Massachusetts Green Jobs

Director, Quality Management Systems -Life Sciences

Boston, Massachusetts

Requisition #: 46013

Practice Area: Advisory

Location: Chicago, IL; Boston, MA; Short Hills, NJ; New York, NY; Philadelphia, PA; Dallas, TX

Known for being a great place to work and build a career, KPMG provides audit, tax and advisory services for organizations in today's most important industries. Our growth is driven by delivering real results for our clients. It's also enabled by our culture, which encourages individual development, embraces an inclusive environment, rewards innovative excellence and supports our communities. With qualities like those, it's no wonder we're consistently ranked among the best companies to work for by Fortune Magazine, Consulting Magazine, Working Mother Magazine, Diversity Inc. and others. If you're as passionate about your future as we are, join our team.

KPMG is currently seeking a Director, Quality Management Systems for the Life Sciences Operations Advisory in ourpractice.

Responsibilities:

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

• 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

• Manage the strategy execution and implementation efforts of Quality Management Systems-related client engagements, including these focus areas - client engagement delivery (i.e. remediating warning letters, consent decrees, development & execution of effective, efficient and sustainable quality management systems); regulatory agency interactions

• Develop and maintain relationships with executives at key clients, identify opportunities, develop 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; Accountable for overall engagement planning, budgeting, staffing, financial management, deliverables, management of the engagement team members

• 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:

• A minimum of ten years of experience in the area of Quality Management Systems within the Life Sciences Industry; prior relevant experience with any global consulting companies serving Life Sciences industry is preferred

• Bachelor's degree in a scientific or engineering discipline from an accredited college or university; MBA is preferred

• Demonstrated extensive knowledge with identifying and remediating pharmaceutical, biotech, medical device and diagnostic businesses with potential quality issues

• Experience in managing the strategy execution and implementation efforts of Quality Management Systems-related initiatives, including but not limited to remediating warning letters, consent decrees, and development and execution of effective, efficient and sustainable quality management systems

• Prior knowledge and subject matter specialty in standard industry practices with Quality Management Systems relating to practices involving Good Manufacturing Practices (GMP), Good Clinical Practices (GCP), Good Pharmacovigilance Practices (GPP), and/or Good Laboratory Practices (GLP)

• Experience with leading QMS platforms such as Trackwise, MasterControl, ETQ, Pilgrim, and Veeva Vault QMS

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, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other category protected by applicable federal, state or local laws. Thecontains further information regarding the firm's compliance with federal, state and local recruitment and hiring laws. No phone calls or agencies please.

Our Benefits

Health

KPMG offers a range of medical insurance options to meet your needs as well as prescription drug coverage, health care flexible spending accounts, and dependent day care flexible spending accounts.

Personal Time Off (PTO)

Up to 30 PTO Days per year (depending on job classification/level/years of service).

Financial

• 401(k) and Pension Plans

• Dependent Care Flexible Spending Account

• Health Care Flexible Spending Account

• Mortgage Assistance Program

• HomeBenefits@Work Program

• Hyatt Legal Plan

• Benefits vary by employment status.