activities
Hire and develop employees within the department, while setting 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 ensuring all appropriate documents are generated and retrievable per GMP standards in support of regulatory submissions and inspections
Support the team in managing OOS/OOT investigations, deviations and change controls, and implementing appropriate CAPA as it relates to QC
Provides representation in customer and authority audits and implementation of resulting 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