Director, Quality Management Systems - Life Sciences

Kpmg Short Hills , NJ 07078

Posted 3 weeks ago

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.

Director, Quality Management Systems, Life Sciences

KPMG is currently seeking a Director, Life Sciences Operations Advisory in our Management Consulting practice.

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, provide 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

  • Run fast paced engagements of 5-25 staff across multiple functional domains including directing subcontractors and off-shore resources

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

  • Track project status, issues, and risks as well as present summary information to clients, partnerships, and executive sponsors as needed

Qualifications:

  • A minimum of ten years of experience in the area of Quality Management Systems within the Life Sciences Industry.

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

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

  • Demonstrates proven 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.

  • Demonstrates experience 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, Pilgrim, Veeva Vault QMS, etc.

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. 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.


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Director, Quality Management Systems - Life Sciences

Kpmg