Director Life Sciences QMS

KPMG - Montvale, NJ

Full-time - Director

Montvale, NJ

Professional, Scientific, and Technical Services

About the position

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 Director Life Sciences in Customer & Operations for our Consulting practice.

Responsibilities

• 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.
• 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; be 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.
• 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.

Requirements

• Minimum ten to fifteen years of Regulatory experience in the Medical device, consulting and/or business experience or combination thereof in the Quality domain within the Life Science industry (Pharmaceutical, Medical Device, BioTech and Clinical Research Organization).
• Bachelors 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 Masters 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.
• Experience in writing, reviewing technical documentations.
• Prior experience in interacting with Notified Bodies in review of the technical documentation and obtaining Notified Body certification.
• Ability to travel as necessary.

Benefits

• Disability insurance
• Health insurance
• Dental insurance
• 401(k)
• Vision insurance
• Life insurance