Quality Assurance Senior Manager

1 month ago

Cork, Ireland Hovione Full time

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.

- Guarantee cGMP compliance within the area, by assuring that all necessary procedures are implemented on the site, according to the products requirements and as established in specific Quality and Technical Agreements

- Manage teams and Team Members, ensuring the best organization of work to deliver on the key area objectives

- Manage complex cGMP programs

- Ensure the best structure, tools and prioritization to allow timely and quality release of products

- Ensure that plans are in place to regularly inspect the operational areas to verify compliance with cGMPs

- Lead clients and regulatory audits or inspections as required

- Manage and evaluate regularly data regarding the Key performance indicators established for the area, ensuring actions are taken whenever there are deviations

- Partner with the various areas to identify areas for improvement of how they work together

- Support a continuous improvement mind-set within the area to simplify and streamline how things are done within the area

- Assure that flexibility and simplicity are achieved through an entrepreneurship mind set and a “opt-in/opt-out” of procedures to meet the “fit for use” approach

- Approve complex IOPs, change control documents (PdAs), process and equipment related documentation as required

- 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 area strategic objectives

- Monitor Communication´s budget, by controlling budget 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:

- Master´s degree in Chemistry, Chemical Engineering, Pharmaceutical Sciences or similar scientific field

- Technical background preferred

- Typically requires 10 years of relevant experience within a Quality Assurance GMP environment within the Pharmaceutical Industry (mandatory)

- Preferably with previous experience (minimum 2 years) in operational areas such as Manufacturing, R&D or QC

- Proven experience in leading others in project context

- Effective time management skills and the ability to multitask.

- Track record of overachieving target

- Possess extensive knowledge of Quality, cGMPs, ICH and ISO guidelines principles and practices and is able to effectively share them with others

- Solid knowledge of Regulatory Affairs

- Good communication skills (verbal and written)

- Skilled at managing complex 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.

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