Director, Quality Control Technical Services

As a member of the QC leadership team in Milford, the Director, Quality Control Technical Services will manage and oversee a Quality Control team responsible for maintaining GxP systems and processes that support site business objectives; within QC this will be from Clinical Development to Clinical Supply and/or Commercial manufacture at a Contract Development & Manufacturing Organization (CDMO). The candidate will work in close collaboration with Manufacturing, Supply Operations, Process Sciences and Quality Assurance to support continual improvement and cGMP compliance. The Director will work functionally as well as part of a multi-disciplinary team to support the development and approval of our clinical development programs, commercial operations, and implement strategic imperatives within a fast-paced environment. Duties and Responsibilities Will manage teams of professionals within Quality Control encompassing raw materials testing, microbiology, QC LIMS master data and electronic systems, analytical equipment lifecycle management, documentation and data integrity Hire and develop employees within the department through coaching and mentorship while setting clear expectations for success Leads and manages the Milford Site QC Leadership team meetings and follow up action plans Establish and maintain Quality Control systems and processes at Milford, MA site Develops and maintains department budgets (expense and capital) in alignment with overall organizational goals for profitability Acts as portfolio manager for QC project work including scheduling, prioritizing and resource planning to ensure client contract deliverables are met Represents QC at the project team level and interacts with Rentschler clients as needed Ensure timely execution of client projects and clear communications to clients Identify and initiate improvements to Quality Control Systems and Standard Operating Procedures (SOPs), ensuring compliance with all relevant quality standards and regulatory requirements Verify & establish department readiness for audits by both internal and external authorities, serve as primary Quality Control contact for regulatory inspections and client audits Analyze regulatory authorities27 programs, guidance documents and activities in areas relevant to testing biological products Consistently advise site and Quality management of potential and actual actions that could adversely affect the business; represent quality exposures or represent opportunities to be pursued 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 Qualifications and Key Characteristics BS required, MS preferred in a scientific/technical discipline with 15+ years of experience in a QC position within the biological and/or CDMO industry 10+ years in a management/leadership role(s) PhD in a scientific/technical discipline a plus Experience in microbiological methods and contamination control Subject matter experiment in laboratory equipment qualification and data management Ability to apply GMP regulations and international guidelines to all aspects of the position Experience with regulatory inspections and client audits specifically within a startup/early phase and commercial QC laboratories Extensive experience with writing and managing investigations and risk assessments Proficient in MS Office application suite as well GMP electronic applications such as LIMS Outstanding leadership abilities with demonstrated analytical and critical thinking skills while managing high performing teams Proven leader, delegator, and decision maker with the ability to interact with all levels Executive presence with strong interpersonal and communication skills, verbal and written Working Conditions Manufacturing environment with potential chemical, electrical and physical hazards Personal protective equipment must be worn in the laboratories according to Rentschler safety requirements Exposure to cool/hot storage conditions May be working in a loud area at times, that requires hearing protection and other protective equipment to be worn Working around chemicals such as solvents, acids, bases and reactive or flammable materials May require immunization before performing work within the manufacturing area Pace may be fast and job completion demands may be high Some international travel (no more than 5% time) Physical Requirements May be required to stand for long periods of time while performing physical duties May be required to lift up to 10 lbs Must be able to work safely with materials and equipment PPE as required ____________________________________________________________________________ Base Pay Range $180,000 - $220,000 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 employees27 personal and professional wellness. The salary pay range is subject to change and may be modified at any time.