Microbiology Manager

Summary of Position

The Manager Quality Control Microbiology is responsible for ensuring accountability, transparency, and effective communication cross-functionally and within his/her team while ensuring information is timely, clear and accurate. Coaching and developing will foster team ownership that ensures compliance with all policies, procedures and regulations. Must ensure maintain operational compliance with U.S. and international regulatory agencies (i.e. FDA, EU, ISO, USP, NRC, etc.) In addition, must supply the highest level of both internal and external customer service and measure and communicate the team’s progress against individual, team and site goals and Key Performance Indicators (KPI’s).

The Manager Quality Control Microbiology manages the activities of a dosage pharmaceutical quality control unit in the performance and analysis under GMP conditions for the entire site. Scope of responsibility includes raw material, in-process and finished goods testing and release as well as stability requirements for finished packaged goods. It also includes Environmental Monitoring of controlled environments to assure controlled environments are maintained.

Essential Functions

• Manage Quality Control laboratories: Microbiology/Environmental Monitoring.
• Ensure all necessary testing is carried out.
• Approve specifications, sampling instructions, test methods, procedures and other QC procedures.
• Approve and monitor any contract testing laboratory for compliance and test results.
• Ensure appropriate validations/qualifications are completed and approved.
• Ensure laboratory records are evaluated and signed by an authorized person before they are sent to the QA department.
• Ensure accountability, transparency, and effective communication cross-functionally and within the team while guaranteeing information is timely, clear and accurate.
• Coach and develop the team to team ownership.
• Ensure team compliance with all policies, procedures and site/company regulations.
• Set clear vision by ensuring goals and objectives are aligned with site strategies and managing each team member’s performance management.
• Exhibit accountability and responsibility for an area or process in order to affect change and lead efforts and ideas to completion.
• Provide leadership for employee relations through effective communications, coaching, training and development and eliminate roadblocks in order for the team to move forward.
• Supply the highest level of internal and external customer service while having the ability to diplomatically challenge established procedures and systems.
• Understand and provide education and feedback to team regarding business and financial impact of decisions/actions.
• Ensure all direct reports maintain ALARA and manage their daily activities accordingly to ensure they meet their quarterly ALARA goals.
• Ensure strong adherence to safety procedures.
• Ensure team meetings are held to update team and track progress.
• Lead team in continuous improvement activities.
• Ensure proper maintenance and cleanliness of the department, premises and equipment.
• Measure and communicate team’s progress against individual, team and site goals and Key Performance Indicators (KPI’s).
• Maintain an acceptable level of 5S in the area. Assure the laboratories are maintained to promote an organized workspace.
• Recognize and reward performance.
• Lead and/or support all investigations. Review and approve area quality and safety exceptions and investigation reports. Ensure on-time completion of investigations and corrective action items assigned to area.
• Verify, review and make appropriate changes if needed, to any controlled document pertinent to area of responsibility.
• Identify opportunities to reduce risk, reduce cost of poor quality and improve service.

Requirements

• Bachelor Degree in scientific discipline required or equivalent work experience.
• 12 or more years Quality Control relevant leadership experience, with two or more years of experience in a management role; (preferably managing a team of ten or more multi-shift employees).
• Aseptic GMP experience required
• Strong knowledge of cGMP requirements.
• Strong knowledge of laboratory equipment/product validation
• Complete understanding and application of principles, concepts, practices, and standards for testing performed in all QC laboratories through hands-on experience working in a Pharmaceutical manufacturing facility laboratory.
• Expertise in the manufacture and control of finished products, analytical analysis techniques and statistical quality control.
• Working knowledge of regulatory (FDA, EU, ISO, USP, etc) requirements and applicable testing Guidelines. Background must include analytical method validation work.
• Thorough understanding of Quality systems.
• Ability to use relevant software packages to process and analyze data.