Director, Quality Control - Analytics

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 Responsibilities 3Leads QC Analytics team and laboratory activities 3Hire and develop employees within the department, while setting clear expectations for success 3Provide active feedback, coaching and employee development 3Participate in Milford Site Quality Leadership team meetings and follow up action plans 3Collaborate 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 3Support the team in managing OOS/OOT investigations, deviations and change controls, and implementing appropriate CAPA as it relates to QC 3Provides representation in customer and authority audits and implementation of resulting corrective measures 3Responsible for supporting operational aspects of the QC Analytics laboratory, including data verification, PO management, records management, etc. 3Drives continuous improvement initiatives to enhance productivity and efficiency within QC 3Collect and report quality control metrics via Quality Management Reviews and the Quality Council 3Promotes a strong Quality Culture based on the Rentschler core values Qualifications 3A 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 315+ years of industry experience in a GMP QC environment, with a minimum of 5+ years of managerial and project management experience 3Leadership skills to manage technical and laboratory personnel 3Strong sense of accountability, self-motivation, and drive in meeting project objectives. 3Direct experience in managing and overseeing QC related activities internally and at third party vendors. 3Understanding of FDA/EU/ICH regulations and guidance related to critical quality attributes, release testing, analytical validation and transfer, and stability testing. 3Proven ability to lead and implement multiple projects/tasks simultaneously with competing and/or changing priorities ensuring effective time management. 3Excellent facilitation and project management skills, with strong verbal and written communication skills. 3Ability to effectively communicate across all levels and cross-functional teams. 3Ability to work independently as well as collaboratively in a team environment. Working Conditions 3Normal office working conditions: computer, phone, files, fax, copier 3Personal Protective Equipment must be worn as required 3Minimum travel required 3Will interact with other people Physical Requirements 3PPE as required ____________________________________________________________________________ Base Pay Range $180,000 - $210,000 Disclosure Statement Rentschler 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 employees92 personal and professional wellness. The salary pay range is subject to change and may be modified at any time.