Manager, Quality and Regulatory Affairs (Life Sciences) (Boston)

**Business Title:** Manager, Quality and Regulatory Affairs (Life Sciences)

**Requisition Number:** 113224 - 40

**Function:** Advisory

**Area of Interest:**

**State:** MA

**City:** Boston

**Description:**

KPMG Advisory practice is currently our fastest growing practice. We are seeing tremendous client demand, and looking forward we do not 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 Life Sciences Solutions for our Consulting ( ) practice.

Responsibilities:

+ Lead Quality related Transformation projects for various Quality processes such as Complaints Management, CAPA, Change Control, Audits, Supplier Quality, etc. for Life Sciences clients

+ Manage RA projects by developing detailed project plans

+ 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 solutions that drives business value

+ Support client relationship development efforts, identify opportunities, assist with 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 Digital Transformation in Quality Management at conferences, in publications, and other forums as it relates to practice offerings

Qualifications:

+ Minimum five years of recent work experience related to Quality and Regulatory Affairs within the pharmaceutical, Biotech and/or medical device industry

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

+ Experience in Regulatory Affairs compliance, process and controls

+ Prior experience with developing and implementing Regulatory Affairs Strategies

+ Travel up to 80%

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

KPMG complies with all local/state regulations regarding displaying salary ranges. If required, the ranges displayed below or via the URL below are specifically for those potential hires who will work in the location(s) listed. Any offered salary is determined based on relevant factors such as applicant's skills, job responsibilities, prior relevant experience, certain degrees and certifications and market considerations. In addition, the firm is proud to offer a comprehensive, competitive benefits package, with options designed to help you make the best decisions for yourself, your family, and your lifestyle. Available benefits are based on eligibility. Our Total Rewards package includes a variety of medical and dental plans, vision coverage, disability and life insurance, 401(k) plans, and a robust suite of personal well-being benefits to support your mental health. Depending on job classification, standard work hours, and years of service, KPMG provides Personal Time Off per fiscal year. Additionally, each year the firm publishes a calendar of holidays to be observed during the year and provides two firmwide breaks each year where employees will not be required to use Personal Time Off; one is at year end and the other is around the July 4th holiday. Additional details about our benefits can be found towards the bottom of our KPMG US Careers site at 'Benefits & How We Work ( ) '.

Follow this link to obtain salary ranges by city outside of CA: \_3\_25KPMG 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, citizenship status, 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.

KPMG does not currently require partners or employees to be fully vaccinated or test negative for COVID-19 in order to go to KPMG offices, client sites or KPMG events, except when mandated by federal, state or local law. In some circumstances, clients also may require proof of vaccination or testing (e.g., to go to the client site).

KPMG recruits on a rolling basis. Candidates are considered as they apply, until the opportunity is filled. Candidates are encouraged to apply expeditiously to any role(s) for which they are qualified that is also of interest to them.

**GL:** 4

**GF:** 15294

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