Corporate Quality Director

Join a Market Leader

About Hovione

 

At Hovione, we help partners turn scientific innovation into medicines that reach patients around the world. For more than 65 years, we have connected science, technology, and manufacturing to scale complex ideas into high-quality and innovative solutions that truly make a difference.

 

As an international Contract Development and Manufacturing Organization (CDMO), we support the development and manufacture of drug substances, intermediates, and drug products across the full life cycle. We are globally recognized for our leadership in specialized technologies such as Spray Drying and Continuous Tableting. But what truly sets us apart is not just what we do — it is how we do it: with purpose, care, collaboration, and a deep commitment to doing the right things right.

 

Our people are the reason for our success. We are a global and diverse team of more than 2,600 team members across Europe, the USA, and Asia, bringing together different experiences and perspectives to help our partners to overcome complex challenges. We believe that an inclusive environment — where everyone, regardless of background, identity or ability, is respected, heard and empowered to contribute — is essential to drive innovation, ensure quality, and secure long‑term sustainable success.

 

And as we grow, so do the opportunities for our people to develop, broaden their perspectives, and build meaningful careers. Because at Hovione, better starts with those who choose to make a difference every day. Will you be one of them?

You will be responsible to:

Implements and manages the required guidelines and cGMPs for Hovione, providing LEAN based Quality Systems and Tools, controlled, harmonized and aligned with the company’s strategic plan, promoting a rigorous and continuous improvement culture to guarantee high quality compliant sites. Maintains active and efficient communication channels along the several Hovione sites, identifying Quality needs and improvements both from internal and external stakeholders. Evaluates, advises and provides services and technical support, internally and externally, related to the legal and scientific regulatory requirements in relation to product development, commercialization and optimization across the full product lifecycle to ensure compliance with both global and local regulatory legislation, guidelines, inspections, audits and other regulatory due diligence. Represents Hovione through communications and negotiations with regulatory authorities, preparing, submitting and managing all matters related to regulatory submissions and licensing for Hovione and customer products; and within professional associations, industry/trade groups.

 

- Ensure that Hovione has an effective and efficient Quality System, with the right metrics, that is continuously updated for increased efficiency

- Establish regular Quality Performance oversight considering all key quality performance indicators related with Sites activities from development through commercial

- Ensure detection of global patterns related to Quality Performance Indicators, and foster knowledge, cross-functional interaction and the shift from re-active to pro-active behavior

- Regularly Measure and distribute the established Quality metrics transversally, along well described communication and escalation paths to have the adequate support from the operational level up to the Management Board

- Establish, in close collaboration with other Corporate/Quality Directors and VP Quality, milestones and KPI, to allow analysis and evaluation of results for continuous improvement of the Hovione Quality System

- Regular assessment of performance results, to identify the optimal strategic measures for a continuous improvement of the global Quality System (effective & efficient)

- Evaluate TOP5 data in each key indicator, to see reoccurrences, trends and discuss with the Sites the corrective and/or preventive actions to be implemented, as needed

- Support the Sites as needed in close connection with the Site Quality Directors

- Guide and set standards to manage the entire lifecycle of a product from concept creation through design and manufacture, until product/project discontinuation

- Be a key enabler for the Organization to develop and qualify consistent, repeatable processes that optimize resources, maximize profitability, improve product quality and minimize downtime

- Use Risk Management and Quality by Design (QbD) as principal guiding for strategic decisions and basis for validation activities, so that the Organization is able to capture, manage, report and mitigate risks throughout the product lifecycle

- Develop, implement and maintain a Corporate Quality system to manage Qualification and Validation activities (Equipment, Systems and Processes, including QbD and PAT), efficiently and effectively

- Improve interactions, operational mechanisms and key challenges within Sites Quality Assurance (QA) in the scope of QLCM

- Oversee and assure that all applicable guidelines and regulations are followed by Hovione’s Sites, as appropriate from each product development phase, commercial stage up to discontinuation

- Direct the QLCM Committee as Lead, assuring effective transversal interactions within Hovione’s sites

- Oversee the Validation status of Hovione’s Products/Systems during its lifecycle

- Monitor and regularly assess the results of product performance indicators to identify, analyze and discuss trends to act preventively and anticipate deviations, across its lifecycle

- Direct the approval and implementation of Qualification and Validation policies and procedures regarding Facilities, Equipment and Utilities and Computer Systems

- Participate with R&D in the implementation of innovative and modern technologies in order to comply with Customer and Regulatory expectations (e.g. Continuous Manufacturing and Real Time Release)

- Adapt Hovione’s Quality System to incorporate the new methodologies and be aligned with all involved parts, R&D, Customer and Regulatory Agencies

- Deliver training in QLCM matters

- Qualify Suppliers/Service Providers as per Purchasing policy and in response to outsourcing needs

- Execute internal audits and audits to suppliers with other Hovione members according the established plans, needs and the criticality of the audits

- Be present at Regulatory Inspections and Customers’ Audits for the matters under area responsibility

- Manage the TMs assigned to his/her area of responsibility, namely in terms of recruitment, integration, training needs and performance management in accordance with the company's HR policies, in order to ensure all TMs are aligned and motivated towards achieving Hovione's goals, values and culture by promoting their personal and professional development whilst maximizing productivity

- Develop and propose for approval the short and mid-term goals, annual budget and budget plan in line with the corporate strategy, in order to align activities with Hovione strategic objectives

- Prepare and propose for superior approval the annual area budget, by defining the allocation of resources necessary for the development of the activity, as well as ensuring the monitoring and control of its evolution, identifying any deviations between the real and the foreseen and taking corrective measures

- Ensure compliance with GMP and HSE guidelines, internal and external requirements as well as promote the implementation and maintenance of Hovione´s policies, systems and procedures (COPs, HBR, SOPs and others) within his/ her TMs

- Carry out assigned tasks and duties in a safe manner, in accordance with instructions, and to comply with environmental, health & safety rules/procedures, regulations and codes of practice.

We are looking to recruit a Candidate:

- Masters’ degree in Chemistry, Chemical Engineering, Pharmaceutical Sciences, or related field

- Technical background preferred

- Typically requires 10 years of relevant experience in API and/or Pharmaceutical Fine Chemistry and coordinating a team

- Proven leadership experience

- Effective time management skills and the ability to multitask

- Track record of overachieving targets

- Possess extensive knowledge of Quality, GMP, ICH guidelines and Regulatory Affairs principles and practices, and is able to lead others on them

- Good knowledge on Quality Risk Management tools and methodology

- Knowledge of LEAN and 6 Sigma concepts

- Good communication skills (verbal and written)

- Skilled at driving processes and tools

- Fluency in English is a requirement

- Must have the Knowledge, Experience and Skills to conduct their tasks in accordance with the rules and procedures set down.

 

Hovione is a proud Equal Opportunity Employer

 

Inclusion and diversity are key to us. We are committed to creating an inclusive recruitment experience and welcome applications from all qualified candidates. If you require any reasonable accommodation or support during the application or interview process, please contact us, and we will be happy to assist.

 

Notice to Agencies and Search Firms Representatives

 

Hovione does not accept unsolicited resumes from agencies or search firms for this job posting. Any resumes submitted to Hovione by a third-party agency or search firm without a valid written and signed search agreement will become the sole property of Hovione. No fees will be paid if a candidate is hired for this position as a result of an unsolicited referral.