Position Summary:
Develop, implement and ensure practical, innovative, sustainable, efficient quality systems and approaches. Lead team of quality engineers and validation engineers to provide guidance for investigations, recommend solutions using risk based techniques, and then perform testing protocols that verify the changes adequately mitigate identified risk. Drive reduction of the cost of poor quality through lower scrap rates, reduced rework, and more effective process control. Promote compliance improvement through education, strategic project initiatives, and organizing compliance activities.
Responsible for the management of validation activities, validation of site continuous improvement projects, and validation activities defined in the Site Master Validation Plan. Implementing continuous improvement activities associated with the validation program and owns the Validation Quality System as defined by site, regional and/or global procedures.
Primary Responsibilities:
- Lead the quality technical services department with accountability and responsibility for the validation group and quality engineering group, ensuring that each group has the technical and professional skills, organizational structure, capacity, and processes in place to maximize value.
- Manage departmental staff to ensure due dates are met. Coach and mentor, provide feedback, and work with employees to develop to their potential. Ensure teamwork is a priority and actively pursues strong engagement and collaboration with other departments.
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Provide Quality oversight and technical proficiency to owning departments including but not limited to:
- Maintenance – provide quality oversight for preventative maintenance content and documentation of planned and unplanned maintenance activity
- Calibration – provide support during OOT investigations, provide technical input for specifying instrument accuracy, precision, and tolerance ranges based on process knowledge
- Production – assist in root cause analysis for nonconformances and nonconforming material investigations
- Industrialization – Assess impact of formulary changes, evaluate proposed scientific study approaches according to identified process risk, and propose methods of leveraging data acquired from scientific studies to future studies or validations.
- Engineering – Craft a culture of knowledge sharing and collaboration and deploy acquired equipment functional knowledge and technical expertise for assisting investigations and proposing corrective and preventative actions
- Support inspection readiness through audit preparation initiatives and coordinating continual regulatory compliance improvement
- Advance compliance improvement projects that promote confidence in the site from regulatory authorities and ensures patient safety
- Promote quality training programs that provide necessary organizational knowledge to achieve company and regulatory objectives including compliance and validation
- Provide Quality input on manufacturing, quality control, and product development processes to maintain compliance with the relevant quality regulations and international standards.
- Identify critical process parameters to align with risk assessment mitigations and critical quality attributes
- Create and integrate a robust change management program for changes and review the scientific rationale for changes made. Train/Mentor other departments to adopt quality best practices and develop a quality mindset
- Responsible for ownership of the site validation master plan. Lead the site validation program including process, equipment, computer, and cleaning validation. Maintain compliance to current validation standards and current industry practices
- Incorporate risk based validation life cycle elements through continuous improvement of the Quality System.
- Ensure manufacturing equipment and processes remain in a validated state by trending process quality indicators and assessing cumulative equipment change over time.
- Maintain compliance with quality system, calibration and validation requirements for the St. Louis site; Implement key performance indicators / metrics to track performance.
- Support continuous improvement programs / projects.
- Ensure budgets, schedules, and department performance requirements are met.
Education, Skills, & Experience:
- Requires Bachelors Degree in a technical or science related field with a minimum of ten (10) years experience in a regulated industry with five (5) years’ experience in quality or validation work.
Five (5)+ years experience managing large groups is highly preferred.
Must possess thorough understanding of cGMPs, FDA validation requirements, ISO and MDSAP standards and regulations.
Requires excellent written and oral communication skills to interact across all levels of the organization.
Requires expert skillset of risk analysis, problem solving, statistical methods, and detail oriented technical writing.
Must have experience leading people, projects, and teams with the ability to work with limited supervision and to take initiative to ensure timely completion of tasks.
Extremely detail-oriented with strong organizational skills and high quality standards
Excellent relationship building and persuasion skills with the ability to motivate and influence others; demonstrated record of overcoming resistance to change, and driving the adoption of new processes from a position of indirect or informal authority
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