Business Title: Director Life Sciences QMSRequisition Number: 113311 - 58Function: AdvisoryArea of Interest:State: NJCity: MontvaleDescription: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 (https://advisory.kpmg.us/) 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
Additional Responsibilities:
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
Qualifications:
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
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 (https://www.kpmguscareers.com/why-kpmg/#benefits) '.Follow this link to obtain salary ranges by city outside of CA: https://kpmg.com/us/en/how-we-work/pay-transparency.html/?id=M120224KPMG 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 'https://assets.kpmg.com/content/dam/kpmg/us/pdf/2018/09/eeo.pdf? '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: 3GF: 15292