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Post Name – Associate Manager, Quality Complaint Management

Job ID: R232891


Job Description

Associate Manager, Quality Complaints Management


This position is responsible for executing Product Quality Complaint policy and guidance to assure product quality complaint management processes are in compliance with regulatory expectations.  Responsible for receipt and handling of product quality complaints.

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.

  • Manage routine product quality complaints and/or adverse events, including but not limited to:
  • Provide notification of product quality complaint(s) and/or adverse events to the External Partner (EP) and request investigation initiation
  • Coordinate investigation with EP site, to ensure due date and deliverables are met.
  • Coordinate complaint sample delivery to EP site
  • Review and approval of EP complaint investigation report
  • Enter investigation details in our complaint management system.
  • Coordinate supporting investigations with upstream sites as needed.
  • Routing and management of complaint record extensions as needed.
  • Issue escalation to the relevant Focus Factory Team members and/or Complaints CoE
  • Attend monthly EQA Complaints CoE meetings as required.
  • Trending of complaints by products and complaint category
  • Participate/provide support for audit/inspections related to complaint handling as appropriate.


  • A degree in science, engineering or any relevant technical discipline (BS biology, microbiology, pharmacy, chemistry, chemical engineering, or equivalent preferred).
  • Previous experience in the pharmaceutical industry with knowledge of Quality Systems and Quality Assurance including global GMP Quality Systems and regulatory requirements preferred.
  • Experience in pharmaceutical manufacturing of API/DS and/or oral solid dose and/or biologic/sterile products.
  • Previous experience managing product quality complaint and/or adverse event investigations.
  • Problem solving & continuous improvement mindset.
  • Ability to respond to non-standard requests from Internal stakeholders and External Partners; investigates with assistance from others as needed.
  • Ability to work across boundaries with both Internal stakeholders and External Partners
  • Communicates easily in English both verbally and in writing.
  • Knowledge of External Manufacturing management, supply chain, and operations (advantageous but not required)
  • Background in pharmacy / hospital setting / laboratory advantageous but not essential.
  • Background in manufacturing investigations e.g. deviations, out of specifications etc. (advantageous but not required)
  • Previous experience in pharmacovigilance (advantageous but not required)
  • Background in manufacturing investigations e.g. deviations, out of specifications etc. (advantageous but not required)
  • Previous experience in pharmacovigilance (advantageous but not required)

Our Human Health Division maintains a “patient first, profits later” ideology. The organization is comprised of sales, marketing, market access, digital analytics and commercial professionals who are passionate about their role in bringing our medicines to our customers worldwide.

Who we are …

We are known as Merck & Co., Inc., Rahway, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world’s most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.

What we look for …

We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.


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