Director, Quality Control - Analytics
Rentschler Biopharma
Summary
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 an 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.
Job description
Duties and 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
Qualifications
- 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.
Working Conditions
- Normal office working conditions: computer, phone, files, fax, copier
- Personal Protective Equipment must be worn as required
- Minimum travel required
- Will interact with other people
Physical Requirements
- PPE as required
Requirements
- Bachelor's or Master's degree in Chemistry, Biochemistry or a related life science field
- 15+ years of industry experience in a GMP QC environment
- 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
Benefits
- Annual discretionary bonus program
- Medical insurance
- 401(k) program
- Personal and 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.