Sr Program Manager Microbiology Quality & Sterility Assurance - Pharmaceutical

Sr Program Manager Microbiology Quality & Sterility Assurance - Pharmaceutical

You will establish and maintain the environmental control program and microbiology testing laboratory from onset of building and qualifying the facility leading to successful FDA approval of the facility and the ongoing introduction and approval of new medications. This newly created role will assure that the Environmental Control and Microbiology Sterility assurance programs comply with applicable regulatory standards (GMP, and FDA Guidance documents) for the development and reliable supply of quality medicines. Responsibilities also include, but are not limited to, the generation, review and/or approval of policies, procedures, reports, and other records necessary to support the design, implementation, and maintenance of a robust environmental control system and microbiology laboratory that meets or exceeds FDA requirements. Our finalist must live near or be willing to relocate to the Richmond, Virginia area.

Essential Duties and Responsibilities:

• Working across functions, lead the Environmental Monitoring (EM) and sterility assurance programs to enable the reliable supply of quality generic medications to patients.
• Design and establish microbiological testing laboratory.
• Develop and lead EM/microbiology/sterility assurance related quality systems activities including, but not limited to, aseptic process simulations (i.e., media fills) and environmental monitoring risk assessments and control plans, facility, utility, and isolator filling line qualifications, change control, CAPA, deviations and investigations.
• Develop and/or improve environmental control processes and systems.
• Develop programs and educate personnel on the importance of microbiological control.
• Identify, track and facilitate resolution of technical issues.
• Track, trend, and analyze EM and microbiology testing data for the site. Recommend action and continuous improvement plans. Summarize findings and recommendations for management and team awareness and/or present at routine Quality Council meetings.
• Participate or lead the assessment, qualification, and approval of suppliers.
• Proactively identify and work collaboratively to resolve problems taking risk-based and compliant approaches to solutions.
• Lead and maintain aseptic training program and sterility assurance risk assessments.
• Author and/or review and approve SOPs, protocols, reports and test method documents as applicable.
• Promote a quality mindset and quality excellence approach to all activities.
• Travel (up to 10%) may be required.

Basic Qualifications and Capabilities:

• Bachelor’s degree in a scientific discipline (microbiology degree preferred) with a minimum of 8 years Quality/CGMP management experience in the pharmaceutical industry. Experience in sterile injectable manufacturing, aseptic processing and facility qualification.
• Strong project management, organization, and execution skills with a proven track record of successfully managing multiple projects and priorities.
• Microbiology testing and environmental monitoring management experience across the product development and commercialization lifecycle including facility and utility qualification and ongoing monitoring in assuring a state of microbiological control.
• Participation and leading activities to support regulatory agency inspections required.
• Minimum of 2 years’ experience in a supervisory role highly desired.
• Excellent interpersonal and written communication skills and experience using various software/electronic applications required.
• Self-motivated, flexible, and able to work in a small, fast-paced, dynamic, environment.
• Ability to work autonomously and within established guidelines, procedures, and practices.
• Committed to delivering high quality results, working with others to overcome challenges, and focusing on what matters.
• Continuously looking for opportunities to learn, build skills and share knowledge with others.

Preferred Qualifications:

• Technical expertise in pharmaceutical and combination product process and isolator technology highly desirable.

The Senior Program Manager Microbiological Quality and Sterility Assurance will join this unique non profit pharmaceutical organization and its newly forming team near Richmond, Virginia by bringing your knowledge and experience in service to patients and pursuit of excellence in quality and compliance. This new site serves as the company's Fill Finish facility dedicated to the manufacture and supply of essential generic sterile injectable medications.