Quality Control Microbiology Director
Dechra is a growing, global specialist within the world of veterinary pharmaceuticals. Our expertise is in the development, manufacture, marketing and sales of high quality products exclusively for veterinarians worldwide.
Here at Dechra, our values are embedded within our culture and thrive within our family of almost 2000 colleagues globally. From manufacturing to marketing, (D)edication, (E)njoyment, (C)ourage, (H)onesty, (R)elationships and (A)mbition are at the heart of our everyday operations and the way we do business.
- Leading and directing the Microbiology department, providing hands-on guidance and support to ensure the team is successful in meeting their objectives.
- Developing and implementing learning and development opportunities for team members to enhance their skills and abilities.
- Making informed quality decisions related to non-sterile and Aseptic Processing across various areas such as manufacturing, facility design, certification & maintenance, investigations, documentation, CAPA, change control, and regulatory compliance.
- Ensuring timely initiation and closure of documentation related to deviations & investigations, CAPAs, change controls, SOPs, with standardized supporting documentation.
- Establishing and enforcing effective SOPs and training documents to promote consistency and compliance within the team.
- Oversees execution of testing including routine lot related analysis, environmental monitoring and raw material testing. Generation and approval of certificates of analysis for product release.
- Leads development, implementation, enhancement and maintenance of QC Microbiology systems.
- Evaluating QC Microbiology systems and recommending and/or implementing system improvements and CAPEX projects.
- Responsible for the QC Microbiology and Aseptic Techniques Training programs.
- Conducting laboratory investigations and writing reports for deviations, Environmental Monitoring excursions, and Out of Specification results.
- Oversee the Environmental Monitoring Program, reviewing EM data, EM excursion investigations and EM reports.
- Ensuring that development and implementation of testing programs meet departmental, company, and regulatory compliance requirements.
- Taking ownership of multidepartment projects (identifying tasks, assigning responsibilities and timelines, and ensuring timely completion of projects).
- Developing effective partnerships with other departments to facilitate problem solving and resolution of issues.
- Coordinates with operations and supply management team for scheduling and test material availability to meet production demand and timely delivery of finished goods to distribution.
- Provides guidance to subordinates to achieve goals in accordance with established company goals and objectives.
- Develop and maintain internal KPI’s to demonstrate department performance.
- Writing/revising test methods and SOPs. Writing and reviewing QC technical protocols and reports.
- Develops, revises and reviews investigations, SOPs, qualification/validation protocols and reports
- Manage QC files and Environmental Monitoring electronic databases.
- Evaluate electronic database systems for implementation into QC.
- Effectively communicates with other departments and/or internal groups.
The Ideal Candidate
- Degree in Microbiology field with a minimum 5 years of cGMP QC Microbiology experience in a cell therapy/biotech/pharmaceutical setting is required.
- Excellent critical thinking and technical writing skills.
- Ability to work effectively and efficiently on independent tasks as well as to accept direction on given assignments or in a team environment.
- A minimum of 2 years of management experience including leading, motivating, and developing technical staff.
- 5 years Environmental Monitoring experience is required.
- Demonstrated ability to apply comprehensive understanding of QC guidelines, regulations, and current industry practices, including cGMPs and aseptic processing guidelines.
- GMP instrument qualification/validation experience.
- Experience with FDA cGMP manufacturing processes.
Dechra Pharmaceuticals PLC