Job DescriptionJob Summary:
The Director of Quality Control (QC) - Microbiology is responsible for overseeing the Quality Control strategies and operations, including but not limited to testing function in support of the development and testing services of Phase I-III and Commercial Microbiological testing and Environmental Monitoring functions. The QC Microbiology Director assures compliance with GMP and company specifications as well as relevant pharmacopeia compendia. The Director identifies areas for continuous improvement and/or implementation of industry best practices and drives implementation in the laboratory. The Director keeps laboratory management informed of all departmental activities and product related events. Responsibilities:
- Provides technical supervision and leadership of teams that are assigned to perform environmental monitoring, product release testing, routine, and non-routine microbiological testing
- Collaborates with other departments to provide microbiology expertise and support for smooth running of GMP manufacturing operations
- Oversight and maintenance of quality control microbiological testing program (including bioburden, identifications and Environmental Monitoring, and outsourced sterility test laboratories)
- Participates and carries out continuous quality improvements in the QC laboratory
- identifies and resolves internal quality control microbiological testing issues
- Ensures compliance with cGMP and safety requirements within the QC microbiological laboratory
- Schedules and provides technical oversight of microbiological testing performed internally and externally sourced supporting GMP manufacturing and pre-Clinical activities and studies.
- Participates in project specific, system, client, and vendor audits
- 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 SOPs pertaining to Quality Control microbiological operations, STM's (standard test methods), and qualification and stability protocols (if needed) to insure appropriate codification of GMP procedures
- Ensures QC microbiological laboratories and facilities are always in an audit ready status.
- Serves as a back up to QC client rep in meetings for microbiological matters
- Acts as technical QC microbiological SME in support of client needs and projects and during third party inspections/audits.
- Interacts and communicates with customers to assure expectations are established, agreed to, and achieved.
- Engage actively with Project Management and other department functions to ensure the GMP programs are properly supported to achieve expectations; maintain effective and professional communication between all parties, including the customer.
- Identify, maintain, and report functional KPIs to site management.
- Bachelor's degree or equivalent experience
- 10+ years of relevant experience with 8+years of direct management experience
- Experience in Analytical or Microbiological testing including Environmental Monitoring required
- Auditing and compliance experience in a biopharmaceutical or clinical research organization and/or federal regulatory experience is strongly preferred.
- Experience in a GMP environment to include ICH guidelines, FDA guidelines, USP and EP, and other applicable regulatory guidance's (US and EU)
- Must be able to communicate effectively with others (both verbally and in writing)
- 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 (transversely collaborative) across functional groups and levels
- Creative individual with excellent problem solving and trouble shooting skills
- Ability to work effectively under pressure to meet deadlines
- Individual may be required sit for extended periods
- Be accessible to manufacturing floor and office staff and to use required office equipment
- Specific vision requirements include reading of written documents and frequent use of computer monitor