Senior Specialist, External Quality Assurance | Compliance and Data Integrity Center of Excellence
Merck
Weystrasse, Lucerne, Switzerland
vor 9 Std.

Job Description

Our Quality Assurance group ensures every single material inside our products is manufactured, processed, tested, packaged, stored and distributed aligned with our incredibly high standards of quality and meets all regulatory requirements.

Partnering across our internal manufacturing facilities, external contract manufacturers and suppliers we create an interdependent global manufacturing network dedicated to deliver a compliant, reliable supply to customers and patients on time, every time, across the globe.

Individual contributor responsible for ensuring the compliance of External Quality Assurance (EQA) processes against approved quality manual documents and / or ensuring robust business systems in compliance with our Company policies.

The Senior Specialist will be part of the EQA Compliance and Data Integrity Center of Excellence (CoE) within the EQA Compliance / System team, which will provide Quality oversight of Quality and Business processes with EQA and will also drive and / or participate in cross functional initiatives to develop and optimize Quality systems and business processes.

The successful candidate will be responsible for supporting the development, maintenance, and enhancement of critical processes and systems, and additionally, will be responsible for compiling, analyzing and reporting of associated metrics, supporting the development and implementation of strategic projects, as well as the development and ongoing monitoring of financial plans and performance.

The role ensures that Quality Systems and business processes are robust, effective and efficient to comply with required regulations, policies, and guidelines governing the manufacture of materials for our Company and may also be part of the team providing Quality oversight of internal inspection preparedness and performance of internal audits.

The Senior Specialist, EQA Compliance DI CoE could require routine interactions with all functions supporting the External Network, including interaction with functions across our global network.

Primary Responsibilities

Serves as Quality SME for EQA; Maintains and provides expertise on EQA quality and / or business systems, tools, data, and processes on an ongoing basis

Ensures that the organization operates within established policies / procedures of the Division and Corporation and complies with all applicable governmental regulations (GMP, etc) both domestic and foreign

Provides support to the organization to facilitate and implement new quality systems introductions and / or improvements

Assists with and / or lead the development, and ongoing execution of the Quality Systems

Establishes new or improved processes, tools, systems and drives consistent, standard business processes across EQA

Supports the compilation, analysis and reporting of metrics, including identification of trends and / or root cause(s) to help develop new initiatives and process improvements

  • Supports audit / inspection readiness of the organization and participates in regulatory and other quality and compliance report-outs;
  • review audit outcomes to ensure appropriate and timely corrective actions are implemented (where warranted)

    Provides project management support of EQA

    Assists in the preparation and coordination of Quality Senior Management presentations at management conferences, training programs, Quality Council, etc.

    Operates in a safe and efficient manner and in compliance with the Safety and Health Policy

    Education Minimum Requirements

    Degree in Science, Engineering or another relevant technical discipline (e.g. BS / MS Biology, Microbiology, Pharmacy, Chemistry, Chemical Engineering or equivalent preferred)

    Required Experienced and Skills

    Minimum three years prior experience in the Pharmaceutical / Biotechnology industry with a thorough knowledge of Quality Systems, Quality Assurance and Quality Control including solid knowledge of global GMP Quality and regulatory requirements

    Effective and positive interpersonal, communication, coaching, motivation, negotiation, and persuasion skills to build strategic relationships

    Audit / inspection readiness and management, quality agreement management, internal audits, data integrity SME, metrics reporting and / or Quality Council

    Ability to work across boundaries; demonstrated interpersonal, relationship building and leadership skills

    Effective verbal and written communications

    Preferred Experience and Skills

    Strategic and effective Project Management

    Quality Council Coordinator

    QSAT QUADS

    Supporting regulatory inspections.

    Conversant with all domestic and foreign regulations and compendia governing plant operations

    Our Manufacturing & Supply Division is dedicated to being the most trusted supplier of bio-pharmaceuticals worldwide. Our facilities, along with our external contractors, suppliers, and partners, create a reliable global manufacturing network that’s devoted to delivering a high quality, reliable supply to customers and patients on time, every time.

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