Job Title: QUALITY SYSTEMS MANAGER

Estimated Salary Range: $74,850.00 - $112,300.00 per year, depending on training, education, and experience. This position is eligible to participate in up to 20% of the company bonus pool.

Summary:

Evaluates processes, develops action plans, and coordinates the strategic implementation of system processes and corrective actions.

Primary Responsibilities for Role:

• Independent level of quality inspection and control - ensures center compliance with quality standards and regulations.
• Collaborates with Center Managers to ensure product quality, donor suitability and donor safety.
• Directs and monitors processes and ensures center compliance with all applicable state, federal, and company-designated regulations.
• Ensures that Standard Operating Procedures (SOPs) are properly interpreted, implemented in a timely fashion, and that the staff performs according to all SOPs.
• Interprets and implements processes, regulations and SOPs for quality control and overall regulatory compliance, making independent decisions and modifications as required.
• Oversight of all aspects of internal and external audits including execution (if applicable). This includes documentation, review of and preparation of the response. Also includes implementation of corrective and preventative action, assessment of corrective and preventative actions and follow-up as required.
• Continuously assesses, promotes, and improves the effectiveness of the quality systems in the donor center through recognition of trends, investigation of failures in the execution of procedures, direct employee observation and review of center documents.
• Responsible for the personnel functions of the Quality Systems Associate(s); including direction, assignment of work, hiring, development and training, disciplinary actions, termination, maintenance of all personnel records, management of work schedule and delegation/follow-up of tasks.
• Oversees product and biohazard waste shipments: Ensures shipments meet regulatory specifications and product release requirements; ensures accurate labeling and documentation; and, authorizes final shipment.
• Performs a review of the documentation of unsuitable test results and the disposition of the associated results.
• Works in collaboration with the Center Manager to develop the staff's knowledge of their job function and how their performance relates to the end product and patient.
• Documents, investigates, and performs root cause analysis for deviations and customer complaints, specifically in how they relate to the safety of the donor and the quality of the product.

Other Responsibilities for Role:

• Documents and tracks/trends center quality incidents and follows-up on incidents/errors as required; reports critical incidents and problematic trends to Center Manager.
• Reports compliance status to necessary parties.
• Ensures accuracy of donor files.
• Ensures that all supplies and materials ordered meet quality requirements prior to use and are stored in appropriate temperature/facility conditions at all times. Initiates appropriate investigations if these requirements are not met. Initiates rejection of supplies for non-conformance.
• Directs the maintenance and calibration of equipment and documentation of procedures.
• Ensures that Clinical Laboratory Improvement Amendments (CLIA) proficiency test surveys, complaint investigations, and training have been properly documented.
• Monitors training documents to ensure compliance with all applicable policies and procedures.
• Ensures that job and Current Good Manufacturing Practice (cGMP) training is completed, documented, and on file.
• Tracks/Trends and performs follow-up on corrective and preventative actions, system implementations, and process improvement plans to measure/determine effectiveness. Makes adjustments where required.
• Ensures that quality control (QC) checks are performed as required and are in acceptable ranges for test reagents.
• QM directs routine verification of the SOP and forms to ensure that they are up to date in the Donor Center's manual.
• Partners with the Center Manager to determine donor suitability activities and manages donor deferrals as appropriate.
• Prepares quality analysis reports to track issues and set goals. Does in depth research and analysis to resolve systemic compliance issues.
• Builds rapport with donors to ensure overall customer satisfaction with the Center to support long-term donation.
• Reviews and approves of deferred donor reinstatement activities.
• Performs a review of lookback information.
• Performs a review of medical incident reports and the applicable related documentation.

• Leads projects and initiatives for the region and division.

This job description is intended to present the general content and requirements for the performance of this job. The description is not to be construed as an exhaustive statement of duties, responsibilities, or requirements. Managers and supervisors may assign other duties as needed.

Job Requirements:

EDUCATION:

• Bachelor of Science degree or equivalent.
• Certified and proficient in quality and compliance.
• Works toward certification from American Society for Quality to be a Certified Quality Auditor.
• Works toward certification as a Designated Trainer for quality area is required.

EXPERIENCE:

• Typically requires 2-5 years of related WORK experience in a medical and/or cGMP regulated environment.

• Experience with plasma or whole blood.

EQUIVALENCY:

Depending on the area of assignment, directly related work experience or a combination of directly related education and experience and/or competencies may be considered in place of the stated requirements. Example: If a job level requires a bachelor's degree plus 4 years of experience, an equivalency could include 8 years of work experience, an associate degree with 6 years of work experience, or a master's degree with 2 years of work experience.

KNOWLEDGE, SKILLS & ABILITIES:

Command of interpersonal communication, organizational and problem-solving abilities. Ability to understand and assess FDA regulations. Strong integrity and commitment to quality and compliance. Full command of mathematics. Legible handwriting. High level of proficiency with computers. Proficient in root cause analysis and corrective/preventative actions. Ability to balance multiple competing priorities. Strong time management abilities. Proven ability to maintain a high level of quality and compliance and to become a valuable member of the center leadership team. Ability to work with minimal supervision. Ability to travel when needed for meetings, events, and occasional support of other centers.

OCCUPATIONAL DEMANDS:

Work is performed in an office and/or a laboratory/manufacturing environment. Exposure to biological fluids with potential exposure to infectious organisms. Exposure to electrical office equipment. Exposure to extreme cold below 32*, miscellaneous production Chemicals, moving machinery and production equipment. Exposure to high levels of noise on production floor. Personal protective equipment required such as protective eyewear, garments, and gloves. Frequently sits for 6-8 hours per day. Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists. Occasionally walks. Occasionally bends and twists neck. Light to moderate lifting and carrying objects with a maximum lift of 35lbs. Frequently drives to site locations with occasional travel within the United States. Able to communicate complex information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences. Works independently with little guidance or reliance on oral or written instructions and plans work schedules to meet goals. Frequently interacts with others, relates sensitive information to diverse groups. Must work with diverse groups to obtain consensus on issues. Ability to apply abstract principles to solve complex conceptual issues.

COMPENSATION AND BENEFITS:

The estimated pay scale for the Quality Systems Manager based in VAN NJYS, CA is $74,850.00 - $112,300.00 per year Additionally, the position is eligible to participate in up to 20% of the company bonus pool. We offer a wide variety of benefits including, but not limited to: Medical, Dental, Vision, PTO, paid holidays, tuition reimbursement and up to 5% 401(K) match. Final compensation packages will ultimately depend on education, experience, skillset, knowledge, where the role is performed, internal equity and market data.