This role will lead and manage the strategic and operational performance of international quality and compliance department, ensuring the successful delivery of business strategy and objectives, whilst adhering to regulatory compliance and achieving commercial success.
The Head, International Market Quality & Compliance is responsible for multiple aspects of quality and compliance such as corporate auditing, supplier/subcontractors’ compliance status, batch release of third-party products, assessment of third-party change controls and deviations and as well complaints and has the overall responsibility on the supplier qualification program. The person is responsible for managing the compliance activities with nominated third parties and internal operating units, to ensure compliance with the Life Cycle Management of the Pharmaceutical products as defined by the corporate GMP Quality Policy and all relevant International regulatory and legislative requirements.
In addition, this position will be responsible for developing, implementing, and managing Pharmascience’s international quality system. This role is instrumental in managing the international release activities of the company, leading batch assessments to ensure releases are carried out efficiently, in a timely manner and meeting relevant regulatory standards. Contribute and collaborate in preparation of the regulatory files’ registrations, submissions to MoH and follow up the register procedure.
Responsibilities:
- Manages budget while maintaining efficient organization.
- Leads the quality and compliance activities with nominated third parties, to ensure compliance with the Life Cycle Management of the Pharmaceutical products as defined by the corporate GMP Quality Policy and all relevant Canadian & International regulatory and legislative requirements.
- Leads the TP quality management activities, the TP release activities and change controls of the organization, leading batch assessments to ensure releases are carried out efficiently, in a timely manner and meeting relevant regulatory standards.
- Leads the qualification program of TP suppliers and subcontractors from GMP & GDP perspective based on the international regulations following the corporate quality procedures. Approve any subcontracted activities which may impact on GMP & GDP regulations.
- Generates, evaluates, and acts on Third party strategic options and opportunities by using GMP compliance, business, and financial analysis. Defines division's plan and communicates frequently progress on achieving objectives.
- Verifies the GMP compliance status of all parties involved in global supply chains and that all sources are in accordance with the relevant marketing authorizations.
- Develops, supervises, monitors, and continually improves the quality risk management program (complaints, deviations, risk assessments) including policies and internal controls to ensure compliance with regulatory requirements and company objectives.
- Responsible for implementing, planning, executing, and maintaining the corporate external auditing program based on a risk and foster quality standards.
- Accountable for the deliverables of the qualification program (Quality Agreements, Licenses updates, Supplier/Service providers due diligence, External Audits).
- Approves Corporate subcontractors, customers, and suppliers from GMP & GDP perspective based on the international regulations following the corporate quality procedures. Approves any subcontracted activities which may impact on GMP & GDP regulations.
- Ensures that PIL’s quality management according to the system is implemented and maintained following the corporate quality system; Implements compliance program according to EU 2001/83/EC directive.
- Responsible for the quality and compliance activities in the regions of APAC, LATAM, PMS UKRAINE, MENA, Europe, and other international markets as required.
- Maintains Quality System/SOPs to ensure full compliance with Corporate Standards and current International & EU GMP/GDP practice. Implementation of the applied quality system in operations. To manage authorized activities and to ensure the accuracy and quality of records;
- Ensures compliance with all applications for new marketing authorizations, renewals and for variations concerning a change (addition or replacement) to the registered manufacturer(s) of the active substance, finished product or batch importation/certification sites.
- Acts as the company lead and liaison for Regulatory Agency inspections.
- Ensures that self-inspections are performed at appropriate regular intervals following a prearranged program and necessary corrective measures are put in place.
- Qualified Person ensures and certifies that each batch of medicinal product complies with the GMP guidelines and the marketing authorization or imported products. Reviews batch records for conformance to customer requirements. Communication with customers in resolving batch record concerns.
Skills, Knowledge & Abilities:
- Strong organizational, analytical and communication skills
- Excellent command of Greek & English languages, both verbal and written
- Experience working in a multicultural environment will be considered an asset
- Precision in execution of work with attention to details
- Strong ability to follow detailed processes and procedures
- Ability to work in a team environment
- Results orientation and efficiency driven
- Multitasking ability
- Deep knowledge of the manufacturing pharmaceutical process.
Experience:
- Minimum of 10 years of work experience in a pharmaceutical company.
- Registered & Certified EU Qualified Person
- Detailed knowledge of the current Canadian, International & EU GMP requirements
- Appropriate competence and experience Canadian, International & EU in GDP requirements
- Knowledge of the Pharmaceutical Legal Framework
- General knowledge of Eu Institutions Including the Agency
- Experience with audits and regulatory agency inspections
- Experience working with contract manufacturing/testing organizations.
