Quality Assurance 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:

Guarantees cGMP compliance in all activities and systems related to Projects and Products execution. Assures that working practices are streamlined and aligned with the actual needs of each project. Implements policies, procedures and methods to evaluate and to continuously improve the quality of products and operations throughout the products lifecycle. Provides global supplier qualification services in support of new product introduction and existing products. Collaborates with suppliers and Procurement to assure the quality of their products, materials, components and/or operations.

 

- Rigorously, accurately, efficiently and professionally manage all quality activities for the assigned projects and / or products in accordance with applicable cGMP, quality operational standards / procedures and legal regulations, ensuring the site is always “audit ready”

- Promote the importance of high-quality levels and the importance of a continuous improvement culture in relevant company activities

- Act as a catalyst for change and improvement in performance/quality

- Assigned projects may relate to any of the following (non-exhaustive) areas: Raw Materials, Suppliers, Specifications, Production Processes, Change Control, Deviations, Quality agreements, Qualification and Validation, Stability Programs, Batch Release, Equipment Cleaning, Client Audits, Internal Audits, Customer Complaints, Customer requirements, PQR

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

- Efficiently, accurately and reliably ensure that project and / or product activities are delivered in compliance with cGMP requirements and maintenance of the company Quality Management System is assured

- Manage and participate in Quality Product key activities for the assigned product / projects, and introduction of new products; including (but not limited to) preparation, review and approval of auxiliary documentation, protocols and quality related reports

- To prepare for and support internal and external site audits and inspections, conducting regular reviews and periodically following-up action plans as necessary.

- Ensure inspection readiness in work completed and Act in an advisory capacity for all internal and external site audits

- Periodic follow-up of ongoing deviations and PdAs to assure timely closure of deviations and approval of PdAs, as appropriate

- To close open deviations and propose CAPAs based on the outcome of periodic follow-ups

- Prepares SOPs, department IOPs, quality related reports, revision of executed batch documentation and change control documents (PdAs) as required and appropriate

- Approves IOPs, process master documentation and product specifications as required and appropriate.

- Ensures that SOPs and IOPs are up to date, compliant and supports efficient production

- Review regulatory documentation and co-ordination of site documentation to support regulatory requirements

- Authorize the usage of production equipment/utilities when qualification required

- Solve challenges related to compliance problems by providing collaborative and timely support to all areas and departments, escalating as required

- Ensure the effective and proactive flow of information between stakeholders, representing the team as appropriate

- To assure and promote compliance on Health, Safety and Environment in the area and activities for which is responsible, or in which participates

- To maintain a regular presence on manufacturing floor, providing on-the-job support, developing a sense of collaboration with operational areas and performing a general oversight of activities, as required

- To approve Validation Master Plans, Process Validation Protocols and reports as required

- Accurately use and maintain all information systems

- Support the generation / reporting of KPIs for the team.

- Develop and accumulate strong QA expertise, sharing knowledge of new developments and methodologies within the area

- Co-ordinate and assist with the analysis and investigation of customer complaints that may arise; ensuring all complaints are investigated and closed out within specified timeframes

- To provide relevant training to new colleagues, and to the other areas in applicable cGMP, internal procedures and quality systems in accordance with established training plans

- Be an advocate for safe operating and high-quality performance, alerting ascending colleagues to any potential risks, discrepancies, deviations or non-conformance in accordance with Hovione internal procedures, suggesting optimizations or improvements

- Ensure all assigned tasks are planned and delivered on time, safely, efficiently, reliably and in a cost-effective manner

- Propose improvements to the area as appropriate and solve problems

- Make quality and timely decisions within the Quality Assurance tasks under her / his responsibility

- Gather relevant data to inform the decision makers regarding complex issues

- Execute professional activities in 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)

- Undertake any additional tasks commensurate with the role as and when required.

- 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:

- University, or equivalent, qualification in Chemistry, Chemical Engineering, Pharmaceutical Sciences or similar scientific field (mandatory)

- Typically requires 3-5 years of relevant experience in a QA GMP environment within the Pharmaceutical Industry (highly desirable)

- Experience of working in a GMP operational environment (mandatory)

- Training and experience of GMP standards (mandatory)

- Experience of working with Regulatory Affairs and a basic knowledge of the function (desirable)

- Strong understanding and knowledge of GMP practices

- Fluency in English is a requirement

- Computer literate with good working knowledge of the MS Office package

- Strong documentation skills and attention to detail

 

In compliance with the New Jersey Pay Transparency Act, Hovione discloses a base pay range for this U.S. based position. Actual pay is influenced by location, skills, experience, and qualifications. Non-exempt employees are eligible for overtime, and all roles may include a short-term incentive bonus. Employment is at-will, and compensation may change based on performance or market conditions. Benefits include 401(k), paid time off, leaves, and health coverage (medical, dental, vision), subject to plan terms. Full benefit details are shared upon offer.

 

Quality Assurance Specialist Compensation Range: $92,040- $147,264

 

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.