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Manager, Quality Management Systems/Life Sciences

Posted on Apr 6, 2021 by KPMG Consulting Services

Boston, MA 02297
Research
Immediate Start
Annual Salary
Full-Time


KPMG is currently seeking a Manager in Customer & Operations for our Consulting 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
Bachelors degree in an appropriate field from an accredited college/university required; Masters 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
Applicants must be currently authorized to work in the United States without the need for visa sponsorship now or in the future




Reference: 1152692061

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