Kelly Services is actively recruiting for a Quality Manager of CAPA and Management Review for a Direct Hire opportunity in Greater Chicago area, IL.
The CAPA and Management Review (CMR) Quality Manager is responsible for maintaining and leading the CAPA (including Deviation, Nonconformance) and Management Review activities and managing the programs for the Clients Schaumburg site. This manager must effectively work with quality, regulatory, operations, laboratories, purchasing, engineering, R&D, finance, suppliers and CMO’s to ensure that all events/excursions/issues are appropriately evaluated, investigated, risk and impact assessments are completed, action plans and effectiveness monitoring is defined, executed and closed in a timely and compliant manner. The CAPA and Management Review Manager ensures effective metrics, tracking and trending for the Management Review program and Quality System are defined and executed which meet regulatory requirements and expectations while applying industry best practices for data analysis and integrity, true quality system effectiveness measures, defining tolerances and metric criteria, goals, KPIs, and quality objectives which cover the totality of the Clients Quality System, roles and responsibilities, products and processes. This manager ensures the Clients management team is informed of negative trends, metrics/KPIs not meeting targets, risks to the quality system effectiveness and adequacy as well as ensures issues are escalated through the Management Review program. This manager ensures Clients implements appropriate controls, corrective and sustainable actions, monitoring, metrics, risk-mitigations and documentation is maintained for the CAPA and Management Review programs.
Key Job Responsibilities:
- Managing and maintaining the Clients CAPA (including Deviation and Nonconformance) and Management Review programs and assuring compliance with all applicable global regulatory requirements and standards for the Clients Quality System, all products and processes.
- Provide strategic and risk-based leadership in the execution of CAPA and Management Review activities ensuring compliance to procedures, specifications and Quality Agreements for Clients products, processes, roles, and responsibilities.
- Creating, executing, and approving Deviation, Nonconformance and CAPA investigations, evaluations, assessment against regulatory requirements/standards, risk assessments, procedures and change controls.
- Creating, monitoring, analyzing data, trends and metrics for the Quality System adequacy and effectiveness which encompass the totality of the Clients Quality Management System’s products, processes, departments, roles and responsibilities.
- Monitoring and coordinating resolution of failures/actions/changes required for issues from Operations, Quality, Regulatory, Purchasing, Suppliers/Vendors, Service Providers, Contract Manufacturing Organizations (CMO), and Distribution.
- Applying risk-based strategic planning for Clients related actions, internal mitigations and containment activities, testing and inspection for issues, compliance evaluations, gap assessment results as well as ensuring failures/changes are evaluated, documented and approved in a compliant manner.
- Developing and providing training on Root Cause Analysis (RCA), Deviations, Nonconconformance and CAPA management, execution, good documentation practices, application of sound scientific logic and compliance justification, impact and risk analysis associated with failures, negative trends and risks to product and process.
- Initiate, review, approve, lead and manage timely handling of deviations, CAPAs, effectiveness verification and associated changes (new or revised) to minimize impact to production, supply chain, transition, tech transfer or any improvement initiative as well as ensure appropriate handling of any failures/changes with potential impact on product quality, safety, efficacy and impact to the regulatory filing or quality agreement.
- Establish and maintain successful cross-functional relations with Design & Development, Engineering, Manufacturing, Operations, Quality Control, Quality Assurance, and Purchasing departments.
- Maintain governing procedures, forms and records for the CAPA and Management Review programs.
- Scheduling and coordinating the completion of the Site Management Review meetings, preparation activities, quorum attendees, data owner follow-up and responsibilities, creation/maintenance of the presentation and supporting data/trends, proposal of actions and metrics, verification of accuracy, robustness, data sources and effectiveness of the process monitoring and measurements.
- Serve as a Subject Matter Expert during Internal and External inspections, audits, assessments, and remediation activities.
- Manage Quality budget and quality staff.
Experience / Background / Skillset:
- Bachelor's Degree required, preferably in a Science or Engineering discipline.
- 10 years experience in the pharma or medical device regulated industry in Quality Assurance, CAPA and Management Review related functions.
- 5 years experience in management of direct resources or cross functional teams in a Quality System, CAPA and Management Review role.
- Experienced in FDA requirements, regulatory expectations and standards related to Quality Management Systems, CAPA, Life Cycle Management, Root Cause Analysis, Data Analysis, Data Integrity, Quality System effectiveness, Tracking and Trending as well as compliance remediation, project management, risk management and gap assessments.
- Experienced in application of, training and creation of cause analysis tools: 6M, 5Why, Fishbone, Cause & Effect, Is/Is Not etc.
- Experienced in data analysis techniques: raw data collection, pareto, statistical techniques, qualitative and quantitative data analysis and metrics, diagnostic analysis, data mining and converting raw data to meaningful metrics, trends to draw conclusions.
- Strong leadership skills to motivate and enable cross-functional personnel in meeting objectives, risk-based decision making, timeliness, personal accountability, product/process compliance and safety oriented.
- Strong written and verbal communication skills with effective documentation management skills and ability to communicate at all levels of the organization to drive timely and effective changes, status reports, resolution of issues, understanding of risks to the Quality System and the business.
- Experience in departmental budgeting and supervision/training/managing personnel.
- Strong ability to set goals and provide positive and constructive feedback respectfully to build positive relationships and improve results.
- Multi-tasks effectively, prioritizes and meets deadlines in timely manner.
- Strong organizational, planning, and follow-up skills and ability to hold others accountable by setting a strong leadership and compliance-minded example.
- Experienced, practical knowledge and application of the regulations and standards, (e.g. QSR, ISO13485, Quality System Requirements, CFR 211, 820, Part 11, ICH guidelines, Health Canada and Latin America regulations, FDA guidance documents), affecting Medical Device and Pharma manufacturing sites, Quality System life cycle management, CAPA programs, Data Integrity and Management Review.
- Demonstrated experience with development, implementation and management of quality system procedures and best practices which strong understanding of cause analysis, data analytics, metrics, process monitoring, CAPA and effectiveness verification.
- Proven ability to work successfully cross-functionally and collaboratively to problem solve, initiate and manage projects/changes, influence internal and external groups and provide leadership from a quality and compliance perspective.
- Proficient use of various software applications such as MS Teams, Word, Excel, Access, PowerPoint, Outlook and web-based applications.
If you feel you have the knowledge and expertise, apply today to connect with a Kelly professional who will work to enrich your life.
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