Site Quality Head (m/f)

Hemomont is a member of Hemofarm and STADA Group, one of the world’s largest generic pharmaceutical companies, successfully operating in the markets of Montenegro and the Western Balkans. Hemomont produces high- quality pharmaceutical products within the leading pharmacotherapeutic groups, adhering to key corporate values: Agility, Integrity, Entrepreneurship and ONE STADA.

Site Quality Head
Place of work: Podgorica

About the job:
The Site Quality Head is responsible for leading and maintaining an effective Pharmaceutical Quality System (PQS) to ensure product quality, patient safety, and full compliance with regulatory requirements.
The role ensures robust governance of sterile, non-sterile, and antibiotic manufacturing operations, including sterility assurance, contamination control, and cross-contamination prevention. The position also ensures sustained inspection readiness and drives a strong quality culture across the site.

Responsibilities:
  • Quality System Leadership
  • Lead and continuously improve the site Pharmaceutical Quality System (PQS) in line with EU GMP, ICH guidelines, and company standards
  • Ensure effective quality governance, management review, and continuous improvement
  • Promote a strong quality culture and compliance mindset across the organization
  • Sterility Assurance & Contamination Control
  • Ensure robust sterility assurance for sterile manufacturing processes
  • Own and maintain the site Contamination Control Strategy (CCS)
  • Oversee aseptic processes, including media fills (APS), interventions, and cleanroom practices Ensure effective environmental monitoring (EM) strategy, trending, and
  • response to excursions

Antibiotic Manufacturing & Cross-Contamination Control
  • Ensure appropriate controls to prevent cross-contamination in antibiotic manufacturing
  • Oversee containment strategies, facility segregation, and cleaning validation
  • Ensure risk-based assessment and control of carryover and contamination risks

Product Quality & Batch Release Governance
  • Ensure robust Quality oversight of all activities impacting product disposition
  • Provide risk-based recommendations and decision support for batch certification
  • Ensure timely escalation of critical quality issues
  • Note: Final batch certification remains the legal responsibility of the

Qualified Person (QP)
  • Deviations, Investigations & CAPA
  • Ensure effective management of deviations, investigations, and CAPA
  • Drive high-quality root cause analysis and sustainable corrective actions
  • Monitor trends and ensure prevention of recurrence

Quality Control Oversight
  • Lead the Quality Control function, including chemical and microbiological laboratories
  • Ensure compliance in testing, stability programs, and environmental monitoring
  • Oversee method transfer, validation, and laboratory data integrity

Data Integrity
  • Ensure implementation of Data Integrity principles (ALCOA+) across all systems
  • Oversee governance of computerized systems and audit trail review processes
  • Promote a culture of data transparency and reliability

Change Control, Validation & Lifecycle Management
  • Ensure robust change control processes protecting the validated state
  • Oversee validation lifecycle, including process validation and continued process verification
  • Ensure effective qualifications of facilities, utilities, and equipment

Supplier & External Quality Management
  • Ensure effective qualification and oversight of suppliers and contractors
  • Maintain quality agreements and supplier performance monitoring
  • Ensure risk-based audit programs

Inspection Readiness & Regulatory Interface
  • Ensure continuous inspection readiness
  • Lead Health Authority inspections and external audits
  • Oversee responses to regulatory observations and ensure timely closure of commitments
Leadership & Organization Development
  • Lead, develop, and retain a high-performing Quality organization
  • Ensure appropriate staffing, succession planning, and capability development
  • Promote cross-functional collaboration and accountability
Budget & Performance Management
  • Manage Quality budget and resource allocation
  • Define and monitor Quality KPIs aligned with compliance, product quality, and performance
Qualifications:
  • University degree in Pharmacy, Chemistry, Biotechnology, Engineering, or related field
  • Significant experience in pharmaceutical quality leadership roles
  • Advance level of English knowledge
  • Strong experience in sterile/aseptic manufacturing and GMP environments
  • Experience in managing antibiotic manufacturing or high-containment processes is an advantage
  • Proven track record in regulatory inspections and compliance management
  • Strong knowledge of GMP, Annex 1, and quality systems
  • Leadership and decision-making capability
  • Risk-based thinking and problem-solving
  • Strong communication and stakeholder management skills
  • High integrity and accountability
We offer:
  • Private healthcare insurance (with the option of privileged usage for fa mily member
  • Ongoing professional development through specialized education and t raining
  • A platform for learning 14 foreign languages, using various learning sty les, including conversation courses
  • Personalized mental health and wellbeing support for employees and t heir families through the Kyan Health app
  • New year bonus
Interested candidates may submit their applications via email at  Nemanja.d.petrovic@hemofarm.com or by using the KONKURIŠITE NA OGLAS option.
Only shortlisted candidates will be contacted.

* Prijavljivanje na oglas vrši se klikom na dugme "Konkurišite na oglas", na e-mail, poštansku adresu, e-mail adresu ili putem linka ukoliko su oni navedeni u tekstu oglasa. Prekoveze.me ne vrši postupak selekcije i odabir kandidata već je to u nadležnosti poslodavca. Odredbe ugovora o radu predstavljaju direktan dogovor između poslodavca i zaposlenog.