This position is responsible for optimizing quality performance of assigned business areas.
• Serves as the Subject Matter Expert on the applicable quality systems for deviations management, change management and validation programs for US CSL Plasma.
• Responsible for utilizing failure analysis tools, such as Failure Mode Effects Analysis (FEMA) to investigate and assess risks associated with incidents or investigations, which warrant investigation.
• Responsible for maintaining or developing the systems necessary for effective Deviation Resolution, Corrective and Preventive Action (CAPA) and Change Control processes to support thequality systems improvements identified.
List current duties and responsibilities
Maintain a thorough understanding of the relevant regulations and guidelines: Food & Drug Administration (FDA), Clinical Laboratory Improvement Amendments (CLIA), current Good Manufacturing Practices (cGMP), corporate policies and procedures, FDA's guidance on Validations, all relevant Medical Device Directives, and other applicable standards.
Ensure compliance to and successful use of the Quality Systems for Change and Deviation Management. Conduct regular review of quality performance to ensure stable, high levels of compliance performance. Provide the routine KPI data for the management review quality systems metrics.
Utilize industry standard investigation, failure analysis, and corrective/preventative action tools when necessary to effectively investigate and respond to complaints, non-conformances or deviations.
Support the validation program improvements necessary to ensure compliance with FDA, German Health Authority (GHA), state and all other applicable regulatory requirements and best industry practices. Lead the verification and validation of new processes and products consistently meets user needs and specifications.
Effectively collaborate with other departments in designing and executing validation plans and protocols to minimize risk and impact. Plan, prepare and review validation activities and summary reports for team members and self. Assesses, verifies, or validates new processes and equipment to ensure that user needs and specifications are consistently met.
Participate in the maintenance of the company corporate calibration program. Ensure the Company meets regulatory requirements and industry wide best calibration practices at all locations.
Manage assigned projects effectively with an emphasis on multi-tasking and the ability to meet deadlines with quality results. May lead or participates on cross-functional teams to meet project and other deadlines.
Lead the change coordination and assist in the training program for Change Management. Collaborate with applicable business or quality departments to assure all process changes are entered into the system, analyzed for risk and impact, and that plans are executed and approved based on the risk and impact scope associated with the changes.
Collaborate with Learning and Development, Operations and Quality Colleagues and Business Technology teams to ensure change controls are implemented effectively, with appropriate dependences accounted for, appropriate training considerations communicated and documents updated appropriately. Maintain a strong understanding of the learning management system to support project and document change leads on the impact of changes.
Mentors others on data analysis, technical problem prevention and resolution, design control procedures, investigation processes and methods to arrive at true root causes. Assist in the training program for users of the CAPA process. Defines and controls the inputs into the CAPA system to improve the quality of root cause investigations and reduce the recurrence of quality issues due to the same or similar root causes.
Provide the technical writing oversight for department documents, validations and standard operating procedures for applicable change activities assigned.
Develop and facilitate training for use of the quality systems, including change management, deviation management and document controls.
Establishes and maintains a good rapport with all functional groups. Quickly engages with individuals involved in problems who need facilitation through to a successful resolution. Enables them to help themselves in future challenges through use of a disciplined approach to troubleshooting and documentation of steps taken.
Perform other job-related duties as assigned.
Provide minimum hiring requirements, specialized knowledge, and other considerations required
· Bachelor’s Degree in Sciences or Engineering or equivalent combination of education, training and relevant work experience required
· ASQ Certification preferred
· Minimum 5 years regulated environment required
· Minimum 2 years’ experience in a Quality role, preferably in a highly regulated industry
· In-depth working knowledge of cGMP principles and applications
· Demonstrated ability writing and approving documents, which help explain technologies, processes and products including validations
· Demonstrated ability to teach methods of analysis and written reporting to trained but not engineering staff
· Leading or participating in FMEA or RCA/CAPA development teams