COMMERCIAL QUALITY AND SUPPORT SPECIALIST (1 YEAR CONTRACT WITH POSSIBLE EXTENSION)

The Commercial Quality (CQ) and Support Specialist is responsible for the quality of, and meeting the applicable requirements for, services and the products marketed by the Local Operating Company (LOC).
This function is responsible for compliance with the elements of the Johnson & Johnson Quality Policy and J&J Quality Management System that are applicable to the activities the LOC undertakes and ensuring that a quality management system of the LOC is implemented and maintained according to Commercial Quality Manual.
This function is acting as a back-up for Regulatory Affairs for Bulgaria.
Commercial Quality Activities/tasks 1.
   Implement, maintain and monitor the quality system for the LOC:  •        Ensure the provision of appropriate quality related training for regulated activities in the LOC.
•        Ensure appropriate management of non-conformances related to quality relevant GxP.
internal and external change controls, internal and external CAPAs, events, deviations.  •        Leading / coordinating for quality related auditing and inspection and report these and any other relevant field action activity into the relevant quality systems.
Ensuring that the LOC quality systems for the pharma commercial organisation are in constant state of readiness for planned and ad hoc audits or inspections.  •        Monitor quality system performance versus local quality relevant GxP and J&J requirements via use of pertinent business and compliance metrics and goals.
•        Provide the necessary input to the Quality Head for the bi-annual Management review for the LOC / SE Cluster.
•        Notify and engage SE Cluster Quality Head and Business Quality Regional and other affected stakeholders with any substantive concerns regarding product quality, safety and/or compliance, as per the Escalation procedures.
The  supports the SE Cluster Quality Head for escalations of the LOC.
•        Ensure suppliers in the LOC are qualified, have a quality agreement (where applicable) and are appropriately monitored against relevant company and local standards, if relevant.  •        Conduct regular self-inspections of quality relevant GxP practices that are applicable to the LOC activities.  •        Processing Product Quality Complaints (PQC) through relevant electronic systems, escalate critical product issues and conduct recalls and other field actions in a timely manner.
•    Collaborate effectively with various internal and external partners, such as the local Health Authorities, the Local Safety Officer, Regulatory Affairs, the manufacturing plant QA, CLS QA, the logistic department, other Cluster / LOC in EMEA and any other functions.
•        Proactively partner and support the LOC management team to ensure quality aspects in new product introduction and all other product portfolio lifecycle management processes, •        Monitoring and evaluating changes and proposed changes to country specific laws and regulations related to quality.
Keeping LOC Management and EMEA Business Quality structures informed about relevant changes and maintaining an updated record of applicable country specific laws, regulations, requirements and regulatory procedures related to quality.
•        Take care of lifecycle of BQ related documentation to ensure proper documents storage and archiving.
2.
   Designated as Controlled Substance Responsible Person and ensuring all relevant activities within the LOC are carried out in compliance with the specific requirements applicable to controlled substances.
3.
   Participate to Industry Association/Working Groups where present to anticipate, analyze current/emerging regulations/trends that impact Quality System, as appropriate.
Regulatory affairs •    Functions as Regulatory Affairs back-up in the absence of the Regulatory Head.
RMPs (Risk Management Plans)  •    Ensures administrative support for RMPs applicable for the LOC, including communication/approvals with BDA where relevant.
Qualifications •    Proficiency in Bulgarian and in English •    Degree level education preferably in a life sciences discipline; pharmacy degree is a strong advantage •    Attention to detail and capabilities related to flexibility, self-starting, critical thinking, and ability to prioritize •    Structured approach – able to manage complexity •    Accurate, timely, compliant work and task follow up •    Ethical behavior in line with J&J’s Credo values is required •    Knowledge of relevant pharmaceutical legislation, GMP / GDP, including any relevant legislation/guidelines relating to controlled substances is a strong advantage