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EQA Product and Quality Leader (PQM)– API Platform - Ireland  

MSD (company)


Posted on : 04 June 2017

Project Description

  • Our company  is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. 
  • Today, we are building a new kind of healthcare company – one that is ready to help create a healthier future for all of us.
  • Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of an individual like you. 
  • To this end, we strive to create an environment of mutual respect, encouragement and teamwork.
  •  As part of our global team, you’ll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.
  • Our company  is currently seeking to recruit a Product Quality Manager (PQM) Lead to manage a global team of PQMs within the External Quality Assurance (EQA) API organisation. This position can be located in any of our Europe or Asia & Pacific countries. 
  • The successful candidate will possess a unique combination of analytical, scientific and business skills in order to effectively manage and control all activities necessary for support of a Quality Operations program to manufacture, test, package, store, and distribute, API intermediates and API’s.
  •  They will receive guidance on policy issues and direction with regard to operations, but function independently. 
  • The location of the role is flexible but is global in nature.
  • The position will report into the Executive Director External Quality Assurance – API. 
  • A strong technical background with a superior problem solving skill set, exceptional leadership abilities, strong knowledge of cGMP, product decisions and quality systems are considered essential, as these will be key attributes necessary to facilitate the ability to influence change in efforts to realize company’s vision.

Activities include:
  • Responsibility for oversight of Product Release from Contract Manufacturing Operations API/intermediates for External Parties (EP’s) with the assurance that the goods were produced in conformance to all applicable policies and procedures of  company and compliance with all governing regulations.
  •  Responsibility for oversight and management of Deviation, Investigations and Product Quality Complaints and ensuring appropriate escalation to ESQLs and EQA regional leaders for FF and SI.
  •  Supporting ESQL and regional leaders with data and information in preparation of significant investigation and fact finding.
  •  Management, tracking and reporting of all KPIs to support the API platform and ensuring effective execution of Quality Council meetings
  •  Identify and lead actions to drive improved and compliant processes/systems for EQA and Manufacturing Division improvements in processes and quality systems which support the platform.
  •  Incorporates strong risk management principles including special focus on data integrity and supports the end to end risk network risk management program (E2E) and the quality risk management (QRM) program.
  •  Ensures management of Annual Product Quality tracking and assembly.
  •  Ensure support of ESQLs, regional leaders within EQA API platform in the following processes:
    • Change control;
    • Document and records management
    •  Quality agreements
  • Ensure the PQM team effectively manages and executes on routine questions and documents requested by stakeholders from suppliers or vice versa.
  • Provides audit support for our company  internal and Regulatory agency audits and ensures appropriate and timely corrective actions are identified and implemented and manages any necessary gap remediation’s to the company EQA quality system.
  • Build and maintain strong relationship with external parties, operations, technology and procurement and global groups.
  • Competent in analyzing complex product, production and testing issues and have demonstrated scientific problem solving capabilities.
  • Possess strong compliance mindset, demonstrated interpersonal skills, including leadership and coaching, motivation and communication across a global team.
  • Responsible for transactional Quality Operations activities
  • Ability to speak up and raise issues and help to drive to resolution.
  • Ability to quickly adapt to changes and develop appropriate plans for managing risks.

  • BSc Biology, Microbiology, Pharmacy, Chemistry, Chemical Engineering (or equivalent) preferred.
  • Minimum of 6 years’ experience in the pharmaceutical industry including API experience with a thorough knowledge of Quality Systems, Quality Assurance and Quality Control including solid knowledge of global GMP and regulatory requirements.
  • Our employees are the key to our company’s success. 
  • We demonstrate our commitment to our employees by offering a competitive and valuable rewards program.Our Company’s benefits are designed to support the wide range of goals, needs and lifestyles of our employees, and many of the people that matter the most in their lives.

Travel: Yes, 15 % of the Time

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