Product Quality Manager

Join a Market Leader:
Hovione is an independent family owned international group of companies. From the beginning, we have set ourselves above and apart through our innovative technological and productive capabilities, reaching a top spot in the world market as an integrated Contract Development and Manufacturing Company dedicated to helping Pharmaceutical Customers bring new and off-patent drugs to market.

Our people are the main asset for our continued success. Reaching over 1950 team members, from 36 different nationalities, that are located across Asia, Europe and North America (Portugal, US, Macao, Ireland, China, Hong Kong, Japan, India, and Switzerland), including 4 production sites.

Working at Hovione means reaching for innovation and excellence in everything we do: for our clients, our partners and, above all, our patients. That is why we are In it for life.

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.
- Manage complex projects and provide support to less experienced Team Members in their own projects
- Periodic follow-up of ongoing deviations and PdAs to assure timely closure of documentation
- Review PdAs and CAPAs and action plans to ensure a best in class approach has been taken
- Perform periodic follow-up of client audits action plans and client (or self) complaints
- Participate in Internal Audits and Supplier Audits
- Participate in client audits and health authority inspections
- Issue and follow up QA Department Deviation Records
- Deliver training in quality and cGMPs
- Identify deficiencies of the Quality System and pro-actively suggest/request improvements
- Handle clients’ quality related issues
- Prepare department IOPs and quality reports
- Participate in the planning, implementation, and certification of the Quality and HSE Management System
- Manage documentation control
- Approve change control documents and the respective implementation plan
- Approve qualification/validation documentation
- Participate in the creation of the activity plan and related budget for the Area in line with the unit's strategy, in order to align activities with area 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
- 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.
- Masters’ degree in Chemistry, Chemical Engineering, Pharmaceutical Sciences or similar scientific field
- Technical background preferred - Typically requires 5 years of relevant experience within a Quality Assurance GMP environment within the Pharmaceutical Industry (mandatory)
- Experience of working with Regulatory Affairs and a well-rounded knowledge of the function
- Experience in leading others in project context
- Effective time management skills and the ability to multitask.
- Track record of overachieving targets
- Possess solid knowledge of Quality, cGMPs, ICH and ISO guidelines and practices
- Good communication skills (verbal and written)
- Skilled at managing 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. At Hovione, that means a work environment where differences are valued, and everyone is treated with fairness and respect. We want all our team members worldwide to feel supported, respected, and have the opportunity to achieve their full potential, regardless of their age, gender, religion, disability, sexual orientation or ethnicity.