Managing Director Regulatory & Quality Affairs & Pharmacovigilance (m/f/d)

80331 München
03.07.2019

Daten dieser Anzeige

Job-ID: 010683787
Managing Director Regulatory & Quality Affairs & Pharmacovigilance (m/f/d)

via experteer GmbH

Germany

https://www.experteer.de/career/lp/signup_vertical_full_job/1_2018?job_id=18141840&affiliate=jobware_hh_feed_basic&utm_medium=metasearch&utm_source=jobware&utm_content=job&utm_campaign=jobwarehhfeedheadhunterbasic

Overall responsibility for leading the Regulatory including Pharmacovigilance & Quality Affairs functions Major Duties of Position Provides strategic leadership and coordination of RA, QA and Pharmacovigilance functions to ensure compliance with applicable law including all-time Audit/Inspection-Readiness as well as short-term and long-term company objectives Oversees the maintenance of product quality and compliance through the QA functions as well as the management of the Quality Management System and compliance processes with special focus on ensuring all-time Audit/Inspection-Readiness Manages local PV functions regarding compliance together with the EU/Global PV system and oversees adherence to local regulations Quality Drives the optimization and implementation of the Quality Management System (QMS) with the QA team. Ensures the QMS compliance with applicable legislation and guidance (global, EU, local) Ensures non-conformances (e.g. in the context of an internal audit) are investigated in due time and CAPAs are implemented Ensures a reliable connection of the local QMS with regional EU and global QMS Supports and leads the QA team to liaise with regulatory authorities regarding quality matters , including hosting inspections and responding to observations Regulatory: Oversees regulatory submissions Oversees labelling and marketing materials for compliance Proactively monitors upcoming and existing regulations, standards, policies, and guidance issued by relevant regulatory authorities for changes that may impact the company Pharmacovigilance: Monitors in-time communication, timely case report processing and oversees risks of products in close cooperation with the Graduated Plan Officer and the EU-QPPV Ensures timely and correct handling of safety-relevant information as well as timely notification to authorities (PV compliance) Oversees safety monitoring and benefit-risk evaluations including risk minimization measures Maintain thorough knowledge of all relevant PV SOPs, Good Pharmacovigilance Practice guidelines and relevant regulations Pharmaceutically required functions Ensures that the company has all legally required pharmaceutical roles filled with adequately trained personnel

Managing Director Regulatory & Quality Affairs & Pharmacovigilance (m/f/d) Standort: Großraum München Gehalt: vertraulich Job Description:Managing Director Regulatory & Quality Affairs & Pharmacovigilance** (m/f/d)** Description of Company As a subsidiary of a globally operating, Indian pharmaceutical group, the company benefits in the Munich area from the entire value chain. Development, production and marketing of excellent medicines are vertically integrated and in one hand. Focusing on R & D, the Group has a broad product portfolio with research & manufacturing facilities in many countries and exports to over 125 countries worldwide. Since 2011, the German branch in Munich has grown steadily and established itself in the generics segment. Through numerous cooperations with health insurance companies, a large number of products are available in pharmacies. The vertically integrated company draws on the Group's comprehensive and high-quality portfolio of indications in the fields of cardiovascular, diabetes, gastro, CNS, antibiotics and HIV. As a contractual partner of the statutory health insurance companies, the company helps to offer proven medicines and therapies affordable. Direct Reports 7 direct reports Primary Purpose of Position Overall responsibility for leading the Regulatory including Pharmacovigilance & Quality Affairs functions Major Duties of Position Provides strategic leadership and coordination of RA, QA and Pharmacovigilance functions to ensure compliance with applicable law including all-time Audit/Inspection-Readiness as well as short-term and long-term company objectives Oversees the maintenance of product quality and compliance through the QA functions as well as the management of the Quality Management System and compliance processes with special focus on ensuring all-time Audit/Inspection-Readiness Manages local PV functions regarding compliance together with the EU/Global PV system and oversees adherence to local regulations Quality Drives the optimization and implementation of the Quality Management System (QMS) with the QA team. Ensures the QMS compliance with applicable legislation and guidance (global, EU, local) Ensures non-conformances (e.g. in the context of an internal audit) are investigated in due time and CAPAs are implemented Ensures a reliable connection of the local QMS with regional EU and global QMS Supports and leads the QA team to liaise with regulatory authorities regarding quality matters , including hosting inspections and responding to observations Regulatory: Oversees regulatory submissions Oversees labelling and marketing materials for compliance Proactively monitors upcoming and existing regulations, standards, policies, and guidance issued by relevant regulatory authorities for changes that may impact the company Pharmacovigilance: Monitors in-time communication, timely case report processing and oversees risks of products in close cooperation with the Graduated Plan Officer and the EU-QPPV Ensures timely and correct handling of safety-relevant information as well as timely notification to authorities (PV compliance) Oversees safety monitoring and benefit-risk evaluations including risk minimization measures Maintain thorough knowledge of all relevant PV SOPs, Good Pharmacovigilance Practice guidelines and relevant regulations Pharmaceutically required functions Ensures that the company has all legally required pharmaceutical roles filled with adequately trained personnel Qualification Education Completed study of medicine, pharmacy or science Business Experience ·         More than 5 years' experience in a comparable position within the pharmaceutical business, preferentially in a generic company ·         Demonstrate exceptional PV-, RA- and QA-business understanding Languages German. English on international business level Personality ·         Self motivated energizing personality ·         Ability to prioritize according to compliance and business needs Management ·         Experienced in working a in an international matrix structure Leadership Excellent leadership abilities Remuneration Upon qualification. Jetzt bewerben

Pharma, Chemie, Med.-/ Biotechnologie

Projekt- und Produktmanagement/ Qualitätsmanagement

Medizinische Tätigkeiten/ Gesundheits-/ Sozialwesen

Chemie/ Pharma/ Biotechnologie

Bereichs-/ Abteilungs-/ Gruppenleitung

Vollzeit

80331 München