QMS Manager at BioGX in Birmingham, AL
Purpose of the Position: Manages core processes of the Quality Management System (QMS) in accordance with international standards, regulatory requirements, customer requirements, and BioGX’s standard operating procedures herein referred to as “QMS requirements”. Uses discretion and independent judgment to fulfill essential duties & responsibilities outlined below.
Essential Duties and Responsibilities:
- 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.
- Responsible for assigned quality related activities within the organization, including but not limited to the maintenance of BioGX’s QMS, corrective action, preventive action, and process performance monitoring activities required to maintain compliance to QMS requirements.
- Manages document control for QMS related documents and procedure development processes in accordance with QMS requirements.
- Manages corrective and preventive action processes in accordance with QMS requirements including follow-ups through completion and effectiveness checks.
- Manages equipment management processes to include preventive maintenance and calibration activities in accordance with QMS requirements.
- Performs compliance monitoring activities to include atmospheric monitoring, material evaluation and acceptance monitoring, product evaluation and acceptance monitoring, receipt and dispositioning of nonconforming material/product monitoring, equipment qualification monitoring, material and product traceability monitoring, material and product identification monitoring, risk mitigation monitoring, supplier performance monitoring, product realization monitoring, record control including good documentation practices monitoring and other BioGX process monitoring as needed.
- Manages the reporting of QMS performance objectives and supporting activities. Participates in the regular review of quality objectives and identifies the need for corrective and preventive action.
- Manages QMS auditing processes and supporting activities.
- Monitors and reports on key performance indicators with regards to quality processes to identify the need for corrective and preventive action.
- Ensures that processes needed for the quality management system (QMS) are implemented and maintained in accordance with requirements. Develops and implements strategies to support/maintain compliance to QMS requirements.
- Alternative interface with FDA, Notified Bodies, and Alabama State Department of Health in the event of Company inspections. Work effectively across the organization to maintain a state of readiness for inspections by regulatory authorities and partners.
- Assists with risk management processes and supporting activities.
- Promotes the awareness of customer requirements. Echoes the importance of meeting customer, statutory and regulatory requirements.
- Brings together staff of different disciplines and drives the group to plan, formulate and agree on comprehensive quality procedures. Communicates with other company personnel to coordinate operations and activities.
- Other duties as assigned.
Directs and manages subordinate employees working within the department of Quality & Regulatory Affairs as assigned.
Qualifications: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- Excellent verbal and written communication skills.
- Interdisciplinary team building experience involving scientists, engineers, quality assurance, manufacturing, marketing and other participants in the medical device industry.
- Working knowledge of FDA’s QSR/cGMP, international standards, and Quality Assurance systems.
- Medical Device industry experience.
- Strong computer skills having advanced knowledge and experience with current word processing, spreadsheet, graphical, and file management software.
- Proficient in typing and keyboard topology.
- Extremely detail-oriented with strong organizational skills and high quality standards
Education and Experience:
Bachelor of Science Degree from a four-year accredited college or university; or five or more years related experience and/or training.
Language Skills: Must be proficient in writing, and communicating in the English language.
Mathematical Skills: Must be consistent with level of education.
Reasoning Ability: Good problem solving, judgment and decision making skills are required.
Physical Demands: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Work entails regularly performing tasks while working at a computer, desk, laboratory bench or automated machine. Work may involve occasional climbing or balance. Work entails occasional lifting and/or moving up to 25 pounds. Work occasionally requires travel between buildings. This is typically completed by foot or by car.
The employee’s sensory modalities (vision, hearing, smell) and physical capabilities (ambulation without mechanical assistance, strength, coordination, dexterity, range of motion) must be sufficient to independently perform duties/functions of the position.
Work Environment: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
This position will involve a combination of office and biotechnology laboratory environments. While performing the duties of this job, the employee may be exposed to hazardous chemicals, blood borne pathogens, automated equipment, and high levels of noise and vibration. The noise level in the work environment is usually moderate.
Job Type: Full-time
- Insurance: Health, Dental, Life, Disability and Vision
- 401(k) with matching
- Flexible spending account
- Paid time off