Paragon Bioservices is a growing biotech Contract Development and Manufacturing Organization (CDMO) with an internationally recognized tradition of quality and service. Paragon Bioservices provides process development and GMP manufacturing services to industry leaders as well as innovative start-ups utilizing novel technologies to produce state-of-the-art vaccines and therapies for people when they are most in need. As a valued employee, you will actively contribute to the delivery of our services and products to our customers and their patients.
The Director, Quality Control will be responsible for overseeing and leading the Quality Control (QC) testing function in support of clinical/commercial manufacturing and ensuring compliance with applicable regulatory and industry standards for phase appropriate GMP manufacture of biological products.
Key responsibilities include but are not limited to:
- Oversight and maintenance of Paragon’s quality control testing program (including stability, reference standards and critical reagents)
- As a member of the Quality Control leadership team, participate in the Quality Metric review process, assess data for adverse trends, develop solutions and oversee implementation
- Identifies and resolves internal QC testing issues
- Ensures compliance with cGMP and safety requirements within the QC laboratory
- Schedules and provides technical oversight of testing performed internally and via external vendor labs supporting GMP manufacturing and Pre-Clinical activities and studies.
- Reviews and approves, SOP’s, Batch Records and protocols.
- Participates in internal audits of GMP QC data and records, monitoring files and study files. Reviews new and executed documents for compliance to stated Paragon SOPs, formats and regulatory requirements (especially protocols, deviations, investigations, amendments, etc.)
- Writes and/or reviews Paragon’s SOPs pertaining to Quality Control operations, STM’s (standard test methods), and qualification and stability protocols to insure appropriate codification of GCP/GLP procedures
- Provides strategic oversight and leadership to QC Client representatives to ensure project objectives are met to a high-quality standard and according to commitments
- Acts as technical QC SME in support of client needs and projects and during third party inspections/audits.
- Responsible for supervision of designated staff to ensure effective execution of roles and responsibilities
- Responsible for staffing and overseeing training, professional development of employees and conducting performance reviews within group
- Participate in facility expansion, coordinating QA support.
- Outlines objectives, identifying continuous improvement initiatives, monitors progress of deliverables, and provides support to Managers and Associates
- Serve as team leader in QC investigations and ensure corrective and/or preventive action plans to resolve potential product quality and compliance issues are appropriately implemented
- Continuous reviews of all systems and procedures (SOPs) for efficiency and regulatory compliance improvements.
Experience & Education:
- Bachelor or Master’s degree in science discipline with 10 years experience in analytical and/or microbiological testing of biologic products in a GMP environment
- 8+ years of direct management experience and demonstrated experience hiring and developing new teams
- Thorough knowledge of applicable GMP regulations, ICH guidelines, FDA guidelines, USP and EP, and other applicable regulatory guidances (US and EU).
- Strong focus on responsiveness, ability to multi-task, attention to detail, effective problem-solving skills, consistent follow-up and ability to make timely and sound decisions (Quality and Business). Must be able to prioritize.
- Must possess excellent communication and writing skills, patience, professionalism and ability to effectively interact with staff and management alike (transversally collaborative) across functional groups and levels.
- Advanced skills with MS Office applications and Adobe Acrobat
- Ability to analyze information and solve problems relating to Quality Control.
- LIMS experience preferred.