Research Development Quality Inspection Management Lead (GCP/GVP)

Merck Group • $139K — $209K *
Billerica, MA 01821In-Person
Pharmaceuticals & Biotech
8 - 10 years of experience
3 weeks ago
Job Overview by Ladders

Qualifications

  • 8+ years quality assurance experience, with 5+ years in Clinical QA.
  • Bachelor's degree in a scientific field.
  • Experience with Regulatory Authority inspections (MHRA, FDA, EMA, PMDA).
  • In-depth knowledge of drug development processes and international regulations.
  • Broad understanding of GxP areas (GCP, GLP, GVP).
  • Ability to travel globally up to 20%.

Responsibilities

  • Coordinate preparation, execution, and close out of GCP/GVP inspections.
  • Host and support inspections as a team member.
  • Develop and implement proactive inspection readiness strategies.
  • Maintain controlled inspection processes worldwide.
  • Drive knowledge sharing and lessons learned post-inspections.
  • Provide timely reports on inspection status and CAPA completion.
  • Evaluate and maintain up-to-date inspection intelligence.

Benefits

  • Health insurance coverage.
  • Paid time off (PTO).
  • Retirement contributions.
  • Performance-based bonuses may be eligible.
Full Job Description
Your Role:

An exciting new opportunity has arisen to join the company's Global Inspection Management team as Inspection Management Lead. We are looking for a highly motivated individual with the ability to coordinate cross-functional and multicultural global teams. In this role you coordinate the preparation, execution and close out of GCP/ GVP Regulatory Authority Inspections of EMD Serono R&D projects or facilities. Responsibilities include the coordination of inspection setup activities and preparation of responses to inspection observations. You will also host or participate in inspections as a member of the Inspection Team.

You will also work on projects to continuously improve the inspection management processes and educate internal and external business partners on inspection management processes.

Location: This is a hybrid (3x/week) position based in Billerica, MA or Boston, MA. Onsite presence will be required at short notice to host inspections at both locations.

Key Accountabilities:
  • Coordinates the preparation, execution and close out all GCP/GVP Health Authority Inspections of R&D organization (hereafter referred to as Healthcare R&D) projects or facilities.
  • Hosts inspections and/or participates in inspections by providing full operational support to the respective inspection leads (Front Room, Back Room, etc.) .
  • Develops and oversees implementation and maintenance of proactive Inspection Readiness Strategies.
  • Maintains an effective and controlled inspection process within Healthcare R&D worldwide (e.g. global inspection standard etc.).
  • Establishes an effective and controlled inspection communication process within Healthcare R&D worldwide.
  • Drives active and regular knowledge sharing and lessons learned from previous inspections.
  • Provides regular and timely reports on overall inspection status, global response status and associated CAPA completion/close out, allowing for and contributing to state-of-the-art Quality Reporting.
  • Enforces the continuous evaluation of publicly available inspection reports/ information from various sources to proactively develop and maintain an up-to-date Inspection Intelligence, identifying potential new or upcoming issues of significance and to foresee/ confirm new inspection trends or expectations.
  • Develops and maintains standardized and harmonized tools for the preparation, conduct, reporting and follow-up of inspections.
  • Assists in developing the global quality strategy and implementing/ maintaining the associated Quality Management System.
  • Participates in special assignments on various project teams and work streams as determined by RDQRM Management.
  • Maintains high level of awareness, expertise in international applicable regulations and provides input to the development of internal R&D procedures as assigned by RDQRM Management.
  • Ensures rapid communication of QA issues, including potential misconduct or issues of significant deviations with projects/products, to appropriate leaders and colleagues.
  • Defines the joint processes for collaboration on inspection preparation, notification, conduct, response with external providers.
  • Coordinates mock inspections in line with established processes for inspection management process.


Who You Are:

Minimum Qualifications:
  • Minimum 8 years QA experience or other relevant experience with a minimum of 5 years in Clinical QA.
  • Bachelor's degree with a focus on scientific subjects
  • Sound experience with Regulatory Authorities inspections by major authorities (MHRA, FDA, EMA, PMDA)
  • In depth knowledge of drug development processes and respective international regulations/guidelines
  • Broad knowledge of relevant GxP areas (GCP, GLP, GVP)
  • Travel globally up to 20%


Preferred Qualifications:
  • Advanced Degree Preferred
  • Good communication and problem- solving capabilities.
  • Demonstrated ability to work independently and manage time efficiently


Pay Range for this position: $139,400 - 209,200
The offer range represents the anticipated low and high end of the base pay compensation for this position. The actual compensation offered will be determined by factors such as location, level of experience, education, skills, and other job-related factors. Position may be eligible for sales or performance-based bonuses. Benefits offered by the Company include health insurance, paid time off (PTO), retirement contributions, and other prequisites. For more information click here.

About Merck Group

Merck Group Careers

There has never been a more opportune time to join Merck Group, a leading science and technology company in healthcare, life science, and performance materials. Merck Group offers a plethora of job opportunities that cater to a variety of skills and professional aspirations, making it an ideal environment for both seasoned experts and those at the start of their career journey.

Work You’ll Do

At Merck Group, every team member contributes to breakthrough innovations in healthcare, life sciences, and electronics. The company's commitment to diversity and innovation fuels its leadership in various sectors, driving growth and transformation globally. Merck Group’s career paths are diverse, offering positions that challenge individuals to use their skills in new ways every day, supported by robust training programs and development opportunities.

Explore Job Opportunities and Growth

Merck Group is not just about jobs; it's about building a career. With a vast array of positions, from research and development to marketing and sales, the company is keen on hiring and nurturing talent to lead industry transformation. Merck Group’s dedication to professional growth is evident in its comprehensive benefits package and performance management processes that aim to maximize individual potential.

Internship Programs

Starting with an internship at Merck Group can be a pivotal step in securing a prosperous career. Interns gain invaluable industry experience, working alongside seasoned professionals and engaging in projects that offer real-world applications of their studies. Internships often lead to full-time employment opportunities, providing a seamless transition from education to professional employment.

Inclusive Culture and Leadership

Merck Group is proud of its inclusive culture that embraces diversity and fosters an environment where all employees can thrive. The company’s leadership is committed to creating a workplace where diverse ideas lead to innovative outcomes. Merck Group also offers diversity training to ensure all team members are equipped to contribute to the company’s inclusive goals.

Networking and Professional Development

Employees at Merck Group are encouraged to engage in networking and professional development activities that enhance their career trajectories. The company hosts various networking events, workshops, and seminars that are designed to hone skills and foster connections within the industry. Leadership development programs are also a cornerstone, preparing employees for future roles of increased responsibility.

Stay Connected with Merck Group Careers

Interested candidates can explore open positions that match their skills and interests through the Merck Group careers page. The company values curious, creative, and solution-driven team players who are eager to make an impact.

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Merck Group is continuously looking for individuals who are ready to drive innovation and lead in the global marketplace. Whether through full-time positions, internships, or leadership roles, Merck Group offers a career path filled with opportunities for growth, learning, and leadership.
Learn more about Merck Group
Industry
Pharmaceuticals & Biotech
* Ladders Estimates

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