Quality and Compliance Specialist GMED
Locations: Diegem, Belgium
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Requisition ID: 1805704681W
Job Title: Quality and Compliance Specialist GMED
Division: GMED Quality Systems
Supervisor Title: QA manger
The Quality Compliance Specialist, is responsible for establishing and maintaining a robust Compliance Program for the GMED organization and performs quality duties including maintenance of the corrective action and preventive action (CAPA) and supplier systems as well as providing support for special quality projects. This program shall ensure that GMED is able to comply to local, national and international regulatory requirements, company policies and procedures and J&J corporate requirements. Further the Quality Compliance Specialist will act as the CAPA and NC Site Lead
This position will work with other J&J business to achieve Quality objectives
Duties and Responsibilities (essential functions)
* External inspection readiness and associated activities. Lead and manage site audit readiness activities to ensure inspection readiness at all time
* Prepare and support the hosting external audits in association with the site Quality Lead: e.g. Notified Body, Ministry of Health country inspections, FDA, J&J Corporate Audits for site. Responsible for effective regulatory agency inspections.
* Audit preparation activities (auditor logistics, front room/back room arrangements, identifying/preparing SME's, etc.).
* Assess the risk and applicability of audit observations from other J&J facilities to determine impact to the site
* Schedule and manage mock inspections as part of External Inspection Readiness activities.
* Provide timely information to support the inspection process, including those that maybe taking place at other sites / locations.
* Provide support to Quality leadership to generate daily inspection communications regarding potential non-conformities.
* Partner with Quality leadership to prepare responses to any external inspection or other regulatory notification associated with site.
* Internal Audit Program and Management Execution
* Establish and execute an effective internal audit schedule for site.
* Execute against established internal audit procedures
* Ensure adequate corrective actions for internal audits, including investigations and corrective action plans, drive on-time completion of CAPA plans, perform follow-up with CAPA owners, and perform effectiveness monitoring and closure
* Drive compliance and improvement in internal audit metrics
* Ensure quality system is periodically evaluated and audited and appropriate preventive/ corrective action is taken to meet the business and regulatory requirements
* Where appropriate, execute program(s) for training and evaluating qualifications of auditors. Note: Programs can include franchise, supply chain, sector, and/or enterprise elements.
* Enterprise / Sector Support
* Participate in JJRC audits as requested.
* Where appropriate assure representation on all required business unit, sector, and/or enterprise teams
* Support the creation and effective deployment of internal J&J Quality System and/or Compliance standards.
* Connect and collaborate with EMEA compliance team and other regions
* Lead CAPAs, NCs and Audit Observations
* Assure adequate corrective actions for external audit observations related to site, including investigations, monitor and drive on-time completion of CAPA plans, perform follow-up with CAPA owners, and perform effectiveness monitoring and closure
* Maintains quality records , nonconformance, project outcomes, and stakeholder input filed in an accurate and timely manner
* that required compliance-related events (e.g., field actions, inspections) are entered into EDGE per required timeframes.
* Assures that non-conformance investigations and quality systems are in compliance with the good manufacturing practices as established in the code of local government regulations and company procedures
* Lead on-going efforts to improve GMED Quality System where applicable.
* Support site lead for (WW) Quality system related improvement projects.
* Quality System
* Lead on-going efforts to improve GMED Quality System where applicable.
* Support site lead for (WW) Quality system related improvement projects
* Develop and implement appropriate Quality Procedures
* Refers extraordinary situations to the quality assurance manager for final approval.
* Assures effective change control.
* EDGE Reporting
* Assure that required compliance-related events (e.g., field actions, inspections) are entered into EDGE per required timeframes.
* Assure that EDGE information is current and updated in a timely manner
* Metrics Collection and Reporting
* Assure that Quality & Compliance metrics are consistently and accurately captured, and that metrics are captured at the appropriate level for subsequent analysis and reporting (e.g., site level, supply chain).
* Drive compliance to Quality and Compliance metric targets.
* Create reports and communicate performance against metrics to key stakeholders.
* Highlight/communicate adverse trends in metrics, and take risk based action to remediate.
* Escalate items in accordance with established procedures.
* Provide routine communication, updates and escalation to site and franchise organizational management regarding compliance trends and initiatives.
* Responsible for the proactive identification and alerting of management of quality issues in time to resolve potential adverse effects to the customer, company image/reputation and/or the business.
* External Standards and Regulations
* Support implementation of new external standards/regulations for GMED
* Maintain current knowledge of regulatory changes through industry publications, seminars, professional affiliations and industry meetings
Site Management Review
* Provide input into Site Management Reviews (e.g., internal audits, NC, CAPA) to allow meaningful review.
* Other tasks
* Proactively communicate organizational and compliance procedure/ policy related changes that may impact sites. Ensure feedback and alignment with said changes.
* Establish strong connection and collaboration with business partners at the site, e.g. Customer Service, Master Data
* Support and promote the safety and environmental objectives of the facility
* Partner with distribution centers and affiliates in the investigation/correction of process failures
Education and/or Experience
* 5-8 years related experience
* Internal/Lead Auditor Certification and/or extensive experience in executing audits
* Appropriate Engineering, Life Science, Physical Science or Business Degree.
* Six Sigma Green Belt or Black Belt certification or equivalent desirable.
* Demonstrated knowledge and application of Regulations and Standards (QSR 820, MDD, ISO13485) and other international standards.
Other Skills and Abilities
* Excellent written and verbal communication skills, with an open, collaborative, interactive leadership style, able to quickly build credibility within the Compliance and Quality community, executive management, external regulators, and industry.
* Ability to build and nurture strong and positive relationships with other leaders to partner effectively with Sector functions and across Operating Units
* Balanced technical understanding of products and processes combined with superior business and compliance acumen
* Accountability, with a strong desire to commit, be held accountable and be rewarded for delivering results with balanced decision-making
* Ability to recognize, build support for change and engage in constructive conflict using facts and rational arguments to influence and persuade
* High tolerance for ambiguity in a complex environment
* Ability to make the complex clear and easily understood by others
* Able to generate enthusiasm for best-in-class performance through the clear personal passion to be the best in these areas
* Capacity to put the customer central to all thinking
* Ability to discern critical issues amidst broad operating unit complexity and to engage and achieve executive management support for proactive and reactive measures
* Apply Credo values in an open and ethical manner and promote CREDO within the Quality and Compliance team.
* Working knowledge of Good Distribution Practice.