Head of Alliance Quality

POSITION PURPOSE

Zentiva is a Pan-European Platform developing, manufacturing, and providing high-quality and affordable medicines to more than 100 million people in Europe. Zentiva has 4 wholly owned manufacturing sites and a broad network of external manufacturing partners to ensure supply security. We are offering solutions in key therapeutical areas like Cardiology & Circulation, diabetes, Oncology, Respiratory, CNS and focus on expanding our portfolio in self-care. The company is Private Equity owned, delivering sustainable double-digit growth, with an ambitious 5-year plan for further strong (organic and inorganic) growth across Europe.

We are a team of almost 5.000 unique talents that are bonded together by our common mission. We believe our diversity is a source of great energy and strength, and everyone should feel welcome, be able to be their true selves, and contribute to the best of their ability.

The Head of Alliance Quality provides effective leadership, ensuring compliance in processes at ESO / B2B level. The role addresses non-compliance oversees quality governance, and proactively ensures compliance with Zentiva and Health Authority GxP requirements. Core responsibilities include preventing issues that could impact product availability, approval delays, financial performance, and company reputation.

KEY RESPONSIBILITIES AND ACTIVITIES

• Support the definition of the quality direction and strategy for the Alliance Quality and assure its implementation and adherence within the department
• Support and assure appropriate quality oversight into processes and over CMO to ensure product quality and compliance of activities performed at CMOs for products delivered to Zentiva and its customers
• Lead and manage the Alliance Quality teams to ensure materials can be received, moved and shipped by supply chain on-time and in a compliant manner
• Lead a culture of compliance, articulating, role modeling, and providing leadership toward the desired culture and to drive a culture of continuous improvement, developing ESO and B2B quality across locations, building capabilities and facilitating Zentiva-wide knowledge and best-practice sharing across all facets of the operations (safety, quality, cost, service)
• Assure risk management and non-conformity management
• Assure implementation of basic QA processes within Alliance Quality team and continuously develop and ensure stable quality processes and support the harmonisation of these processes across Zentiva and assure creation of internal working instructions.
• Create transparency on quality performance, supporting target setting, KPI compilation and accurate monitoring of key external supply quality metrics
• Drive continuous quality improvement and achieve competitive quality costs, services and supplies and realize the objectives set in the ESO budget (Service Level, Cost, Quality and Resources) 
• Identify and address short- and long-term quality driven bottlenecks, closely collaborates with suppliers and markets to mitigate shortage risks
• Work collaboratively with cross functional teams to support product transfers and supply chain management activities.
• Assure organizational and operational Quality support to dedicated projects (e.g. market extensions and transversal projects set up).
• Manage budget connected to ESO Quality activities and successfully executes against the budget,  in particular: management of quality driven costs to maintain and improve existing external supply, and management of quality costs related to new launches and industrial projects
• Support finance team to drive the ESO budgeting and reporting activities relating to quality activities and costs
• Support supply chain to accurately set and maintain all quality master data and parameters
• Represent ESO Quality during audits and create a state of audit readiness and participate in and/or leading self-audits.
• Execute HR processes (staffing, development planning, talent assessment, performance management, succession planning, discipline, recognition).
• The employee will perform other tasks under the direction of the Manager within the agreed type of work

REQUIRED QUALIFICATIONS, EXPERIENCE &

• University degree in Pharmacy, Chemistry, Biology, or relevant Life Science
• Minimum of 10 years in similar role or top management in pharma company
• Extensive experience in management of External Suppliers (CMOs) / Site Quality within the pharmaceutical industry
• Expert knowledge of pharma quality, GMP processes, GMP regulations within quality system, cooperation with external subcontractors, internal and external audits and regulatory requirements.
• Proven leadership skills, including the ability to drive change and foster a culture of quality excellence.
• Experience in transformation, working in dynamic environment.
• Skilled in Communication (impactful, assertive, and persuasive)
• Flexibility and ability to manage competing priorities.
• Sense of urgency, high autonomy & stress resistance, agile personality
• Proven hands-on attitude, be flexible and adaptable, open minded.
• Possess strong change management, negotiation and influencing skills.
• Open minded, positive, and energetic person.
• Collaborative and team-spirited
• Advanced knowledge of English