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Manager, Quality Management Systems Life Sciences

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KPMG

3.5

New York, NY

Why you should apply for a job with KPMG:

  • KPMG is on Fairygodboss’ Best Consulting Companies for Women of 2021.

  • 61%

    Reviewers say women are treated fairly and equally to men

  • 85%

    Reviewers say the CEO supports gender diversity

  • We help our employees manage their personal lives with adoption reimbursement, in-home and backup care programs and parental leave.

  • We empower individuals to advance in their education and career, from pre-k to the c-suite with the ambition of changing lives.

  • From telecommuting to a compressed workweek, KPMG offers a culture of flexibility for all employees.

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Position summary

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 Manager in Customer & Operations for our Consulting practice.

Responsibilities:

  • Lead Quality Systems related and Digital Transformation projects including QMS IT strategy, Vendor Selection, Configuration, Change Management, Implementation for various Quality processes such as Complaints Management, CAPA, Change Control, Audits, Supplier Quality, etc. for Life Sciences clients
  • Direct Quality System implementation projects by developing detailed user requirements, functional requirements and technical requirements, design & configuring specifications, integrations, testing and validation
  • Identify potential quality issues at clients and business development targets; provide insights into the trends and expectations of regulatory agencies; deliver guidance on developing effective assessment and remediation frameworks and/or practices
  • Support client relationship development efforts, identify opportunities, support proposals and contribute to the development of the pricing strategies
  • Run fast paced client engagements across multiple functional domains for on-time and quality delivery of work products; track project status, issues, and risks as well as present summary information to clients and executive sponsors as needed
  • Represent KPMG Thought leadership in the area of Quality Management at conferences, in publications and other growth forums as it relates to practice offerings; including serving 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 five years 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.

What are KPMG perks and benefits

Lactation facilities

Post maternity

Fertility

On-ramping/Off-ramping parental leave

Maternity leave coaching

Backup child care

Elder care

Unconscious bias training

Sponsorship program

Networking

Succession planning

Coaching

Sabbatical

Diversity performance

Diversity recruiting

Remote work policy

Part time policy

Paid paternity

Unpaid paternity

Unpaid maternity

Paid maternity

Short term disability

Paid adoptive

About the company

27694

KPMG

Industry: Consulting Services

KPMG’s commitment to DEI is a strategic imperative and is rooted in our vision to have a diverse workforce in which our professionals can reach their fullest potential in an inclusive work environment.  Our KPMG employees have access to a variety of Business Resource Groups (BRG) which are an assembly of partners and professionals who work together to support the firm’s ...

Why you should apply for a job with KPMG:

  • KPMG is on Fairygodboss’ Best Consulting Companies for Women of 2021.

  • 61%

    Reviewers say women are treated fairly and equally to men

  • 85%

    Reviewers say the CEO supports gender diversity

  • We help our employees manage their personal lives with adoption reimbursement, in-home and backup care programs and parental leave.

  • We empower individuals to advance in their education and career, from pre-k to the c-suite with the ambition of changing lives.

  • From telecommuting to a compressed workweek, KPMG offers a culture of flexibility for all employees.

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