Senior Associate Quality Management Systems Life Sciences

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 Senior Associate Quality Management Life Sciences in Customer & Operations for our Consulting practice.

Responsibilities:

• Support Quality Systems related and Digital Transformation projects including QMS IT strategy, Vendor Selection, Configuration, Change Management and Implementation for various Quality processes such as Complaints Management, CAPA, Change Control, Audits, Supplier Quality, etc. for Life Sciences clients
• Reinforce Quality System implementation projects by developing detailed user requirements, functional requirements and technical requirements, design & configuring specifications, integrations, testing and validation
• Drive progress against project milestones to help ensure timely delivery of project deliverables, review the work product of associates, provide direction and training as necessary
• Provide input into engagement decisions, including work plan and timeline, project management, resource allocation and career development of team members
• Perform analysis on QMS-related data, processes, business requirements and operating models
• Support projects related to process transformation, technology-enabled transformation, measurable improved operational performance, preparation for Quality mandates and organizational redesign

Qualifications:

• Minimum two years of work experience related to Quality Systems within the pharmaceutical, Biotech and/or medical device industry
• Bachelor's degree in an appropriate field from an accredited college/university required; master's degree from an accredited college/university preferred
• Experience with operational process improvement initiatives in a pharmaceutical and/or medical device industry; prior professional services or consulting experience preferred
• Strong understanding of various Quality system regulations (21 CFR Part 820, QSReg) and standards including ISO13485 including Design Controls, Document Controls, Production and Process Controls, Corrective and Preventive Actions, Labeling and Packaging Controls, Records Management and Servicing
• Experience with any of the Quality Management Systems including Trackwise, Trackwise Digital, Veeva Vault QMS, IQVIA Pilgrim, ComplianceQuest, MasterControl, ETQ and/or Document Management systems preferred
• Excellent foundational skills including strong analytical, written and verbal communication skills, MS Office expertise, impactful client presence, compelling facilitation and presentation skills
• Applicants must be currently authorized to work in the United States without the need for visa sponsorship now or in the future and the ability to travel as necessary

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, citizenship status, 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.

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).       /