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Job Function:
Quality
Job Sub Function:
Customer/Commercial Quality
Job Category:
Professional
All Job Posting Locations:
Pefki, Attiki, Greece
Job Description:
J&J Innovative Medicine is recruiting for a Commercial Quality Specialist reporting to the Commercial Quality Cluster Head and to be based in Greece (Pefki).
Job summary
The Commercial Quality Specialist is responsible for the implementation and maintenance of the Quality Management System (QMS) for regulated activities in the Local Operating Company (pre- and post-marketing) and ensures, in collaboration with the various local/cluster leads of the regulated functions (e.g., Local Safety Officers, Head of Regulatory, etc.), compliance with the requirements of J&J Quality Policy as well those of the applicable global, regional and local regulations.
This function assures the quality and compliance of the product and services for the Greek Local Operating Company (LOC).
Job tasks and responsibilities
- Records in the dedicated electronic systems GxP related deviations, evaluates and participates in their investigation, establishes and follows the implementation of corrective/preventive actions. Verifies and analyses the results of the applied corrective/preventive actions.
- Promptly records received complaints in the dedicated electronic systems. Participates in complaint evaluations and investigation and ensures that all proper actions are undertaken for the complaint to be addressed in the shortest time possible, following local internal procedures and local legislation.
- Reviews the recordings related to environmental conditions for product storage and transport.
- Coordinates the local product recall process in an efficient and timely manner with all internal and external parties, as per dedicated procedures and regulations.
- Ensures that the methods and actions described in the product recall procedures are efficient (mock-up recall).
- Determines the product disposition for all returned/recalled products and communicates the decision related to the affected products.
- Coordinates the nonconform product destruction process.
- Supports all the actions needed for managing suspected falsified products.
- Ensures that all partners authorizations needed for performing distribution activities are valid and up to date, including the ones related to narcotic products.
- Participates in the selection, qualification and approval process for suppliers that provide GxP services.
- Participates in audits of service providers who offer GDP/GMP-related services, to ensure that quality standards are implemented and maintained and that the local legislation is respected.
- Prepares, updates and ensures that the planned internal audits and self-inspections are completed.
- Ensures applicable regional/global procedural documents are implemented in the local QMS and manages the local procedural documents.
- Ensures that training programs for induction and continuous trainings are in place, up-to-date and followed.
- Monitors, communicates and implements in the QMS applicable local/European legislation requirements.
- Documents and manages all the GxP changes in the dedicated electronic system.
- Supports the preparation of Quality System Management Review.
- Participates in quality-related local/regional projects.
- Ensures the implementation of all measures and compliance with the requirements regarding the serialization of medicines, according to the provisions of the European Directive 2011/62 / EU on counterfeit medicines and the Delegated Regulation 2016/161.
Main interactions:
- Internal: LOC functions (Supply Chain, Customer Service, Regulatory, Pharmacovigilance, Medical, IT, Finance etc) and global functions (Commercial Quality, manufacturing / release / distribution sites, etc)
- External: Health Authorities and other Regulatory Authorities, GDP relevant 3PLs and suppliers, clients and complainants, industry associations / organizations.
Other responsibilities
- Actively participates in regular regional meetings, provides solutions and supports the system improvement and implementation of any updates.
- Can be a Subject Matter Expert for a certain quality topic and can lead regional projects.
Basic competencies
- Fluency in both the local language and English is required.
- Ability to handle quality issues constructively, engaging relevant parties to ensure timely resolution and compliance.
- Strong capability to analyze complex data, identify key details, and summarize status updates and mitigation plans clearly.
- Demonstrates risk-based and fact-based decision-making, considering regulatory requirements, business objectives, and patient safety.
- Strong prioritization skills to meet deadlines and manage competing demands effectively.
- Ability to manage crisis situations calmly and efficiently, ensuring continuity and compliance.
- Proficient in using digital tools and systems, including quality management systems, Microsoft Office Suite (Excel, Word, PowerPoint, etc).
Job specific requirements
- University degree in Life Sciences, Pharmacy, Chemistry, Biotechnology, or related field.
- Previous experience in pharmaceutical or biotechnology industries, preferably in Quality Assurance, Compliance, Regulatory or process improvement methodologies.
- External Body Qualification/Certification as Internal Auditor is preferred. Additional certifications in Quality Management Systems (e.g., ISO 9001, GMP/GDP) are an advantage.
- Strong knowledge of GDP regulations, local legislation and industry quality standards.
- Familiarity with GxP principles and regulatory requirements for pharmaceutical distribution.
- Demonstrated experience in Quality Management and Project Management, including planning, execution, and monitoring of quality-related projects.
- Ability to lead cross-functional initiatives and drive continuous improvement.
- Capable of analytical thinking and summarizing key elements for decision-making.
- Strong root cause analysis and risk assessment skills.
- Computer literate with proficiency in Quality Management Systems (QMS) and Document Management Systems.
- Strong communication and stakeholder management skills.
- Ability to work independently and in a team environment under strict timelines.
- High attention to detail and commitment to compliance and patient safety.
Required Skills:
Quality Management System (QMS) Compliance
Preferred Skills:
Audit Management, Business Behavior, Coaching, Compliance Management, Continuous Improvement, Data Analysis, Detail-Oriented, Goal Attainment, Internal Controls, Issue Escalation, Problem Solving, Process Oriented, Quality Control (QC), Quality Management Systems (QMS), Quality Standards, Regulatory Environment