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KPMG Manager, Life Sciences, Digital Solutions - Regulatory Affairs, Quality, Safety in Boston, Massachusetts

Business Title: Manager, Life Sciences, Digital Solutions - Regulatory Affairs, Quality, Safety

Requisition Number: 63993 - 39

Function: Advisory

Area of Interest:

State: MA

City: Boston

Description:

Historically, the travel requirement for this position has ranged from 80-100%. The safety and well-being of our people continues to be the top priority, and our decisions around travel are informed by government COVID-19 response directives, recommendations from leading health authorities, and guidance from a number of infectious disease experts. For now, all KPMG business travel, international and domestic, is currently restricted to client-essential sales/delivery activity only. At some point in the future and with the safety of people as the critical factor, the travel requirement will likely increase, possibly to previous levels, but KPMG is committed to balancing client requirements with new delivery capabilities.

The KPMG Advisory practice is currently our fastest growing practice. We are seeing tremendous client demand, and looking forward we don't anticipate that slowing down. In this ever-changing market environment, our professionals must be adaptable and thrive in a collaborative, team-driven culture. At KPMG, our people are our number one priority. With a wealth of learning and career development opportunities, a world-class training facility and leading market tools, we make sure our people continue to grow both professionally and personally. If you're looking for a firm with a strong team connection where you can be your whole self, have an impact, advance your skills, deepen your experiences, and have the flexibility and access to constantly find new areas of inspiration and expand your capabilities, then consider a career in Advisory.

KPMG is currently seeking a Manager in Customer & Operations for our Consulting (https://advisory.kpmg.us/) practice.

Responsibilities:

  • Lead implementation of technology solutions for Life Sciences clients in the area of Quality, Regulatory, and/or Safety

  • Assist Life Sciences clients deploy cloud-based software solutions in efforts to replace legacy on premise applications

  • Identify opportunities to implement automation or emerging technologies to streamline processes in Life Sciences

  • Manage workstreams on technology implementation projects related to data, processes, solution design and/or requirements

  • Facilitate engagement decisions, including work plan and timeline, project management, resource allocation, and career development of team members

  • Structure and perform analysis on regulatory-related processes, data, business requirements, operating models, IT systems, etc.

Qualifications:

  • Minimum of five years of relevant work experience within the pharmaceutical and/or medical device industry

  • Bachelor's degree in an appropriate field from an accredited college/university; Master's degree from an accredited college/university preferred

  • Prior professional services or consulting experience preferred

  • Strong understanding of Regulatory, Safety and/or Quality related data and documents as well as experience with Regulatory Information Management (RIM) systems, Document Management systems, Pharmacovigilance systems and/or Quality Management Systems

  • Proven experience serving on an implementation team for RIM, Document Management, QMS and/or PV systems (preferred) as well as experience in emerging technologies including Machine Learning, RPA, Data & Analytics

  • Experience implementing systems under Computer Systems Validation (CSV) procedures as well as excellent foundational skills including strong analytical, written and verbal communication skills, MS Office expertise, impactful client presence, compelling facilitation and presentation skills

KPMG LLP (the U.S. member firm of KPMG International) offers a comprehensive compensation and benefits package. KPMG is an affirmative action-equal opportunity employer. KPMG complies with all applicable federal, state and local laws regarding recruitment and hiring. All qualified applicants are considered for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other category protected by applicable federal, state or local laws. The attached link ( https://assets.kpmg.com/content/dam/kpmg/us/pdf/2018/09/eeo.pdf) contains further information regarding the firm's compliance with federal, state and local recruitment and hiring laws. No phone calls or agencies please.

GL: 4

GF: 15292

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