4 days old

Director, Quality Management/ Life Sciences

Short Hills, NJ 07078
**Business Title:** Director, Quality Management/ Life Sciences

**Requisition Number:** 84577 - 59

**Function:** Advisory

**Area of Interest:**

**State:** NJ

**City:** Short Hills


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 Director in Customer & Operations for our Consulting (https://advisory.kpmg.us/) practice.


+ Develop and maintain relationships with key client stakeholders, identify opportunities and direct enterprise-wide strategic aligned projects in the Quality Management domain

+ Identify potential quality issues at clients and business development targets, provide insights into the trends and expectations of regulatory

+ Agencies provide guidance on developing effective assessment and remediation frameworks and/or practices

+ Run fast paced client engagements across multiple functional domains for on-time and quality delivery of work products; responsible for overall engagement planning, budgeting, staffing, financial management, deliverables and management of the engagement team members

+ Oversee continuous improvement of solutions within quality management to address changing regulatory environment and market demands including: CAPA, Complaints Management, Document Control, Quality Operation Controls and Quality Audit

+ Represent KPMG thought leadership in the area of Quality Management at conferences, in publications and other growth forums as it relates to practice offerings

Additional Responsibilities:

+ Serve 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


+ Minimum eight years of consulting or business experience or combination thereof in the Quality domain within the Life Science industry (Pharmaceutical, Medical Device, BioTech and Clinical Research Organization)

+ Bachelor's degree from an accredited college/university, preferably in Biology, Chemistry, Pharmacy, Biochemistry, Biomedical Engineering, or related field; graduate degree in a Healthcare or Life Sciences discipline such as MA, MSc, MPH, PhD or MD, or a Master's degree in Business or Healthcare Administration from an accredited college/university is highly preferred

+ Project and Program management experience including resource management, budgetary monitoring and delivery

+ Knowledge of governing body regulations, statutes and guidelines including 21 CFR Part 11, 210, 211, 820, HIPPA, ISO 9001, ISO 13485, EU Annex 11, EU MDR

+ Ability to travel as necessary

+ 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.

+ Applicants must be currently authorized to work in the United States without the need for visa sponsorship now or in the future

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 contains further information regarding the firm's compliance with federal, state and local recruitment and hiring laws. No phone calls or agencies please.

At KPMG, any partner or employee must be fully vaccinated or test negative for COVID-19 in order to go to any KPMG office, client site or KPMG event. In some circumstances, individuals who are not fully vaccinated may also be required to have a reasonable accommodation to not be fully vaccinated for COVID-19.

**GL:** 3

**GF:** 15292


Posted: 2022-05-13 Expires: 2022-06-15

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Director, Quality Management/ Life Sciences

Short Hills, NJ 07078

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