Director, Quality Control - Analytics

Rentschler Biopharma SE; Milford (MA); Sur place; USD 180 000 - 210 000; Plein temps

Résumé du poste

Rentschler Biopharma SE seeks a Director of Quality Control - Analytics to lead the QC Analytics team, ensuring timely testing of samples and data integrity to support GMP manufacturing and product disposition. You will supervise a laboratory, manage OOS/OOT investigations, and drive continuous improvement while aligning with regulatory expectations.

The role requires 15+ years in GMP QC, 5+ years in management, and a chemistry/biochemistry life-science background.

Qualifications

• Bachelor's or Master's degree in Chemistry, Biochemistry or a related life science field.
• Extensive hands-on quality control and GMP experience preferred.
• Strong leadership, project management, and cross-functional collaboration skills.

Responsabilités

• Lead QC Analytics team and laboratory activities.
• Oversee investigations (OOS/OOT), deviations and CAPA within QC.
• Represent QC in audits and regulatory inspections; ensure data integrity.

Formation

Bachelor's or Master's degree in Chemistry or Biochemistry or related life science field

Description du poste

locationsMilford, MA, United Statestime typeVollzeitposted onVor 6 Tagen ausgeschriebenjob requisition idJR2850Advancing 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.Duties and ResponsibilitiesLeads QC Analytics team and laboratory activitiesHire and develop employees within the department, while setting clear expectations for successProvide active feedback, coaching and employee developmentParticipate in Milford Site Quality Leadership team meetings and follow up action plansCollaborate 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 inspectionsSupport the team in managing OOS/OOT investigations, deviations and change controls, and implementing appropriate CAPA as it relates to QCProvides representation in customer and authority audits and implementation of resulting corrective measuresResponsible 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 QCCollect and report quality control metrics via Quality Management Reviews and the Quality CouncilPromotes a strong Quality Culture based on the Rentschler core valuesQualificationsA Bachelor's or Master's degree in Chemistry, Biochemistry or a related life science field with substantial hands-on experience in Quality Control related activities15+ years of industry experience in a GMP QC environment, with a minimum of 5+ years of managerial and project management experienceLeadership skills to manage technical and laboratory personnelStrong 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.Working ConditionsNormal office working conditions: computer, phone, files, fax, copierPersonal Protective Equipment must be worn as requiredMinimum travel requiredWill interact with other peoplePhysical RequirementsPPE as required____________________________________________________________________________ Base Pay Range$180,000 - $210,000Disclosure StatementRentschler Biopharma, Inc is committed to fair and equitable compensation practices. The base pay range listed for this position is the anticipated annual base salary range the organization reasonably, and in good faith, expects to pay for this position at this time. Actual compensation is determined based on several factors that may include seniority, education, training, relevant experience, relevant certifications, geography of work location, job responsibilities, or other application factors permissible by law. The annual base salary is just one component of our Total Rewards package, which also includes our annual discretionary bonus program, medical insurance, our generous 401K program, plus a host of other benefits to aligned to support our employees’ personal and professional wellness. The salary pay range is subject to change and may be modified at any time.Brauchen Sie Hilfe?Wenn Sie Unterstützung beim Hochladen Ihrer Bewerbung brauchen, wenden Sie sich bitte an unser Recruiting-Team: [e-mail]