Director, Quality Control Technical Services
Rentschler Biopharma
Summary
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.
Job description
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 authorities' 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 expert 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
Requirements
- BS required in a scientific/technical discipline
- MS preferred in a scientific/technical discipline
- 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 expert in laboratory equipment qualification and data management
- Ability to apply GMP regulations and international guidelines
- Experience with regulatory inspections and client audits within startup/early phase and commercial QC laboratories
- Extensive experience with writing and managing investigations and risk assessments
- Proficient in MS Office application suite and GMP electronic applications such as LIMS
- Outstanding leadership abilities with analytical and critical thinking skills
- Proven leader, delegator, and decision maker
- Executive presence with strong interpersonal and communication skills
Benefits
- Annual Discretionary Bonus
- Medical Insurance
- 401(k) Program
- Professional Wellness Support
Company overview
Rentschler Biopharma is a leading global Contract Development and Manufacturing Organization (CDMO) specializing in biopharmaceutical services. Founded in 1872 and now in its fifth generation as a family-owned company, Rentschler Biopharma has over 50 years of experience in biopharmaceutical manufacturing. The company operates from two main sites: its headquarters in Laupheim, Germany, and a facility in Milford, Massachusetts, USA. With approximately 1,400 employees, Rentschler Biopharma offers comprehensive full-service solutions for bioprocess development and manufacturing of complex biopharmaceuticals, including analytical development, process development, formulation development, cGMP manufacturing, and regulatory affairs consulting. The company has an impressive track record, having contributed to nearly 25% of FDA-approved biopharmaceuticals in 2023 and serving over 180 clients worldwide since 1997. Rentschler Biopharma specializes in complex molecules, with more than 50% of their modalities being complex proteins including advanced antibody formats and recombinant enzymes. The company is known for its reliability, quality management systems, and operational excellence philosophy that ensures product quality and productivity at every development and manufacturing stage.