Director, Life Sciences - Regulatory Affairs

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 practice.

Responsibilities:

• Deliver advisory services to Life Sciences clients, primarily related to digital transformation across Quality, Regulatory and Operations functions including supply chain, regulatory operations, medical safety, post market surveillance and quality management systems
• Design and implement technology centric solutions in the area of Quality, Regulatory and Operations
• Assist Life Sciences clients validate and deploy cloud based software solutions capable of replacing legacy on premise applications
• Lead business development activities in the Life Sciences industry such as client identification, proposal development, and creation of marketing collateral
• Manage engagements of 5-25 people including adherence to KPMG's financial/cost management policies
• Recruit, hire, and train advisory staff in alignment with service line development strategies

Qualifications:

• A minimum of eight years of experience working in the pharmaceutical, medical device, or biotech industry
• Bachelor's degree from an accredited college/university in Business, Computer Science, or Engineering; Master's degree and prior management consulting experience preferred
• Experience in emerging technologies including Cognitive, Machine Learning, RPA, Data & Analytics, Blockchain and IoT
• Understanding of digital strategy and business execution via technology enablement primarily in the area of Quality and Regulatory; Program management experience running large IT programs with Life Sciences
• Prior experience in designing, implementing and deploying validated solutions in the area of Quality and Regulatory e.g. Veeva RIM, Veeva Vault, Liquent, Trackwise, MasterControl, Documentum and Open Text
• Experience in assessing, designing, developing, testing, and deploying GxP solutions
• Travel as needed
• 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 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.