BioGX Hiring For Operations Manager, Molecular Diagnostics at Birmingham, AL, United States Full Time

Job Description

Purpose of the Position: This position supports the manufacture of In Vitro Diagnostics by implementing and/or improving processes so that Quality Management System (QMS) requirements are satisfied. This position is directly responsible for leading the Operations Support unit to success by planning, projecting and recommending resources needed to achieve Operations Support goals.

Essential Duties and Responsibilities (other duties may be assigned):

• Serve as the Process Owner for processes assigned by the BioGX Job Function Training Matrix and is responsible for the effective execution and relevancy of each documented process assigned.
• Oversee and on compliance to QMS requirements and process/personnel deficiencies for the Operations department.
• Make changes as needed to improve Manufacturing processes, product flow, compliance and personnel assignments within the Operations department.
• Promote success within` the Operations Support unit by communicating expectations; planning, monitoring, and appraising performance; coaching, counseling, and disciplining employees; implementing, coordinating, and enforcing systems, policies, and procedures.
• Manage processes within the Operations Support unit, including Receiving, Shipping, Labeling, and Infrastructure Management.
• Ensure compliance with international standards and all applicable regulatory requirements within the Operations department.
• Maintain Operations Support staffing levels by recruiting, interviewing, selecting, orienting, and training employees, and fostering professional growth opportunities.
• Ensure timely completion of Operations Support tasks by scheduling and assigning personnel; prioritizing efforts, monitoring progress, and resolving issues promptly.
• Ensure operational capacity by managing Calibration and Preventive Maintenance.
• Utilize process management/process improvement knowledge in solving problems associated with manufacture of molecular tests developed for diverse platforms.

Supervisory Responsibilities:

• Supervises all staff within the Operations Support unit. Qualifications: The requirements listed below are representative of the knowledge, skill, and/or ability required to satisfactorily perform the job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
• Project/Task Management experience
• Supervisory experience
• Performance Management experience
• Process Management experience
• Interdepartmental collaboration experience involving scientists, engineers, Quality Assurance and Regulatory Affairs, Product Delivery, Manufacturing, Sales & Marketing, and others.
• Working knowledge of cGMP and Quality Management Systems used in IVD products.
• Practical experience with clinical investigations during research, development, and validation stages in support of regulatory submissions (510k, PMA, IVDD/IVDR etc.).
• Firsthand experience with medical devices manufacture (and/or biotechnology pharmaceuticals with knowledge of IVD requirements)
• Possess the skills necessary to create and lead a culture of commitment to the values vital to organizational development and growth
• Willing to resolve problems
• Committed to developing and empowering others; to accomplish goals through the skills of persuasion, influence and negotiation
• Must have excellent communication skills (listening, written, verbal, presentation)
• Ability to interface and exchange information with all levels within the company’s workforce
• A team player that works to strive for continuous improvement
• Knowledge of bills of materials and other planning activities

Education and Experience: B.S. science or engineering or related discipline with at least 5 years supervisory Operations-related experience in an FDA/ISO regulated manufacturing environment.