QC Microbiology Supervisor - 239599

We are a leading global contract development and manufacturing organization dedicated to the advancement of cell and gene therapy products. We believe in the transformative potential of cell and gene therapies and we are shaping the future of medicine.

Our company opens doors in the regenerative medicine industry for those looking to transform medicine while continuously improving an innovative, growing company.

Job Description

The Supervisor, QC Microbiology will organize and direct staff to meet and exceed cGMP requirements, establishing Key Performance Indicators (KPIs) while adhering to quality control-microbiological and technical standards.

The QC Environmental Monitoring Supervisor will also provide oversight of day-to-day activities including adjustment of workflow, test performance, and quality compliance.

Responsibilities

• Ensures compliance with regulatory agency requirements by enforcing a quality culture throughout the department.
• Schedules and monitors daily operation of department based on projected client demands.
• Conducts routine walkthroughs of the facility to ensure compliance with regulatory and quality practices.
• Approves investigations and documents non-confirming events and environmental excursions.
• Recommends process improvements to achieve greater efficiency within the department and between sites.
• Participates in department and cross-functional meetings.
• Maintains audit readiness within the department by ensuring proper training of staff, reviewing documentation, and ensuring laboratory cleanliness.
• Interacts with internal and external customers to ensure proper sampling, reporting, and resolution of questions and concerns.

Qualifications

• Bachelor's degree in Microbiology or relevant field.
• Minimum of 7 years of experience with environmental monitoring or within the biopharmaceutical industry or equivalent.
• Minimum of 2 years of experience in a supervisory or lead role.
• Strong knowledge of FDA and EU regulatory standards. cGMP experience required.
• Strong knowledge of microbiological test methods and philosophies.
• Strong knowledge of quality systems and ability to interpret Quality standards of implementation and review.
• Proficient with computer software with MS Office and LIMS (MODA experience preferred).

Competencies/Candidate Profile

• Collaboration, accountability, adaptability, can-do, leadership, technical capacity, problem-solving, customer-centric, communication, project management, and presentation skills.

Supervisory Responsibility

• Determines staffing levels; recruits, interviews, selects, hires, and employs appropriate number of employees.
• Provides oversight and direction to the employees in accordance with the organization's policies and procedures.
• Coaches, mentors, and develops staff, including overseeing new employee onboarding and providing career development planning and opportunities.
• Empowers employees to take responsibility for their jobs and goals.
• Delegates responsibility and holds staff accountable by providing regular feedback.
• Fosters teamwork and cohesiveness among department members; expeditiously initiates conflict resolution when issues arise.
• Creates a workplace culture that is consistent with the mission, vision, guiding principles, and values of the organization.
• Leads employees using a performance management and development processes to include goal setting, feedback, and performance development planning.
• Appropriately communicates organization information through department meetings, one-on-one meetings, appropriate email, and regular interpersonal communication.

Quality Requirements

• Builds Quality into all aspects of work by maintaining compliance to all quality requirements.
• Ensures compliance to all FDA and Worldwide Quality & Compliance regulations (as applicable to the job function).
• Attends all required Quality & Compliance training at the specified interval.

Direct Reports

QC Microbiology Analysts