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Quality Site Leader


Jobref: IT CT 0014
Location: Catania
Salary: USD0.00 - USD0.00 per annum
Job Type: Permanent
Date Posted: Tue Oct 8 19:22:58 2019
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Description

The role of the site Quality Lead is to lead the Quality function for Catania and Medolla, Italy sites and reports directly to the Quality Operations MFA/API Leader/Sr. Director. The Direct Reports are: Quality Control Manager, Quality Assurance Manager, Validation Expert, Regulatory and Compliance Expert and Medolla site QP.

This function encompasses responsibility for Quality and Laboratory systems and ensuring that ICH Q10 compliant Quality Management systems are in place, in use and effective ensuring the sites are inspection ready. Quality Lead performs these activities in full respect and compliance to local laws and Regulatory directives and Company policies.

As Qualified Person (QP) is required to manage and implement Company Batch Release procedures in accordance with the relevant EC Directives including: 2001/82/EC, Annex 16 of the EU Guide to Good Manufacturing Practice, FDA CFR21, ICHQ7A, Reg. CE 183/05

This function is a member of the SLT (Site Leadership Team) and leads the SQRT (Site Quality Review Team), the Site Change Control and Recall Committees and fosters a culture of partnership and inclusion with other departments.

Key objectives of this position include:

Operationally, assures that QC operations in Catania, Medolla and third party contracted laboratories are ececuted in full compliance with Italian Laws, EHS and HR standards

Assures that each batch of products of the site and all relevant activities are manufactured and controlled in accordance under cGMP, Italian laws, Zoetis Quality Standards and within the Marketing Authorization requirements.

Inform the Italian BoH, or any other involved BoH and the API/MFA Quality Leader/Sr. Director of any relevant non-conformity of an animal health product already in the market.

Actively participates on audits performed by the US FDA, Italian BoH or any other BoH in accordancee with ICHQ1, ICH Q7a, EC Directives including 2001/82/EC and Annex 16 of the EU Guide to Good Manufacturing Practice.

Ensures to the Quality Operations Leader/Director that the Quality Systems are robust, effective and constantly compliant with regulatory requirements of all markets to which the site supplies products, to Global Regulatory requirements, cGMPs, Company policies, Italian/EU laws;

Assists the Quality Operations Leader/Director in the preparation of the Quality Operations Budget and ensure during the year that Capital /Operating Expenses and Headcount are maintained within budget;

Organizes the professional training plan of qualified personnel in line with Corporate policy;

Assures appropriate Succession planning and individual development plans for Quality Operation colleagues are actively managed.

Assesses product introductions to the sites and major capital projects to ensure appropriate Quality and Validation requirements

Provides Leadership and Direction for site wide and departmental continuous improvement initiatives, improved quality compliance a quality systems performance, and compliance with ICH Q10

This position achieves results through the leadership of colleagues with a direct reporting relationship to the API/MFA Quality Leader as well as a dotted line (indirect) reporting relationship to the Catania Site Leader. The successful candidate interact regularly with Catania and Medolla site leadership teams, the Quality Operations Center function and GQCA auditors, strategic sourcing, regulatory affairs, and the market (iCRAMs) to assure quality and regulatory goals and objectives are met.

Education

A Universitary degree in Chemistry, Chemical Engineeering, Pharmaceutical Technology, Biology or Microbiology, and a relavent advanced degree, MS or PhD is preferred

Experience

B.S. with 12 years experience, M.S., PhD, with 10 years experience, OR equivalent, in biological or pharmaceutical sciences, engineering, or related discipline. Including the following requirements: (a) a minimum of 5 years PROGRESSIVE experience in the quality assurance, manufacturing, quality control, or regulatory affairs function of veterinary or human or biological products. FDA-regulated environment is a must; a minimum of 5 years experience in significant management roles in a pharmaceutical or veterinary manufacturing environment; and a comprehensive knowledge of world-wide GMP requlations and expectations for the manfacture of APIs, Medicated Feeds and Pour-on parasiticides

Ability to develop and adhere to self-directed standard work. Strong people skills, leadership, communication and motivation including the ability to develop people and align colleagues (both intermal and external to the site) around common objectives and strategies.

Demonstrated written communication skills, as well as experience with presenting to leadership teams.

Must have strong technical/analytical and problem solving skills. Fluent in Italian and English

This is a Catania, Italy-based office position, This position will require fluent use of teleconferencing and Webex tools, Quality Sytems tools (Veeva Vault, PV Works, ETS and SAP as well as Sharepoint technologies, to share and manage information with GMS sites. A willingness to travel (15%) .

Zoetis is the leading animal health company, dedicated to supporting its customers and their businesses. Building on more than 60 years of experience in animal health, Zoetis discovers, develops, manufactures and markets veterinary vaccines and medicines, complemented by diagnostic products, genetic tests, biodevices and a range of services. Zoetis serves veterinarians, livestock producers and people who raise and care for farm and companion animals with sales of its products in more than 100 countries. In 2016, the company generated annual revenue of $4.9 billion with approximately 9,000 employees. For more information, visit www.zoetis.com