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KPMG Manager, Quality Management Systems/ Life Sciences in Boston, Massachusetts

Business Title: Manager, Quality Management Systems/ Life Sciences

Requisition Number: 71584 - 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:

  • Support KPMG Life Sciences services through insights about industry trends and customer needs in the area of Quality Management Systems

  • Manage the strategy execution and implementation of Quality Management Systems, Digital Transformation initiatives in Quality and Digital Health Quality programs

  • Identify potential quality issues at clients and business development targets; provide insights into the trends and expectations of regulatory agencies; deliver guidance on developing effective assessment and remediation frameworks and/or practices

  • Support client relationship development efforts, identify opportunities, support proposals and contribute to the development of the pricing strategies

  • Run fast paced client engagements across multiple functional domains for on-time and quality delivery of work products; track project status, issues, and risks as well as present summary information to clients and executive sponsors as needed

  • Represent KPMG Thought leadership in the area of Quality Management at conferences, in publications, and other growth forums as it relates to practice offerings; including serving as a Performance Management Leader (PML) for the staff and mentor team members for their career growth; actively participate in staff recruitment and retention activities

Qualifications:

  • Minimum five years of work experience related to Quality Systems within the pharmaceutical, Biotech and/or medical device industry

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

  • Experience with operational process improvement initiatives in a pharmaceutical and/or medical device industry; prior professional services or consulting experience preferred

  • Strong understanding of various Quality system regulations (21 CFR Part 820, QSReg) and standards including ISO13485 including Design Controls, Document Controls, Production and Process Controls, Corrective and Preventive Actions, Labeling and Packaging Controls, Records Management and Servicing.

  • Experience with any of the Quality Management Systems including Trackwise, Pilgrim, Master Control, Veeva, ETQ and/or Document Management systems preferred

  • 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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