Johnson & Johnson Careers

Project Manager, External Manufacturers & Supplier Audit

Santa Ana, California; United States
Compliance


Job Description

Requisition ID: 0760190401

Johnson & Johnson Vision is recruiting for a Project Manager, External Manufacturers & Supplier Audit to be located remotely in the United States.


At Johnson & Johnson Vision, we have a bold ambition: to change the trajectory of eye health. That’s why, through our operating companies, we’ve developed solutions for every stage of life—to help people see better, connect better and live better. We partner with eye care professionals to provide some of the world’s leading products and technologies to address refractive error, cataracts, dry eye, and beyond. We are committed to using our reach and size for good and strive to put quality eye care within reach of everyone, everywhere. Visit us at www.jjvision.com. Follow @JNJVision on Twitter and Johnson & Johnson Vision on LinkedIn.

 

Ensures effective supplier quality audit program. Ensures effective Regulatory Health Authority Readiness program for key critical suppliers. Accountable for the proactive identification and alerting of quality issues in time to resolve potential adverse effects to the customer, company image/reputation and/or the business. Accountable for facilitating effective and successful regulatory agency inspections.

Key Responsibilities:

  • Develops and executes organizational and operational policies for the supplier quality audit program.
  • Ensures adherence to approved supplier audit schedule.
  • Conducts supplier audits and gap assessments in support of the supplier quality audit program and regulatory health inspection readiness.
  • Ensures audit reports are issued within the prescribed time frame.
  • Reviews, classifies observations, and approves audit reports.
  • Timely and accurately issues and maintain files associated with supplier and EM audits, re-audits and corrective action responses, and performs updates in the applicable audit tracking systems.
  • Monitors supplier quality audit program performance through the use of trending and metrics.
  • Provides advice and guidance to auditors.
  • Manages external auditors/contract resources and approves contractor invoices.
  • Assists with responses to audit findings and other GMP/QMS related issues as needed.
  • Supports JJRC base business projects and initiatives, as required.
  • Maintains abreast of regulatory changes through industry publications, seminars, participation in trade organizations, and government meetings. Assesses proposed regulations and communicates new requirements to the organization.
  • Follows all company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition.

Qualifications
  • A Bachelors Degree in a related science or engineering field of study is required 
  • A minimum of 8 years of related experience and/or training is required. A minimum of 6 or more years; or Ph.D. with 4 or more years 
  • Demonstrated compliance experience in domestic and/or international quality systems is required
  • Experience dealing with applicable Health Authority inspections is required
  • Ability to read, analyze and interpret scientific and technical journals, financial reports, and legal documents is preferred 
  • Strong understanding in FDA CFR Parts 11, 210, 211, and 820, ICH Q7, ISO 13485 and/or other applicable regulations is required
  • Strong knowledge of quality and compliance in a regulated GxP/QMS environment is required
  • Ability to take in the vital points of the audit and make big picture decisions and observations is required
  • Ability to select, manage and direct a team for/during an audit, as applicable is required
  • Demonstrated statistical skills or knowledge are preferred
  • Manufacturing process understanding is required   
  • Ability to lead a team through a root cause analysis problem is required
  • Ability to effectively present information to management, public groups, and/or boards of directors is required
  • Ability to engage in constructive conflict is required
  • High tolerance for ambiguity in a complex environment. Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists is required
  • Ability to build partnerships both internally and externally. Ability to effectively interface with governmental and independent auditors is required
  • Six Sigma, Lean, ISO lead auditor, or ASQ CQA certification and trainings are preferred
  • The position will be a Remote position within the United States, and may require up to 50% domestic and international travel. The ability to drive and to be comfortable with air travel are absolute requirements

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.



Primary Location
United States-California-Santa Ana-
Other Locations
North America-United States
Organization
AMO US Holdings, Inc.. (6234)
Job Function
Compliance
Requisition ID
0760190401