Senior Associate Quality Management Life Sciences

Kpmg Providence , RI 02940

Posted 2 months ago

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.


  • 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


  • 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, 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, 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.

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.

icon no score

See how you match
to the job

Find your dream job anywhere
with the LiveCareer app.
Mobile App Icon
Download the
LiveCareer app and find
your dream job anywhere
App Store Icon Google Play Icon

Boost your job search productivity with our
free Chrome Extension!

lc_apply_tool GET EXTENSION

Similar Jobs

Want to see jobs matched to your resume? Upload One Now! Remove
Vice President Of Life Sciences COE (National Search)

Gilbane Building Company

Posted 1 week ago

VIEW JOBS 6/14/2022 12:00:00 AM 2022-09-12T00:00 Overview Gilbane Building Company is looking for a leader in Life Sciences building to guide enterprise-wide strategy in construction operations and business development. Gilbane Building Company has an opportunity for a knowledgeable and enthusiastic practice leader to serve as the Director of the Life Sciences Center of Excellence (COE). As a company-wide resource, this position can be located in any U.S. Gilbane office. Responsibilities As Life Sciences Practice Leader you will: * Combine your Life Sciences expertise with operational excellence in the construction of highly specialized and complex research and development and manufacturing facilities to drive outstanding client satisfaction * Introduce Life Sciences business relationships to our organization and bring a strategic perspective to sales and marketing, collaborating with business development professionals to position Gilbane as the partner of choice for Life Sciences construction projects * Share and apply expertise and knowledge of the life sciences industry internally through the organization. * Track industry trends and provide innovative service improvements and technologies to ensure Gilbane is aligned with Life Sciences client objectives as the market grows and evolves. * Act as the Gilbane Life Sciences client advocate by understanding and meeting client strategic business needs and working with internal teams to develop project approaches with a client perspective. * Achieve world-class performance through the aggregation of best practices, processes, procedures, tools and techniques specific to Life Sciences and bring our collective national experience to local teams * Identify and present relevant prior experience and facility solutions from similar projects across Gilbane to support both operations and sales objectives * Provide advanced business objectives to clients as they pertain to facilities * Present strategic cost and schedule models for project delivery * Understand the owner's perspective from experience working for a life sciences facilities client or developer of life sciences facilities is a highly sought differentiator Qualifications Key Competencies * Leverage Business Insights - Understand and act on industry trends, local market and economic conditions and our business model to make decisions and create competitive advantage. * Deploy a Strategic Mindset - Take a broad, global perspective when considering proactive solutions to long-term opportunities and risks that might develop in the future. * Display Emotional Intelligence - Demonstrate the capacity to recognize feelings and patterns of behavior and those of others. Manage emotions effectively in ourselves and our relationships. * Build High Performing Teams - Demonstrate the capacity to recognize our feelings and patterns of behavior and those of others. Manage emotions effectively in ourselves and our relationships. * Drive Team Accountability - Determine priorities and delegate work; monitor and communicate progress. Establish measures to assess the impact, quality and timeliness of results; praise success and learn from mistakes. * Coach and Develop Others - Provide feedback, instruction, and development guidance to help others excel in their current or future job responsibilities. Plan for and support development of individual skills and abilities. * Experience/Education * 15-20+ years' experience in construction or design/build of Life Sciences facilities * BS or MS degree in Construction Management/Engineering or related field * Or equivalent combination of education and experience Knowledge/Skill & Abilities * Collaborative relationship builder with ability to work and lead virtually and in-person across multiple geographies * Proven success in strategic sales and marketing, as well as client relationships * Team player with agility to align role to each unique circumstance working with seasoned and new business development and construction operations team members * Successful delivery of Life Science research and development or manufacturing facilities Gilbane offers an excellent total compensation package which includes competitive health and welfare benefits and a generous profit-sharing/401k plan. We invest in our employees' education and have built Gilbane University into a top training organization in the construction industry. Qualified applicants who are offered a position must pass a pre-employment substance abuse test. Gilbane is not accepting unsolicited resumes from third party recruiters at this time. Gilbane is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to age, color, national origin, race, religion, sex, sexual orientation, gender identity, protected veteran status, or disability status. Gilbane Building Company Providence RI

Senior Associate Quality Management Life Sciences