Site Quality Head - Bucharest

Site Quality Head
Bucureşti
Bucharest, Bucharest, Romania

The opportunity

Position responsibilities include Quality oversight for Manufacturing, Packaging and Laboratory Operations to ensure a mature culture of quality, compliance with regulatory requirements and quality of products.

This oversight includes but is not limited to: the establishment and execution of procedure; Establishment Licensing, Quality on the Floor activities including audit and release; handling of laboratory, deviation and complaint investigations; CAPA Creation and implementation; trending and metrics, compliance with validation requirements; verification that equipment, facility and utility systems are maintained in accordance with established requirements.

Lead the development, standardization, implementation, monitor effectiveness and continuous improvement of Quality Systems, global and local compliance programs, industry practices, and corporate quality initiatives. Influence quality and compliance initiatives to implement robust and proactive process improvement programs within a strong quality culture to align and demonstrate compliance to Good Manufacturing Practices.

How you’ll spend your day

Leads the Quality organization on site including Quality Control, Microbiology, Quality Compliance, Quality Systems and Quality Assurance Operations.

Ensure a current Quality Management System is in place and continuously improved

Ensure products are manufactured, released and distributed in accordance to c
GMP requirements and registered specifications.

Most senior professional and independent decision maker authority on product quality and potential market actions

Assess and Mitigate Risks - Identify quality risks and define proactive mitigations, to ensure the products are safe and effective before they reach the market. Work with the business to assure compliant and reliable supply

Design and Implement the Site Quality Program - Collaborate with the Site GM and Corporate Quality to create, implement, monitor and update the site quality program.

Manage Quality Data -Oversee the delivery of necessary data to site managers and supervisors, Corporate Quality and other internal and external stakeholders, to support the achievement of Quality objectives and ensure compliance

Direct Quality Control - Oversee the laboratory activity, including analytical site transfers, testing and approval or rejection of raw materials, packaging materials, in process materials and finished products for the site

Promote a Sustainable Culture of Quality -Create, develop and maintain a culture of enhancing quality throughout the entire site operation. Create a space where people can speak openly and are encouraged to present new ideas to improve quality

Maintain strong partnership with site leadership team

Strategic partner in the site leadership team, with Supply Chain, Project Management, R&D, MS&T and Commercial to ensure project timelines and objectives are met

Provide effective Quality leadership during internal, customer and Health Authority inspections

Ensure that Quality KPIs are meeting
- defined targets, Ensures CAPA commitments are implemented in a timely manner and its effectiveness is monitored periodically

Plans, manages and monitors the annual Quality Operations budget and all its resources and employees. Ensure the performance and utilization of resources to provide maximum efficiency to the organization.

Your experience and qualifications

Education

Required – Chemistry, Biology, Pharmacy

Preferred - Master or equivalent degree in Chemistry, Biology or Pharmacy

Key Requirements

Minimum of 10 years pharmaceutical manufacturing site quality operations and leadership experience, including: Deep knowledge of c
GMP requirements of local and major international authorities like EMA and US FDA for products and process, High level of understanding of manufacturing, packaging, technology transfer, c
GMPs, EU, ICH guidelines as well as CMC content of regulatory submissions, Deep knowledge of chemical/pharmaceutical production operations/ lifecycle, production equipment/ validation and relevant technologies and product types, Experience preparing and/ or leading regulatory authority GMP Deep knowledge of Quality Systems

Experience leading, inspiring and coaching large teams

Experience developing and implementing and continuously improve existing and new, efficient, and effective business processes

Must have adequate knowledge of Quality best practices

Must have adequate practical knowledge of pharmaceuticals manufacturing and/ or control

Must have adequate practical knowledge of analytical techniques and microbiological principles

Must have practical knowledge of pharmaceutical cross functional operations (e. g. , Supply Chain, Engineering), product and tech transfer

Must have practical knowledge on lean manufacturing/ lean QC and OPEX tools

Good knowledge of environmental, health and safety requirements for laboratories and quality operations.

The candidate should be able to delegate, well organized, should be able to adapt and lead change. International experience is desirable

Detalii privind locul de muncă:

Firma:	Teva Pharmaceuticals
Localiția:	Bucureşti Bucharest, Bucharest, Romania
Adăugat:	25. 1. 2025 Postul de muncă activ

Răspunde la anunț
Fii primul, care se va înregistra la oferta de muncă respectivă!

De ce să cauți de muncă pe Lucrezi.ro?

	În fiecare zi oferte noi de muncă
	Puteți alege dintr-o gamă largă de locuri de muncă: Scopul nostru este de a oferi o gamă cât mai largă de opțiuni
	Lasă să-ți fie trimise noile oferte prin e-mail
	Fii primul care răspunde la noile oferte de muncă
	Toate ofertele de muncă într-un singur loc (de la angajatori, agenții și alte portaluri)
	Toate serviciile pentru persoanele aflate în căutarea unui loc de muncă sunt gratuite
	Vă vom ajuta să găsiți un nou loc de muncă