Operational Quality Manager, Serbia

Job Description

QA Manager, Serbia role will work with the International Quality to integrate Serbian requirements into the global Quality Management System. The role will act as the quality representative within Vertex Serbia and assume overall QA responsibilities for activities associated with the Serbian legal entity. Additionally, the role supports commercial activities related to GDP and GMP and will act as Deputy Responsible Person for Pharmacovigilance (RPPV) and serve as the Responsible Person (RP) for Regulatory Affairs acting as the authorised contact person to the Health Authority.

Key Responsibilities:

The responsibilities of this position may include, but are not limited to, the following:

• Act as the local quality representative/ QP for the Serbian market. Liaise with global Vertex QA partners on issue management and notifications to Health Authorities, as required.
• Support oversight for other markets/ countries as required.
• Proactively partner with other commercial departments to ensure quality aspects of new launches are properly handled. Set up effective collaborations with functional areas such as Regulatory, Supply Chain, regional/country manager.
• Responsible for the Quality oversight of activities at the distribution partner, including any repackaging/over-labelling, ensuring compliance with local requirements
• Provide guidance and monitor quality issues related to products and GDP to resolution within the company and with external parties.
• Raise and review documentation including change controls, deviations, CAPAs, SOPs and specifications relating to distribution activities. Provide training if required.
• Ensure Quality Technical Agreements are in place for all outsourced activities.
• Support recall operations for Vertex.
• Escalate quality issues to senior management as per Vertex procedures.
• Input into the International Quality Management review process.
• Work with the GDP Operational QA team to ensure the requirements of the Serbian guidelines are integrated into the global QMS. This will include:
  • Change Control
  • Deviation Management
  • Training, including training materials
  • Document Control, including SOPs, WIs, Site Master Files and forms
  • Risk Management
  • Management Review
  • Self-Inspection/Internal Audit
  • Vendor Management
  • Customer Qualification
  • Complaints, Returns, Falsified Medicines and Recalls
  • Regulatory Intelligence
  • Promotional Material and Healthcare Professional communications oversight.
• Ensure prompt and accurate response to cross-functional teams’ and vendor questions on a continuous basis.
• Collaborate and continuously build and foster relationships cross-functionally and on a global scale with individuals of all levels.
• Serve as Vertex’s appointed Deputy Person Responsible for Pharmacovigilance (RPPV) located in Serbia.
• Act as main contact to the local Health Authority for communications on regulatory submissions including initial applications and lifecycle activity.
• Provide support to the submission lead including by being the signatory of regulatory documentation.
• Performs other duties as assigned.

Key Requirements:

• Relevant degree
• A Qualified pharmacist responsible for the release of a medicine batch into the market in Serbia
• Strong knowledge and documentation of education in the field of Serbian pharmacovigilance regulations, standards, and best practices regarding safety processing and reporting, safety surveillance, and pharmaceutical industry compliance activities in the post-marketing approval setting
• Ability to travel internationally up to 10% of the time
• Knowledge of European GDP regulations; GMP and GVP regulations
• Ability to collaborate cross functionally across all levels of the organization
• Risk-based thinking and ability to work independently
• Technical writing
• Excellent communication and presentation skills in business English.

Flex Designation:

Hybrid-Eligible Or On-Site Eligible

Flex Eligibility Status:

Company Information

Vertex is a global biotechnology company that invests in scientific innovation.

Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at [email protected]