Emea Surgery Quality Pharma Operations Manager

il y a 7 jours

Erembodegem, Belgique BD Temps plein

**Job Description Summary**: Overview
- Ensure that the pharmaceutical products sold in the EMEA countries covered by the Infection Prevention business meet Quality requirements.
- Act as representative Surgery Quality Business partner to ensure product flow and compliance of all existing and new business to support the core EMEA Business and its expansion.

**Main Responsibilities**
- Manage the Business Unit Quality function in support of the Swiss Surgery Pharma Quality department. This encompasses Europe, as well as other country locations in EMEA where product is registered as a pharmaceutical.
- Establish the required EMEA Pharmaceutical Quality System to meet all compliance requirements in support of the Swiss Surgery Pharma Quality department. This encompasses Europe, as well as other country locations in EMEA.
- Recruit, retain, train, develop, manage, and lead the Quality talent in support of the Pharmaceutical Quality Management System (QMS).
- Liaise with the Swiss Surgery Pharma Quality team and EMEA Quality team to ensure that the existing Pharmaceutical Quality requirements are known and controlled in EMEA region.
- Provide timely support when requested by these organizations to support the preparation of necessary quality documents.
- Proactively follow-up on Quality issues to monitor impact in the field and ensure that they are addressed to the Associate Director, Global Pharma QP and RP in a timely manner.
- Escalate any significant Quality issues and provide leadership and direction regarding quality decisions.
- Provide Quality assessments on change controls / design control documentation (as needed) to ensure regulatory compliance with Quality requirements in EMEA Markets.
- Report on the performances of the Pharmaceutical Quality Management System, including any needs for improvement.
- Manage EMEA appointed Qualified Persons and act as their principal contact.
- Manage testing batch release setup for EMEA market (when appliable) including management of subcontracted laboratories directly or indirectly across the EMEA Region.
- Ensure GMP compliance of product intended for the EMEA market, including deviations and reworks when/if applicable.
- When/if applicable, ensure that sub-contracted pharmaceutical distributors and key entities with GMP/ GDP activities are regularly audited and are performing in accordance with corporate requirements.
- When requested by manufacturing divisions, launch, document and monitor product recalls and any other remedial field actions in the affected territories and closely follow-up on the timely closure of these actions.

**Duties/ Accountabilities**:

- Support QP to ensure Conditions of MIA (Manufacturing and Importation Authorisation) are met.
- Ensure compliance with GMP and GDP requirements.
- Keep up to date with the GMP and GDP requirements.
- Support the QP to ensure that the products are manufactured by registered manufacturer and in compliance with the specification.
- Ensuring QMS is operating satisfactorily.
- Perform gap analysis with the GMP and GDP requirements, as needed.
- Support routine self-inspection to confirm compliance.
- Oversee training programs for all personnel involved in GMP activities.

**Qualifications**

**Knowledge and Skills Requirements**
- Must have strong knowledge of global pharmaceutical regulations and industry notably in GMP and GDP.
- Language skills: Excellent written and oral English required.
- Ability to analyse Quality and Regulatory documents (e.g., Quality reports and Registration files) and implement requirements.
- Ability to read professional journals, technical procedures, or governmental regulations. Ability to write reports, registration modules and procedure manuals.
- Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public.
- Reasoning ability: Able to define problems, collect data, establish facts, and draw valid conclusions. Able to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.
- Other skills and abilities: Excellent verbal and written communication skills, strong negotiation and facilitation skills, and strong project coordination and management skills. Structured and largely self-organized.
- Manage departmental spending to the established budget(s) and lead departmental financial initiatives to effectively utilize allocated resources.

**Experience Requirements**
- Three to four years’ experience in Quality in an International organization.
- Healthcare/Pharmaceutical regulated environment or equivalent experience.
- Two or more years' experience in a management role.

**Primary Work Location**: BEL Erembodegem - Dorp 86

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