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Corporate Quality Senior Manager

7 meses atrás

Lisbon, Portugal Hovione Tempo inteiro

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:

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.

- Assure the implementation of a Quality system (Project VMP, URSs, SOPs adoption, Q&V, Site Master File, QC)

- Participate in Conceptual, Basic and Detailed design review of the project in order to assure the GMP Compliance against applicable Guidelines

- Assure the application of QRM tools and methodologies for new standards

- Assure regulatory counseling during project implementation

- Review all documentation and be the quality representative in the discussion with INFARMED GARC and FDA CDER/OPQ

- Prepare and be the host of regulatory inspections (e.g. INFARMED)

- Evaluate the area resources needs (material and human) in line with Project strategy, vision and objectives

- Maintain active and efficient communication channels with Corporate Quality functions, operational areas and with project stakeholders in order to accomplish project goals, with a spirit of collaboration, and mutual help and support

- Promote the importance of a well-structured

- Risk based approach through the applicability of the appropriate tools and methodologies

- 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 DEPARTMENT 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:

- Masters’ degree in Chemistry, Chemical, Mechanical or Electrical Engineering, or related field

- Technical background preferred

- LEAN 6Sigma Green Belt certification preferred

- Typically requires 10 years of relevant experience, preferably in an operational area such as installation, qualification or maintenance of Facilities and Equipment and/or Quality Assurance;

- Proven experience in leading others in project context

- Effective time management skills and the ability to multitask.

- Track record of overachieving targets

- Possess extensive knowledge of Facilities and Equipment Qualification & Validation, cGMP and Data Integrity principles and practices and is able to effectively share them with others

- Understanding of Risk Assessment principles and tools, essentially applied to Qualification & Validation

- 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.