Pharmathen is one of the leading complex drug delivery and formulation developers and is among the top 50 pharmaceutical research companies in Europe. Driven by innovation, the company specializes in one of the most modern and technologically innovative sectors, developing Long Acting Injectables (LAI), Sustained Release formulations and Preservative Free Ophthalmics.
Pharmathen’s portfolio consists of over 100 products, produced at its facility in Sapes, Rodopi, approved by the US Food and Drug Administration (FDA), and at its modernized production unit in Pallini, Attica.
Pharmathen is one of the largest private investors in research and development in Greece, with steady investments of €35 million annually in the R&D sector and employs over 1,350 people from over 24 different nationalities. The company's enduring success is attributed to the passion for creativity, the ethics, and dedication of its people, who share the company's vision of making a difference in people’s lives.
Due to continuous growth and expansion, Pharmathen Pharmaceuticals offers a great opportunity for career development and is seeking to recruit a Health Authorities Inspection Readiness Lead for the Corporate Quality Management department at our Sapes, Northern Greece premises.
As a Health Authorities Inspection Readiness Lead you will be responsible for ensuring that the organization is fully prepared for inspections by regulatory health authorities (e.g., FDA, EMA) by leading inspection readiness activities, coordinating with cross-functional teams, and implementing strategies to maintain continuous compliance with regulatory standards.
More particularly:
What you will do:
- Develop and implement a comprehensive FDA inspection readiness program to ensure any time readiness for inspection
- Coordinate mock FDA audits and ensure corrective actions are implemented effectively and effectiveness check is monitored
- Maintain up-to-date knowledge of FDA regulations, current inspection trend and guidance
- Act as the primary contact for FDA inspections and coordinate all inspection activities
- Plan, conduct, and report on internal audits to ensure compliance with FDA regulations
- Monitor and ensure the closure of audit findings from authority inspection and non-conformances
- Perform gap assessment and regular review of all the products submitted/approved in US market
- Develop and deliver training programs on FDA regulations, inspection readiness, and compliance
- Ensure all employees are aware of and adhere to regulatory requirements
- Provide guidance and support to cross functions to ensure compliance to regulations
- Maintain a database of audit findings, corrective actions, and compliance metrics
- Prepare and present reports on the site’s compliance status to senior management
- Identify opportunities for improvement in the site’s quality systems and processes
- Implement best practices and continuous improvement initiatives to enhance compliance and efficiency
- Stay current with industry trends and regulatory changes to proactively address potential compliance issues
- Perform gap assessment with current regulatory inspection trend
- Work closely with departments such as Manufacturing, Quality Control, R&D, Tech transfer and Regulatory Affairs to ensure cohesive compliance efforts
- Follow Company's Quality Policy and comply with current operational standards and legislative requirements
- Work in accordance with the requirements of the written Policies, Standard Operating Procedures, Technical Directives and Protocols of the company's Quality System, that are related to the duties of the described position
- Follow the rules of hygiene and control of health status as defined in the relevant Policies and Standard Operating Procedures
Requirements
Minimum Qualifications
- Bachelor’s degree in a scientific discipline (e.g., Biology, Chemistry, Pharmacy) or related field
Minimum Experience
- Minimum of 5-7 years of experience in quality assurance or regulatory affairs within the pharmaceutical industry, with significant experience in FDA inspections
Job-Specific Skills
- In-depth understanding of FDA regulations and guidelines
- Experience with Good Manufacturing Practices (GMP) and other relevant regulatory requirements
- Excellent organizational and project management skillsS
- Strong analytical and problem-solving abilities
- Effective communication and interpersonal skills
- Ability to lead cross-functional teams and work collaboratively
- Proficient in Microsoft Office Suite and quality management software
- Strong leadership capabilities and ability to influence without direct authority
Benefits
What you'll gain:
- Involvement in a high-caliber, team-oriented and dynamic atmosphere
- Exposure to challenging business issues and practices
- Great opportunity to leverage and develop your business knowledge and skills
Join our team and experience the unique Pharmathen’s culture that gives you the opportunity to innovate, to make decisions, to achieve your own potential and to chart your own career.
Pharmathen is an equal opportunity employer. We welcome applications regardless of gender, race, age, religion, sexual orientation, and national origin.
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Last updated on Jul 3, 2024