Sr. Manager, QC Microbiology

Corden Pharma - A Full-Service CDMO• Boulder, CO, US, CO

6d•$145,000 - $165,000

About The Position

The Sr. Manager, QC Microbiology provides direct leadership and management for the Quality Control Microbiology Department in accordance with organizational policies and applicable laws and guidance. The role is responsible for developing employees, planning and directing work, meeting goals and performance standards, and driving continuous improvement. The manager promotes compliant efficiency, coaches technical staff, ensures high-quality technical work, and builds an industry-leading QC Microbiology laboratory. The position ensures Quality Control services are delivered with strong compliance and performance, that process and system boundaries are understood and followed, and that systems support the efficient flow of materials and services. It represents a high level of GMP understanding and accomplishment and monitors international and customer compliance expectations. The role recommends and implements improvements to quality systems and resource deployment, and works with Analytical Research to manage shared resources. The manager maintains Quality Control systems supporting the quality process, including laboratories, LIMS, SAP, inventory control, and SharePoint. The position provides microbiology expertise for environmental monitoring, GMP cleaning requirements for graded rooms, gowning, and water systems, and contributes to or creates contamination control strategies aligned with Annex 1 requirements. The role directly supervises 10 to 15 employees and is accountable for their development, performance management, and safe work practices.

Requirements

Bachelor's degree from a four-year college or university, more than 10 years of Pharmaceutical Microbiological Quality Control experience, or an equivalent combination of education and experience.
QC Microbiology laboratory experience, including commissioning of classified spaces and clean utilities, routine monitoring, release and stability testing, microbiological identification, and interpretation.
Demonstrated expertise in organizing, maintaining, and improving laboratory systems.
Strong understanding of microbiological concepts and ability to independently or collaboratively create microbiology programs.
Understanding of FDA guidelines, ISO standards, Annex 1, and other microbiology-related regulatory requirements.
Ability to analyze manufacturing requirements and translate them into strategies that can be articulated and implemented within the business.
Understanding of the basic science and engineering associated with pharmaceutical manufacturing.
Project management skills, including planning, staffing, organizing, directing, and controlling.
Analytical problem-solving skills and ability to lead or participate in risk assessments.
Strong written and verbal communication skills, including the ability to write reports and procedures and present information to managers, clients, customers, and the public.
Strong influencing, negotiation, leadership, coaching, mentoring, relationship-building, and motivation skills.
Ability to achieve results through positive direction of others and work closely with team members toward common goals.
Experience dealing with technical personnel at corporate and customer levels.
Strong computer skills, attention to detail, and math, reading, and comprehension skills.
Ability to interpret business periodicals, professional journals, technical procedures, and governmental regulations; write business correspondence and procedure manuals; and respond effectively to questions.
Ability to apply advanced mathematical concepts and statistical techniques, including sampling theory and analysis of variance.
Ability to solve practical problems with limited standardization and interpret written, oral, diagrammatic, or scheduled instructions.
Commitment to QHER Principles.
Ability to perform the essential functions described, with reasonable accommodations where applicable.

Responsibilities

Mentor and develop a team of microbiologists, manage QC Micro staff, and provide team members with coaching and development opportunities.
Monitor data quality and accuracy and maintain laboratory productivity by assessing workload and adjusting operations or staffing as needed.
Maintain laboratory equipment performance by establishing standards and procedures, ensuring staff compliance, certifying instrument performance, and arranging service, repair, or replacement.
Ensure routine QC Microbiology services are delivered accurately, efficiently, and economically, and drive continuous improvement in laboratory processes.
Benchmark and propose system improvements and resource deployment; use metrics and work plans to track and improve performance.
Serve as the QC Microbiology point of contact for internal and external customers and regulatory agencies, attend client meetings, and provide expertise on microbiological requirements for new and legacy structures.
Procure services and materials at optimum cost.
Maintain and improve QC compliance systems, including SOPs, calibrations, training, product approval, and release processes.
Work with the Analytical Research manager to use and manage shared resources.
Promote safe work practices among QC employees and properly manage hazardous and non-hazardous waste.
Monitor international regulations and implement systems to maintain compliance with changing requirements.
Provide microbiology expertise and guidance on microbiological principles, techniques, analytical methods, and associated equipment.
Create programs and procedures for environmental monitoring, contamination control, gowning, disinfectant efficacy and cleaning, and GMP water monitoring.
Assist with deviation investigations and CAPAs, gowning qualifications, and training others on microbiological concepts as needed.
Supervise employees, including interviewing, hiring, training, assigning and directing work, appraising performance, rewarding and disciplining employees, and resolving complaints and problems.