Oversee and manage the execution of Quality Systems (QS) at site level, including Nonconformances (NC), Corrective and Preventive Action (CAPA), Internal Audit (IA) Observations, Site Complaint Manufacturing Investigations, Product Quality Escalation, Quality Progress Review (QPR), Quality System Management Review (QSMR), and other assigned QS activities to ensure systems are effective and in compliance. Manage the performance and communication of QS metrics at site level. Ensure site readiness in the deployment of QS initiatives. Support compliance and document control areas, and continuous improvement of the Quality System. Responsibilities are for a site that is complex or has a demanding compliance profile
INTERPERSONAL SKILLS / CHARACTERISTICS
Interpersonal skills / characteristics:
• Strong communication, influencing and leadership skills: ability to communicate at all levels of the organization, and to interact with and influence cross-functional and cross-business teams to drive results is required
• Strong business acumen, interpersonal skills relating to teams with diverse cultures and business practices is required.
• Strong verbal and written communications skills for multi-level stakeholders
• Strategic and tactical execution abilities, including strong organization skills is required.
• Ability to take initiative regarding innovative approaches to problem solving in a fastpaced, changing business environment is required.
• Ability to apply principles of logical or scientific thinking, root cause and statistical analysis.
• Ability to analyze, graph, and present data in a way that facilitates and drives decision making.
• Strong verbal and written Presentation Skills
TECHNICAL MANAGEMENT RESPONSIBILITIES
- Responsible for the consistent and correct execution of QS procedures at the site to ensure the quality and compliance of processes and records for NC, CAPA, IA Observations, Site Complaint Manufacturing Investigations,
- Product Quality Escalation, QPR and QSMR, • Develops competency of resources at the site that execute NC, CAPA, IA Observations, Site Complaint Manufacturing Investigations, Product Quality LSYN_010253 V1.4 20/12/2018 Available in DE/ EN Page 2 of 4 Escalation, QPR and QSMR, by providing training and guidance on the execution and documentation of these processes,
- Responsible for the timely and compliant execution of site NCs, CAPA, IA Observations, Site Complaint Manufacturing Investigations, Product Quality Escalation, QPR and QSMR, by championing cross-collaboration across functions, sites, and operating companies; identifying barriers for the progress; and elevating issues for resolution,
- Manages on-site QPR and QSMR, including coordination, preparation, execution, and tracking of activities,
- Manages Product Quality Escalations for nonconformances or issues originating at the site, including the initiation, escalation, coordination, tracking, and closure of activities
- Manages on site the timely collection, escalation and reporting of all Quality System metrics to management
- Maintains original documentation for site NC, CAPA, IA Observations, Site Complaint
- Manufacturing Investigations, Product Quality Escalation, QPR and QSMR as quality records,
- Identifies site needs to meet and improve system performance of NC, CAPA, IA Observation, Site Complaint Manufacturing Investigation, Product Quality Escalation, QPR and QSMR at the site level, and escalates to appropriate representative and management in a timely manner,
- Collaborates with Franchise Quality in the deployment (design, implementation, and post-monitoring) of QS initiatives impacting the site that promote the continuous improvement of the QS and ensure continuity of the application of globally shared processes and systems at site level,
- Supports compliance activities by participating in audit readiness; assists in Internal and External audits; serves as Subject Matter Expert for NC, CAPA, IA Observation, Site Complaint Manufacturing Investigation, Product Quality Escalation, Document Control, QPR and QSMR processes during audits; manages the investigation, response, and remediation of site-specific QS audit observations
- Oversees on site Document Control (as required), including management of change documentation, on-site administration of the change control system, and archival of documents on site
MANAGEMENT & SUPERVISORY RESPONSIBILITIES
Job is directly responsible for managing other employees (e.g., hiring/termination and/or pay decisions, performance management).
EDUCATION & EXPERIENCE REQUIREMENTS
Degree in Engineering is preferred, or associated relevant Scientific / Technical / Quality discipline
• Six (6) years related experience in Medical Device or Pharmaceutical environment, or equivalent combination of education and experience is required
• Experience in working in a manufacturing / operations environment is preferred
• Knowledge of ISO and QSR regulations is required • Experience in Quality Auditing and notified body inspections is preferred • Experience with root cause investigation, change management, risk management and technical writing is required
• Experience in Quality Systems process development, support, integration or enhancement is preferred • Experience in Project Management is preferred
• A Certification in process excellence is preferred
• Advanced use of computer and software applications is required
• Experience with training or coaching others is required • Direct supervision experience is preferred
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