Senior HSE Compliance Specialist

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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:

Independent compliance function within HSE focused on the development and implementation of an internal audit methodology to monitor and report on management system capability and effectiveness.  Develops and maintains comprehensive knowledge and familiarity of regulatory and organization requirements and standards and assesses and reports on how requirements are being met. Supports regulatory audits and new license applications.

- Design and guarantee the implementation of an effective HSE Management System that is compliant with applicable regulatory requirements, company and site policies, operating procedures and standards.

- Define and monitor compliance with the HSE Management System requirements in the assigned areas, producing accurate statistical records and preparing and presenting KPI and performance reports on a periodic basis, to site leadership and Corporate HSE.

- Ensure an effective HSE documentation management system is in place and maintained in the assigned areas.

- Ensure risk management procedures and systems are in place, monitoring and reporting on the effectiveness of these procedures and systems.

- Manage the HSE Management System internal audit program in the assigned areas.

- Maintain and manage effective relationships with Corporate, external authorities, regulators, and the community in relation to HSE matters under responsibility; managing data submissions, licensing and applications as required.

- Oversee external audits, investigations and risk assessments as required, guaranteeing the prompt implementation of agreed upon recommended actions or corrective measures resultant from any audits or reports on the effectiveness of the HSE management and support systems in the assigned areas.

- Represent the assigned HSE areas in internal site meetings and engage stakeholders and areas to build effective working relationships.

- Keep abreast of new regulations and legal developments in the assigned fields of expertise, analyzing applicability to Hovione and advising of changes required as appropriate.

- Develop and accumulate strong HSE technical expertise in the assigned areas, sharing knowledge within the site to support HSE awareness and encourage a culture of compliance.

- Seek high performance standards for HSE in the assigned areas, identifying and driving opportunities for continuous HSE improvement.

- Provide an example of professionalism and support the induction and training of new colleagues within the area.

- Propose the definition of yearly plans and KPIs for the HSE assigned areas.

- Coordinate 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 superior approval the activity plan and related budget for the Area under responsibility in line with the unit's strategy, in order to align activities with HSE strategic objectives

- 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.

- To assure and promote compliance on Health, Safety, Environment and Sustainability, including the prevention of major accidents hazards, by exercising good governance and through the implementation of policy, procedures and training.

We are looking to recruit a Candidate:

- Master´s degree in Safety, Environmental Engineering, Science, or related field (desired)

- Technical background preferred

- Professional Certificate in Occupational Health and Safety at work (desired)

- Professional Certificate in Environmental Legislation (desired)

- Professional training certificate (desired)

- Typically requires 5 years of relevant experience in HSE management systems in a regulated industrial environment (mandatory)

- Strong practical experience of the operating principles and safety features of pharmaceutical processing technologies (mandatory)

- Experience in leading others in project context and a track record within a similar manufacturing environment (desired)

- Knowledge, Experience and Skills to monitor the Control of Major Accident Hazards.

- Effective time management skills and the ability to multitask.

- Track record of overachieving targets

- Possess solid knowledge of HSE management systems principles and practices

- Advanced knowledge of compliance needs in HSE

- Advanced knowledge and broad-based understanding of operations within a chemical / pharmaceutical manufacturing environment allied to a deep understanding of the risks posed by those operations to the safety of personnel and the environment.

- Must have the Knowledge, Experience and Skills to ensure that the requirements necessary for the Control of Major Accident Hazards are being fully implemented

- Strong awareness, knowledge and understanding of the HSE regulatory environment.

- Strong understanding of the operating principles and safety features of pharmaceutical processing technologies.

- Good communication skills (verbal and written)

- Skilled at managing processes and tools

- Fluency in English is a requirement

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.