Title: Associate Director, Microbiology & Sterility Assurance
Location: Asheville, NC
The Associate Director of Microbiology & Sterility Assurance is a key quality leadership role responsible for overseeing microbiological practices and ensuring compliance with regulatory standards in a manufacturing facility. This position plays a critical role in ensuring product safety and efficacy through rigorous microbiological testing, risk assessment, and contamination control. The role provides expertise and guidance in interpreting government regulations, industry guidelines, and internal requirements to maintain compliance.
Key Responsibilities:
- Develop and implement sterility assurance strategies, policies, and procedures for the manufacturing site.
- Establish and oversee microbiology programs, including environmental monitoring, microbial identification, and microbiological testing. Identify gaps, resolve discrepancies, and develop action plans to enhance compliance.
- Manage the microbiology laboratory, directing a team of professionals, prioritizing testing activities, and ensuring timely and accurate product release.
- Ensure adherence to regulatory requirements and industry standards, including FDA, EMA, PIC/S, USP, and ICH guidelines.
- Assess the impact of new regulations, implement necessary changes, and lead the development of process flows and procedures.
- Oversee sterile manufacturing operations, including cleanroom facilities, sterilization processes, and aseptic processing techniques.
- Provide direct leadership, including mentoring, performance management, and staffing decisions, for a large team of employees.
- Conduct risk assessments and root cause analyses for sterility assurance and microbiology-related issues, developing effective corrective and preventive actions.
- Foster strong collaboration with cross-functional teams, including manufacturing, quality control, and R&D, to ensure effective coordination of microbiology and sterility assurance activities.
- Participate in regulatory inspections and audits, responding to inquiries and observations from regulatory authorities.
- Manage departmental budgets, focusing on cost control and efficiency improvements.
- Stay informed of industry trends, emerging technologies, and best practices in sterility assurance and microbiology.
Qualifications & Experience:
- Bachelor's degree in microbiology, pharmacy, biology, or a related scientific field (Master's or PhD preferred).
- At least 10 years of experience in microbiology, sterility assurance, aseptic processing, or related fields in pharmaceutical or biotech manufacturing.
- Strong knowledge of regulatory requirements and industry standards for sterile manufacturing and aseptic processing.
- Expertise in microbiology-related regulations, including environmental monitoring, microbial identification, and microbiological testing.
- Proven leadership and team management skills, with the ability to develop and motivate teams to achieve goals.
- Strong analytical and problem-solving abilities, including experience conducting root cause analyses and implementing corrective and preventive actions.
- Excellent communication and interpersonal skills, with the ability to collaborate across teams and convey complex technical information effectively.
- Experience with regulatory inspections and audits is a plus.
This role is ideal for a microbiology and sterility assurance professional seeking an opportunity to lead critical quality functions within a regulated manufacturing environment. If this sounds of interest, please don't hesitate to apply!
